The ICONACY i-Hip ™ System was cleared for marketing in the U.S. by the Food and Drug Administration on September 4, 2012 (K121034). The goal of the i-Hip™ total hip replacement is to give surgeons and patients the most high-tech, high quality design while maintaining clinically proven geometries.

Instrument System

Prosthesis

Surgical Technique

Stability

The i-Hip™ was designed as a whole to provide optimal range of motion, fixation, and durability at the articular surface. The holistic design, combined with precise engineering and manufacturing, offers a highly flexible system that restores biomechanical function of the hip.

Clinically Proven Geometries

Triple Stem Image

Designed for axial stability by creating cortical bone contact both at the medial and lateral endosteal cortices

  • A comprehensive offering of offsets and femoral head options provides intra-operative flexibility to restore leg length, range of motion, reduce wear at the articular surface, and bio-mechanical function.

Proven utilized poly liner locking mechanism with over 20 years of use

  • Cup-to-head ratio designed to gain the largest size femoral head within a given cup without sacrificing bearing thickness
  • Cup provided with a “Ring Secured” locking ring that will not spin during insertion and an industry leading secured torque and lever out ratios designed for interoperative liner removal without damaging the acetabular component or liner

Large diameter heads (36mm) promote increased stability

  • For an identically placed cup and stem, a larger head provides increased range of motion before impingement and reduces the risk of dislocation
  • Clinical studies show that large diameter heads (i.e., 32mm and greater) can be used to reduce the rate of dislocation

Advanced Material Technologies

Cup Liner

Fourth-generation, highly cross linked (i.e., HXL) UHMWPE

  • In vitro test results indicate acceptable wear rates with 36mm (I.D.) X 54mm bearing

Porous, titanium plasma spray coating provides initial press fit stability

  • Cementless, titanium hemispherical socket fixation designs have historically had excellent clinical results at 8- to 10-year follow-ups
  • Femoral components with circumferential porous coating have historically performed well in patients at an average follow-up period of 8 years

Contemporary Implant Designs

Femoral Stem Figure

Recognized femoral stem design with progressive features offer surgical adaptability

  • Designed to Gradually Transition between selected sizes by increasing in all dimensions as the size selected increases
  • Narrowed femoral neck designed to allow increased range of motion before impingement
  • Shortened femoral stem lengths (i.e., 15-20% less than historic designs with this geometry type) to accommodate various surgical approaches

Fully coated hemispherical cup designed for biologic fixation

  • Familiar 180-degree hemispherical, forged Ti-6Al-4V alloy cups
  • 2 & 3 hole cups (3 hole version approved) in both standard and finned provide immediate fixation with fins or cancellous bone screws. The ring is designed to eliminate “spinning” during the insertion process

Modular femoral heads facilitate functional versatility with various intraoperative bearing options

  • Ceramic and Cobalt Chrome femoral heads available in 28mm, 32mm, and 36mm diameters to assist with ensuring adequate fit and stability
  • Femoral heads are offered in multiple offsets and lengths to optimize intra-operative flexibility to restore bio-mechanical function of the hip. Please see the chart below.

Simplified Instrument System

Friction Lock Inserter

Friction-lock acetabular insert trials

  • Designed for simplified trialing, insertion during operation.
  • Eliminates steps normally required by competitive instrument systems, thus simplifying surgery and reducing time and effort.

Intraoperative femoral stem offset selection with modular neck trials

  • Modular neck trials in standard, lateral and reduced lateral offerings for intraoperative use
  • Fail-safe, “keyed” interface feature ensures that only the correct modular neck trial is matched to the associated femoral stem rasp

Porous, titanium plasma spray coating provides initial press fit stability

  • Cementless, titanium hemispherical socket fixation designs have historically had excellent clinical results at 8- to 10-year follow-ups
  • Femoral components with circumferential porous coating have historically performed well in patients at an average follow-up period of 8 years

Dependable acetabular cup impactor

  • Solid lock interface to promote predictable cup placement

We Are Committed to Providing Best-in-class Service to Our Customers

Do you have questions? Are you looking for more information?

General Description of Implant

The ICONACY™ i-Hip™ GT Femoral Stem System

The stem necks have a standard 12/14 taper to accommodate the socket of the associated modular femoral heads, either wrought Co-Cr or Alumina Matrix ceramic.

The wrought Co-Cr femoral heads are available in 3 head diameters, 28mm, 32mm, and 36mm. The heads are available in 5 common neck lengths: -4mm, +0mm, +4mm, +8mm and +12mm. The 32mm and 36mm heads are also available in -6mm. The femoral heads can be used on any i-Hip™ femoral stem for any of the associated neck length options.

The Alumina Matrix femoral heads are also available in the 3 same head diameters.  The nature of the material requires the heads only have 3 or 4 neck lengths: -4mm, +0mm, +4mm, and +7/8mm (Table 3). The femoral heads can be used on any i-Hip™ femoral stem for any of the associated neck length options.

Both femoral heads have a color buff finish to minimize wear. The wrought Co-Cr femoral heads have a color buff finish to 0.05µm Max Ra. The Alumina Matrix femoral heads have a color buff finish of 0.02µm Max Ra. All heads have a 12/14 taper socket to mate with the taper of the femoral stems.

Ceramic Neck Length Options
CrCo Neck Length Options

ICONACY ™ i-Hip™ Instrument System:

Instrument Use, Care, Cleaning, Disinfection, Inspection, Maintenance, and Sterilization.

