Search Results

Biomet's APF Porous Coated Line Extension Prosthesis is intended for use in reconstruction of the hip joint due to damage caused by trauma or degenerative disease