Instrument Use

Carefully read all instructions and be familiar with the surgical technique prior to use and use universal precautions when handling contaminated or biohazardous components/materials.

Before using a product placed on the market by ICONACY, the operating surgeon should study carefully the following recommendations, warnings, and instructions, as well as the available product-specific information (e.g., product literature). ICONACY is not liable for complications that may arise from the use of the device in circumstances outside of ICONACY’s control including, but not limited to, product selection and deviations from the devices indicated uses or surgical techniques.

Instrument Care
  • Failure to follow these instructions could result in instrument breakage and potential adverse effects on user(s) or patient.
  • Use only instruments specifically designed for use with their associated devices.
  • Misuse reduces useful life and/or increases injury risk. Repeated processing according to these instructions has minimal effect on ICONACYreusable manual instruments. End of life is normally determined by wear and damage due to use.
  • Refer to AORN Standards, Recommended Practices, and guidelines for guidelines related to proper care, maintenance, reprocessing, and handling of surgical instruments.
Warnings
  • Instruments must be thoroughly cleaned prior to sterilization. Instruments that are not clean may not be effectively sterilized.
  • Reuse of a single-use device that has come in contact with blood, bone, tissue, or other body fluids may lead to patient or user injury. Possible risks associated with reuse of a single-use device include, but are not limited to, mechanical failure and transmission of infectious agents.
  • Automated cleaning may not be effective. A thorough, manual cleaning process is recommended.
  • Do not use instruments/provisional trials that are deformed, corroded, damaged, or worn. They may not perform as intended.
  • Do not subject stainless steel to chlorine or chloride-based agents. Corrosion or discoloration may occur.
  • Disinfection is only acceptable as an adjunct to full sterilization for reusable surgical instruments.
  • Use only compatible components with the I-Hip instrument system (see product literature for the list of compatible components).
Precautions
  • Inspect all instruments carefully prior to each use.
Instrument Cleaning and Disinfection
  • Where applicable, disassemble instruments prior to cleaning. Refer to www.iconacy.com for the applicable instrument disassembly instructions.
  • Thoroughly clean and dry reusable instruments immediately after use to minimize corrosion and potential cross-contamination.
  • Neutral 6.0-8.0pH enzymatic and cleaning agents with low-foaming/low-sudsing surfactants are preferred and recommended byICONACY. Alkaline agents with pH of 12 or less may be used where required by law or local ordinance. Alkaline agents should be followed with a neutralizer and thorough rinsing. All cleaning agents should be prepared at the use-dilution and temperature recommended by the manufacturer.
  • Fresh cleaning solutions should be prepared when existing solutions become grossly contaminated (bloody and/or turbid).
  • Completely submerge instruments in enzyme solution and allow to soak for 20 minutes. Use a soft-bristled, nylon brush to gently scrub the device until all visible soil has been removed. Particular attention must be given to crevices, lumens, mated surfaces, connectors and other hard-to-clean areas. Lumens should be cleaned with along, narrow, soft-bristled brush (i.e., pipe cleaner brush).
  • Remove the device from the enzyme solution and rinse in warm (38°C-48°C) water for a minimum of 3 minutes. Thoroughly and aggressively flush lumens, holes, and other difficult-to reach areas.
  • Place prepared cleaning agents in a sonication unit.Completely submerge device in cleaning solution and sonicate for 10minutes at 45-50kHz.
  • Rinse instrument in purified water for at least 3 minutes or until there is no sign of blood or soil on the device or in the rinse stream. Thoroughly and aggressively flush lumens, holes and other difficult-to-reach areas.
  • Repeat the sonication and rinse steps above.
  • If stainless steel instruments are stained or corroded, an acidic,anti-corrosion agent in an ultrasonic cleaner may be sufficient to remove surface deposits. Care must be taken to thoroughly rinse acid from devices. Acidic, anti-corrosion agents should only be used on an as-needed basis.
  • Remove excess moisture from the instrument with a clean, absorbent and non-shedding wipe
Instrument Inspection and Functional Testing
  • Carefully inspect each device to ensure that all visible blood and soil have been removed. If contamination is noted, repeat the cleaning and disinfection.
  • Check the action of moving parts (e.g., hinges) to ensure smooth operation throughout the intended range of motion.
  • Check instruments with long slender features for distortion.
  • Where instruments form part of a larger assembly, check that the devices assemble readily with mating components.
  • If damage or wear is noted that may compromise the function of the instrument, do not use the device and contact your ICONACYrepresentative for a replacement.
Instrument Maintenance
  • After cleaning, lubricate moving parts with a water soluble lubricant, reassemble, and tighten screws where appropriate.
Instrument Sterilization Instructions
  • The provided sterilization instructions are consistent with ANSI/AAMI/ISO standards and guidelines. They should be used for items supplied non-sterile, for reprocessing reusable devices, and sterile items that were opened but unused.
  • In the event of inadvertent loss of sterility while preparing for surgery, sterile instruments may be sterilized only once for immediate use, following the recommended sterilization specifications for reusable instruments.
  • Do not reuse instruments or devices labeled for single use only. Reuse of a single-use device that has come in contact with blood, bone, tissue, or other body fluids may lead to patient or user injury. DO NOT RESTERILIZE single-use only components that have been contaminated with body fluids or debris or previously implanted. Possible risks associated with reuse of a single-use device include, but are not limited to, mechanical failure, and transmission of infectious agents.
  • Where possible, reusable instruments should be disassembled for sterilization.
  • TheCODMAN®QUAD-LOCK ™ Sterilization Container System (K120117) should be used to organize and protect the surgical instruments for sterilization by pre-vacuum steam following the recommended sterilization specifications for reusable instruments. For additional information on this sterilization container system, refer to the manufacturer’s instructions for use.
  • Do not use the original plastic cavities or lids for resterilization.
  • Do not stack heavy items on top of any sterilization cases made from plastic. The resulting deformation can cause cracking of the plastic material.
  • Polysulfone instruments may show crazing and/or cracking due to steam boiler chemicals and lubricants.
  • Sterile, packaged instruments should be stored in a designated, limited access area that is well ventilated, and provides protection from dust, moisture, insects, vermin, and temperature and humidity extremes.
  • Sterile, packaged instruments should be examined carefully prior to opening to ensure that there has been no loss of package integrity
Recommended Sterilization/Resterilization Specifications

Instruments are supplied non-sterile and must be cleaned and sterilized prior to use in surgery. Follow the sterilizer manufacturer’s instructions for loading patterns and selection of sterilization parameters. Drying times vary according to load size and should be increased for larger loads. The following parameters are recommended as they have been validated for a Sterility AssuranceLevel of 10-6. The adequacy of any sterilization procedure must be suitably tested. It is critical that appropriate process parameters be validated for each facility’s sterilization equipment and product load configuration by trained personnel in sterilization processes to substantiate the reliability and reproducibility of the process.

ICONACY™ i-Hip™ Prosthesis

Description

The ICONACY i-Hip prosthesis consists of a collarless, tapered, forged titanium alloy femoral stem, mated to a cobalt chrome alloyor ceramic modular femoral head. This femoral construct articulates with an acetabular device assembly. The acetabular device assembly consists of a hemispherical titanium alloy cup (i.e., shell) coupled with a highly cross linked ultra-high molecular weight polyethylene (HXL-UHMWPE) liner. Forty percent of the femoral stem is circumferentially coated with a titanium coating designed to attain a cementless, press-fit fixation.

The acetabular cup is machined from forged Ti-6Al-4V ELI alloy. The cup has a threaded polar hole for insertion and two or three screw holes to permit optimal fixation into the best available bone. The outer hemispheric surface of the cup has a titanium plasma spray coating for cementless, press-fit fixation. A titanium locking ring is fixed into a groove on the cup to engage the groove on the HXL-UHMWPE liner.

Indications for Use

The ICONACY i-Hip system is indicated for the following conditions:

  • A severely painful and/or disabled hip joint as a result of osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
  • Avascular necrosis of the femoral head.
  • Acute traumatic fracture of the femoral head or neck.
  • Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
  • Certain cases of ankylosis
  • Nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. 

The ICONACY i-Hip system consists of femoral stem and acetabular cup (i.e., shell) porous coated components intended for cementless, press-fit fixation.

Contraindications

Use of this device is contraindicated in the following conditions:

  • Active local or systemic infection.
  • Bone stock that is inadequate for support or fixation of the prosthesis. Poor bone quality, i.e., osteoporosis, may result in considerable migration of the prosthesis or possible fracture of the femoral shaft and/or lack of adequate supporting bone.
  • Loss of musculature, neurovascular compromise or vascular deficiency in the affected limb which renders the procedure unjustifiable.
  • Charcot’s or Paget’s disease.
  • Skeletal immaturity.
  • Any mental or neuromuscular disorder that would create an unacceptable risk of prosthesis instability, prosthetic fixation failure, or complications in postoperative care.
  • Obesity, as an extremely overweight patient can produce loads on the device that can lead to failure of the device or to its fixation.
Warnings
  • Implant selection is critical. The proper sizes must be used to obtain optimal stability and longevity of the components for total hip arthroplasty. Proper implant selection includes design, fixation and environmental variables including patient weight, age, bone quality and size, activity level and preoperative level of health, as well as the surgeon’s experience and familiarity with the implants, instruments and surgical technique. Longevity and stability may be affected by these factors.
  • The following patient conditions tend to impose severe loading on the affected extremity and place the patient at higher risk of device failure: excessive weight, manual labor, active participation in sports, high levels of activity, falls, alcohol or drug addiction, or other disabilities. Other conditions can adversely affect the performance of the device and ultimate clinical results; they include osteoporosis and poor bone stock, metabolic disorders (diabetes), steroid therapy, tumors of supporting bone, and a history of general or local infections.
  • Excessive physical activity or trauma to the replaced joint may contribute to premature failure of the hip replacement by causing a change in position of the device, device fracture, and/or excessive wear. The patient should be informed that factors such as weight and activity levels may significantly affect device performance (see patient Information section).
  • Do not substitute another manufacturer’s device for any component of the i-Hip prosthesis system. Any such use could compromise the intended performance of the ICONACY device. The taper size of the femoral stem must be matched to the taper size of the femoral head.
  • The smaller sized femoral components are intended for patients with smaller intramedullary canals. The geometry results in a decrease in fatigue strength and load bearing. Patients with a high physical activity, poor bone quality, or who are overweight may not be suitable candidates for the smaller size stem.
  • The surgical and postoperative management of the patient must consider all existing conditions. Mental attitudes or disorders resulting in a patient’s failure to comply with the surgeon’s orders may delay postoperative recovery and increase the risk of adverse effects including implant or implant fixation failure
Precautions
  • Hip prosthesis components should never be reimplanted. Even though the device appears undamaged it may have developed microscopic imperfections that may result in device failure.
  • TheICONACY I-Hip prosthesis has not been evaluated for safety and compatibility in the MR environment. The ICONACY I-Hip prosthesis has not been tested for heating or migration in the MR environment.
  • Seat modular femoral heads firmly on the femoral component to prevent disassociation. Machined taper surfaces must be clean and dry to ensure proper seating and assembly.
  • It is recommended that components at least one size larger and smaller than preoperatively determined be available during surgery to accommodate intraoperative selection of the optimal size.
  • Specialized instruments are available and should be used to help ensure accurate implantation of the components.
Adverse Effects
  • Dislocation or change of position of the components can occur due to excessive patient activity, trauma, or other biomechanical considerations (i.e., sitting on a low chair or stool).
  • Peripheral neuropathies, nerve damage, pain, circulatory compromise and heterotopic bone formation may occur.
  • Acetabular pain or perforation may occur due to device loosening.
  • Early or late loosening of the prosthetic components may occur.
  • Fatigue fracture of the femoral stem has been reported following total hip arthroplasty.
  • Early or late infection can occur.
  • Tissue reactions, osteolysis, and/or implant loosening have been reported. The causes may be related to metallic corrosion, metal sensitivity reactions, or the accumulation of polyethylene debris.
  • Delayed wound healing.
  • Damage to blood vessels or hematoma.
  • Cardiovascular disorders, including venous thrombosis, pulmonary embolism, or myocardial infarction.
  • Periarticular calcification or heterotopic ossification with or without impediment to joint mobility.
  • Trochanteric nonunion due to inadequate reattachment or early weight bearing.
  • Trochanteric avulsion, the result of excessive muscular tension, or early weight bearing.
  • Inadequate range of motion due to improper selection or positioning of components, femoral impingement, or periarticular calcification.
  • Femoral fracture while seating the device, by trauma, or excessive loading.
  • Leg length discrepancies.
Patient Information
  • Surgeons may wish to advise patients about the limitations of the total hip replacement and the need to protect the device from full weight bearing until adequate healing has occurred.
  • Dental procedures, endoscopic examinations, and other minor surgical procedures have been associated with transient bacteremia. Instruct patients to inform their doctors or dentists that they have a total hip replacement. The practitioners may wish to provide antibiotic cover for such procedures.
  • Surgeons should warn the patient about surgical risks and possible adverse effects.

Please contact ICONACY at +1 (574) 269-4266, if you have additional questions.

Storage

All implants must be stored in a clean, dry environment and protected from sunlight and temperature extremes.

Caution

Federal law (U.S.) restricts this device to sale by the order of a physician

i-Hip™ GT Femoral Stem Surgical Technique

Device Indicators For Use

The ICONACY™ i-Hip™ Total Hip Replacement is indicated for the following conditions:

  1. A severely painful and/or disabled hip joint as a result of osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
  2. Avascular necrosis of the femoral head.
  3. Acute traumatic fracture of the femoral head or neck.
  4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
  5. Certain cases of ankylosis.
  6. Nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques

The ICONACY™ i-Hip™ system consists of femoral stem and acetabular cup (i.e., shell) porous coated components intended for cementless, press-fit fixation.

Refer to the Package Insert for the list of contraindications.

This device is only available for commercial distribution in the United States.

*The ICONACY™ i-Hip™ system is comprised of the i-Hip™, i-Hip™ RS, and i-Hip™ GT.

General Description of Implant

The ICONACY i-Hip™ GT Femoral Stem System consists of a collarless, tapered, titanium alloy femoral stem mated to a Co-Cr alloy or ceramic modular femoral head. The i-Hip™ GT Femoral Stem System articulates with the acetabular device assembly in the ICONACY i-Hip™ and i-Hip™ RS Acetabular Cup Systems.

The i-Hip™ GT Femoral Stem Implant (i.e., stem) is made of forged Ti-6Al-4V ELI alloy. The stem is a double taper design. When viewed in the in situ position, the stem has a slight symmetrical taper, proximal to distal, in the sagittal plane, and a basically symmetrical taper, proximal to distal, in the coronal plane, ending in a rounded tip. 

The proximal lateral edge is curved, rather than straight, to allow the stem to clear the bony base of the greater trochanter of the femur during insertion.

The proximal 40% of the stem body is circumferentially porous coated with titanium plasma spray to attain cementless, press-fit fixation. The distal 60% of the stem body has a smooth, satin finish.

Stem lengths vary with stem size, ranging from 110mm to 132mm. The stem sizes, measured at the stem width in the coronal plane at a point approximately 91mm distal from the stem proximal shoulder, range from 8mm to 21mm, resulting in twelve stem sizes.

The stems are available in three varieties of femoral necks, a standard, a lateral, and reduced lateral. The lateral design provides an additional 6mm of lateralized offset for the femoral heads. The reduced lateral provides a reduction of 6mm of horizontal offset.

*Available in Reduced Lateral Stems

The stem necks have a standard 12/14 taper to accommodate the socket of the associated modular femoral heads.

The femoral heads are manufactured from wrought Co-Cr alloy or ceramic and are available in three head diameters: 28mm, 32mm and 36mm. The heads are available in five common neck lengths: -4mm, +0mm, +4mm, +8mm, and +12mm. The 32mm and 36mm are also available in -6mm. The femoral heads can be used on any i-Hip™ femoral stem for any of the associated neck length options.

The femoral Co-Cr heads have a color buff finish to minimize wear, with a surface finish of 0.05μm Max Ra. Ceramic 0.02. The heads have a 12/14 taper socket to mate with the taper of the femoral stems.

Preoperative Planning

Effective preoperative planning allows the surgeon to predict the impact of different interventions in order to perform the joint restoration in the most accurate and safe manner. Optimal femoral stem fit, the level of the femoral neck cut, the prosthetic neck length, and the femoral component offset can be evaluated through preoperative radiographic analysis. Preoperative planning also allows the surgeon to have the appropriate implants available at surgery.

The important parameters of preoperative planning include:

  • Determination of leg length
  • Establishment of appropriate abductor muscle tension and femoral offset
  • Determination of the anticipated component size

The overall objective of preoperative planning is to enable the surgeon to gather anatomic parameters which will allow accurate intraoperative placement of the femoral implant.

Determination of Leg Length

Determining the preoperative leg length is essential for restoration of the appropriate leg length during surgery. If there are concerns regarding lower extremity or lumbar abnormalities, such as equinus of the foot, flexion or varus/valgus deformities of the knee, or scoliosis, perform further radiographic evaluation to aid in the determination of preoperative leg length status.

An anterior/posterior (A/P) pelvic radiograph often gives enough documentation of leg length inequality to proceed with surgery. If more information is needed, a scanogram or CT evaluation of leg length may be helpful. From the clinical and radiographic information on leg lengths, determine the appropriate correction, if any, to be achieved during surgery.

If the limb is to be significantly shortened, osteotomy and advancement of the greater trochanter or a subtrochanteric shortening osteotomy may be necessary. If the limb is shortened without osteotomy and advancement of the greater trochanter, the abductors will be lax postoperatively, and the risk of dislocation will be high. Also, gait will be compromised by the laxity of the abductors. If leg length is to be maintained or increased, it is usually possible to perform the operation successfully without osteotomy of the greater trochanter. However, if there is some major anatomic abnormality, osteotomy of the greater trochanter may be helpful.

Establishment of Appropriate Abductor Muscle Tension and Femoral Offset

Once the requirements for establishing the desired postoperative leg length have been decided, the next step is to consider the requirement for abductor muscle tension. When templating, center the femoral component in the canal. Choose the offset (i.e., Standard, Lateral or Reduced Lateral) that most closely approximates that of the patient when the new center of rotation is determined (after acetabular component templating). For patients with a very large distance between the center of rotation of the femoral head and the line that is centered in the medullary canal, insertion of a femoral component with a lesser offset will medialize the femoral shaft. To the extent that this occurs, laxity in the abductors will result with a heightened dislocation risk.

Although rare, it may not be possible to restore offset in patients with an unusually large preoperative offset or with a severe varus deformity. In such cases, tension in the abductors can be increased by lengthening the limb, a method that is especially useful when the involved hip is short. If this option is not advisable and if the disparity is great between the preoperative offset and the offset achieved at surgery by using the longest head/neck piece possible, some surgeons may choose to osteotomize and advance the greater trochanter to eliminate the slack in the abductor muscles. Technical variations in the placement of the acetabular components can also reduce the differences in offset.

Determination of the Anticipated Component Size

Preoperative planning for insertion of a cementless femoral component requires at least two radiographic views of the involved femur: an A/P view of the pelvis centered at the pubic symphysis, and a frog leg lateral view on an 11×17-inch cassette. Both views should show at least 8 inches of the proximal femur. In addition, it may be helpful to obtain an A/P view of the involved side with the femur internally rotated. This compensates for naturally occurring femoral anteversion and provides a more accurate representation of the true medial-to- lateral dimension of the metaphysis. When templating, magnification of the femur will vary depending on the distance from the x-ray source to the film, and the distance from the patient to the film. Magnification markers can be used to identify the actual magnification of the radiograph. Knowing this will help to more accurately predict the component size when templating.

Templating the Femoral Stem

The objectives in templating the stem include determining the anticipated size of the implant to be inserted and the location of the femoral neck osteotomy.

To estimate the femoral implant size, assess the body size on the A/P radiograph. Superimpose the template on the metaphysis and estimate the appropriate size of the stem. The body of the stem should fit, or nearly fit, the medial-lateral dimensions of the medullary canal on the A/P x-ray film, and should not be superimposed onto cortical bone.

After establishing the proper size of the stem, determine the height of its position in the proximal femur and the amount of offset needed to provide adequate abductor muscle tension. Generally, if the leg length and offset are to remain unchanged, the center of the head of the prosthesis should be at the same level as the center of the femoral head of the patient’s hip. This should also correspond to the center of rotation of the templated acetabulum. To lengthen the limb, raise the template proximally. To shorten the limb, shift the template distally. The lateral offset option offers lateral translation of 6mm. This allows for an offset increase of 6mm without changing the vertical height or leg length. The femoral head neck length will also affect leg length and offset.

Once the height has been determined, note the distance in millimeters from the underside of the osteotomy line to the top of the lesser trochanter by using the millimeter scale on the template. For example, one might decide from the templating that a 52mm O.D. cup, with a size 15 femoral stem and a 28mm femoral head, placed 15mm above the lesser trochanter, are the appropriate choices. Proximal/distal adjustments in prosthesis position reduce the need for a femoral head with a skirt.

Preparation of the Femur

It is crucial to adequately visualize the proximal femur so the correct insertion site for the femoral instruments can be located. Refer to the preoperative planning at this point.

The level of neck resection is determined during preoperative templating. Although specific to each patient, the neck cut often will be approximately 1cm above the lesser trochanter. Perform the neck osteotomy, taking care to maintain the desired angle.

Identify the mid-femoral shaft extension intraoperatively as viewed on the A/P and lateral radiographs. This is usually in the area of the piriformis tendon insertion in the junction between the medial trochanter and lateral femoral neck. Use the One-Piece Box Osteotome to remove this medial portion of the greater trochanter and lateral femoral neck.

The opening must be large enough for the passage of each sequential rasp to help ensure neutral rasp/implant alignment. An insufficient opening may result in varus stem positioning. Use the Rat-Tailed Rasp to remove additional bone from the base of the greater trochanter and to help avoid varus stem positioning.

After removing the cortical bone, use the smallest Femoral Stem Rasp to open the medullary canal. This will provide a reference for the direction of the subsequent femoral rasping.

Femoral Rasping

If planning to use the Calcar Planer, start rasping with the size 8 Rasp. (NOTE: The Calcar Planer can only be used with the size 8 Rasp). If the Calcar Planer will not be used, begin the rasping sequence with a GT Femoral Stem Rasp that is at least two sizes smaller than the estimated implant size. Advance in 1 or 2 size increments until the desired fit and stability is achieved. When inserting the rasp, be sure that it advances with each strike of the mallet. If the rasp can be seated at least 5mm below the osteotomy, progress to the next rasp size and repeat until the predicted final rasp size has been seated.

NOTE: Before using the next size rasp, be sure that the opening is large enough. If it is not, use the one-piece box osteotome or previous rasp again. The opening should not be significantly larger than the rasp or implant

If the predicted final rasp size can be countersunk more than 5mm and adequate cancellous bone is available in the metaphysis region (including the medial calcar), progress to the next larger rasp size after ensuring that there is sufficient room in the distal medullary canal.

The rasps and corresponding implants are sized such that a press-fit is created proximally. The plasma sprayed surface of the implant is slightly proud as compared to the surface. Thus, the implant is more than 1mm larger than the rasp in both the A/P and M/L dimensions. This relationship can be seen on the templates.

NOTE: The metaphyseal press-fit engagement provides the implant with greater rotational stability than the rasp.

Femoral Trialing Reduction

Verify the etched size on the rasp and trials before performing a trial reduction. GT Modular Neck Trials and Femoral Head Trials are available to assess proper component position, joint stability, range of motion, and leg length.

NOTE: For Standard offset, utilize the SILVER-colored Modular Neck Trials that are marked “STD”. For Lateral offset, utilize the BLACK-colored Modular Neck Trials that are marked “LAT”. For Reduced Lateral, utilize the GOLD-colored Modular Neck Trials that are marked “RED”.

Once the acetabular cup implant and Acetabular Trial Insert are also in place, you can perform a trial reduction of the construct.

Check the leg length and offset of the femur by referencing the lengths measured prior to dislocation of the hip. It is important at this stage to reposition the leg exactly where it was during the first measurement. Adjust the neck length by changing the Femoral Head Trial to achieve the desired result.

NOTE: When changing the head trials from the neck trial, apply a twisting motion to the head trial, while pulling axially.

Remove all of the trial components when trial reduction is complete.

Insertion of the Femoral Stem

Insert the femoral stem implant into the canal until it will no longer advance with hand pressure, which is approximately 1mm to 2mm above the final seated position. The Threaded Femoral Stem Inserter is threaded to allow the surgeon to control the femoral stem implant during insertion. A GT Femoral Stem Inserter is also available to allow some rotational freedom during insertion. The threaded insertion hole on the implant will accept either Femoral Stem Inserter.

NOTE: To reduce the potential for fracture, allow the femoral stem implant to follow the prepared envelope.

Apply the selected Femoral Stem Inserter to the femoral stem implant and begin to tap the handle with a mallet until the implant will no longer advance.

NOTE: Do not continue to try to advance the prosthesis once it has made contact with the cortical bone in the medial calcar.

The prosthesis should be seated when the most proximal part of the plasma sprayed surface is level with the osteotomy line. If the implant does not advance with each strike of the mallet, stop insertion. If the stem is too proud, consider removing the component. Rasp additional bone from the areas that are preventing the insertion and insert the femoral stem implant again.

Femoral Head Impaction

Following the implantation of the femoral stem, as well as the acetabular cup and poly liner, it is necessary to impact the head onto the stem taper.

Irrigate, clean, and dry the femoral stem to ensure the taper is free of debris. Before reducing the hip, place the appropriate femoral head onto the taper and tap using the Universal Femoral Head Impactor.

Once the entire construct is implanted, perform a final reduction to assess and confirm range of motion, hip stability, and limb length.

i-Hip™ RS Acetabular Cup Surgical Technique

i-Hip RS Acetabular Cup

Device Indicators For Use

The ICONACY i-hip total hip replacement is indicated for the following conditions:

  1. A severely painful and/or disabled hip joint as a result of osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
  2. Avascular necrosis of the femoral head.
  3. Acute traumatic fracture of the femoral head or neck.
  4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
  5. Certain cases of ankylosis.
  6. Nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The ICONACY™ i-Hip™ System consists of femoral stem and acetabular cup (i.e., shell) porous coated components intended for cementless, press-fit fixation.

Refer to the Package Insert for the list of contraindications.

This device is only available for commercial distribution in the United States.

Preoperative Planning

Accurate preoperative planning and acetabular templating are essential in choosing the correct acetabular cup and poly liner, and in providing an estimation of the range of acetabular components that might ultimately be required.

The important parameters of preoperative planning include:

  • Planned optimal position of the acetabular cup
  • Center of rotation
  • Size of the implant
  • Depth
  • Final component position
  • Achieving the recommended abduction angle

Templates of the cup and poly liner are available for preoperative planning). It is necessary to combine these templates with that of the chosen i-Hip™ femoral stem and femoral head by making the centers of rotation correspond.

The final size of the prosthesis is determined during the surgical procedure. When templating, it is important to establish the planned optimal position of the acetabular cup, center of rotation, size of the implant, depth, and final component position.

Cup position and size are determined using template overlays on the a/p radiograph of the hip. Superimpose the cup templates sequentially on the pelvic radiograph with the cup in approximately 40 degrees of abduction. Range of motion and stability are optimized when the cup is placed in approximately 35 to 45 degrees of abduction. Assess several sizes to estimate which cup will provide the best fit for maximum coverage.

The acetabular teardrop can be used as the inferior- medial margin reference point for the acetabular reconstruction. Once the cup position, size, and poly liner are determined, the intended center of rotation of the bearing surface should be marked on the a/p radiograph. Achieving an abduction angle to a maximum of 45 degrees, and 10 degrees to a maximum of 20 degrees of anteversion angle, is appropriate in most cases. Variation in placement of the cup will depend on the patient’s anatomy and intraoperative surgical judgement.

General Description of Implant

The ICONACY i-Hip™ RS acetabular cup System consists of a hemispherical titanium alloy acetabular cup (i.e., shell) mated with a highly cross-linked ultra- high molecular weight polyethylene (i.e., poly) liner that is locked into the cup with a ring. The i-Hip™ RS acetabular cup System articulates with the femoral stem device assembly in the ICONACY™ i-Hip™ Femoral Stem System.

The i-Hip™ RS cup implant (i.e., cup) is machined from forged Ti-6Al-4V ELI alloy. The cup is provided in sizes 46mm to 64mm, in 2mm increments. The cup has a threaded, central polar hole to mate with a threaded insertion tool. The cup is available with two, peripheral screw holes to permit the use of bone screws for adjunct fixation. The finned cup does not have peripheral screw holes.

The outer hemispherical surface of the cup has a porous coated, titanium plasma spray for cementless, press-fit fixation. The inner surface of the cup has a very smooth surface (0.8μm Max Ra) to minimize the possibility of wear between the inner surface of the cup and the hXl UHMWPE poly liner.

A titanium alloy cup locking ring is fixed in a locking groove at the inner surface of the shell, near the periphery or mouth of the shell. The cup locking ring will engage the groove in the hXL UHMWPE poly liner to lock it into the cup.

The poly liner has a smoothly finished outer surface to seat with the smooth inner surface of the cup for the associated, compatible sizes. The articulating surface of the poly liner is smoothly finished (0.4μm Max Ra) to minimize wear when coupled with the polished femoral heads. The poly liners have a series of lugs that mate with similar recesses at the mouth of the cup so that the poly liner can resist rotational forces that may be applied to the acetabular device assembly.

Acetabular Reaming

Complete exposure of the acetabulum is essential to accurately prepare the bone and position of the implant.

Progressively ream the acetabulum, in 1mm to 2mm increments, with the acetabular Reamers until healthy, bleeding, cancellous bone is reached and a hemispherical dome is achieved.

NOTE: each surgeon’s approach may vary. The selected surgical approach must provide adequate exposure to visualize the entire acetabular rim. This will reduce the likelihood of soft tissue entrapment, which may prevent the cup from fully seating.

NOTE: In order to achieve a press-fit, surgical judgement and adequate bone stock are required to assess appropriate reaming. Press-fit is achieved by careful bone preparation and accurate implant placement.

NOTE: The true external diameter of the cup, including the porous coating, corresponds directly to the labeled size. A cup sized 2mm over the reamed preparation (size of last reamer used) will provide 2mm press-fit at the rim. A 1mm press-fit may be desired with hard bone.

Acetabular Cup Implant Insertion

Once the appropriate dome size has been achieved, assemble the proper size cup to the Acetabular Cup impactor handle. With the acetabular cup impactor handle tip placed, rotate the thumbwheel clockwise to thread and secure the implant to the assembly. the labeled outside diameter (O.D.) of the cup represents the true hemispherical diameter of the implant.

To assist with ensuring optimal cup positioning in abduction and anteversion intraoperatively, utilize the Acetabular Cup positioning guide by attaching it to the acetabular cup impactor handle. Range of motion and stability are optimized when the cup is placed in approximately 35 to 45 degrees of abduction. achieving an abduction angle to a maximum of 45 degrees, and 10 degrees to a maximum of 20 degrees of anteversion angle, is appropriate in most cases. Variation in placement of the cup will depend on the patient’s anatomy and intraoperative surgical judgement.

With the acetabular cup implant in the appropriate position and alignment, use a mallet to impact the acetabular cup impactor handle. When the cup implant is fully seated, remove the acetabular cup impactor handle. To assist with releasing the handle from the cup, utilizing the apex hole at the dome can assist in confirming that the cup is fully seated in the bone cavity.

NOTE: Uneven intraoperative tamping or impacting (i.e., adjustment) of the periphery of the cup is not recommended. If adjustment is necessary or unavoidable, please ensure the associate acetabular insert trial is inserted into the cup to protect cup locking ring.

Trial Insert Assessment and Reduction

Prior to poly liner implantation, it is important to assess proper component position, joint stability, range of motion, and leg length utilizing the Acetabular Insert trials.

Insert the appropriately sized Acetabular Insert Trial into the implanted acetabular cup by hand.

Once the final size Femoral Rasp, as well as the associated Modular Neck Trial and Femoral Head Trial are in place, perform a joint trial reduction.

Remove the Acetabular Insert Trial once the size has been selected and confirmed. If removal by hand is difficult, utilize the Liner Impactor Handle for extraction by threading it onto the acetabular insert trials, in situ.

Remove all of the trial components when trial reduction is complete.

Bone Screw Preparation and Placement (Optional)

If bone screw placement is desired, drill a pilot hole through the selected peripheral hole using the 3.2mm diameter Drill Bit on the Angled Drill Driver. The apex hole at the dome of the cup cannot be used for bone screw fixation.

Position the Drill Bit assembly through the Drill Guide and into the selected peripheral screw hole. Drill a screw hole and use the Depth Gauge to measure its depth.

Select the appropriate length 6.5mm diameter i-Hip™ Bone Screw. Use the Universal Joint Screw Driver to insert and seat the bone screw into the drilled hole.

After seating the bone screw, check to ensure that the head is below the inner diameter of the cup. place an additional bone screw if desired and permissible.

To remove a bone screw, engage the screw with the Universal Joint Screw Driver and turn counterclockwise.

Poly Liner Insertion and Final Reduction

Prior to inserting the selected poly liner, ensure that the cup interior is clean and dry. place the poly liner into the implanted cup by hand and rotate the poly liner until the lugs are aligned for final engagement.

Select the proper sized Liner Impactor Head and attach it to the liner impactor handle. place the liner impactor on the poly liner and strike the liner until it is fully seated in the cup.

NOTE: For visual confirmation of poly liner locking, ensure that the locking ring eyelets have centered within the locking ring window. The locking ring eyelets should have zero to minimal gap relative to the center post. Neither locking ring eyelet should have any excessive gap relative to the center post.

Once the entire construct (i.e., i-Hip™ acetabular cup and Femoral Stem Systems) is implanted, perform a final reduction to assess and confirm range of motion, hip stability, and limb length.

Poly Liner Removal

If a poly liner requires removal intraoperatively, inspect the cup locking mechanism for damage. if necessary, the cup locking ring can be replaced independent of the entire cup implant.

In order to remove and extract the poly liner, move one eyelet clockwise, to release the pressure, then use the open chamfers to pry out the liner.

The stability of a new poly liner should be assessed through trial reduction.

Locking Ring Replacement

If the RS cup locking ring is damaged, remove and replace it with the appropriate size and type (i.e., RS locking ring. Replacement RS cup locking rings are provided separately.

Femoral Trialing Reduction

Verify the etched size on the rasp and trials before performing a trial reduction. GT Modular Neck Trials and Femoral Head Trials (Fig. 8) are available to assess proper component position, joint stability, range of motion, and leg length.

NOTE: For Standard offset, utilize the SILVER-colored Modular Neck Trials that are marked “STD”. For Lateral offset, utilize the BLACK-colored Modular Neck Trials that are marked “LAT”. For Reduced Lateral, utilize the GOLD-colored Modular Neck Trials that are marked “RED”.

Once the acetabular cup implant and Acetabular Trial Insert are also in place, you can perform a trial reduction of the construct.

Check the leg length and offset of the femur by referencing the lengths measured prior to dislocation of the hip. It is important at this stage to reposition the leg exactly where it was during the first measurement. Adjust the neck length by changing the Femoral Head Trial to achieve the desired result.

NOTE: When changing the head trials from the neck trial, apply a twisting motion to the head trial, while pulling axially.

Remove all of the trial components when trial reduction is complete.

Insertion of the Femoral Stem

Insert the femoral stem implant into the canal until it will no longer advance with hand pressure, which is approximately 1mm to 2mm above the final seated position (Fig. 9). The Threaded Femoral Stem Inserter is threaded to allow the surgeon to control the femoral stem implant during insertion. A GT Femoral Stem Inserter is also available to allow some rotational freedom during insertion. The threaded insertion hole on the implant will accept either Femoral Stem Inserter.

NOTE: To reduce the potential for fracture, allow the femoral stem implant to follow the prepared envelope.

Apply the selected Femoral Stem Inserter to the femoral stem implant and begin to tap the handle with a mallet until the implant will no longer advance (Fig. 10).

NOTE: Do not continue to try to advance the prosthesis once it has made contact with the cortical bone in the medial calcar.

The prosthesis should be seated when the most proximal part of the plasma sprayed surface is level with the osteotomy line. If the implant does not advance with each strike of the mallet, stop insertion. If the stem is too proud, consider removing the component. Rasp additional bone from the areas that are preventing the insertion and insert the femoral stem implant again.

Femoral Head Impaction

Following the implantation of the femoral stem, as well as the acetabular cup and poly liner, it is necessary to impact onto the taper of the stem

Irrigate, clean, and dry the femoral stem to ensure the taper is free of debris. Before reducing the hip, place the appropriate femoral head onto the taper and tap using the Universal Femoral Head Impactor (Fig. 11).

Once the entire construct is implanted, perform a final reduction to assess and confirm range of motion, hip stability, and limb length.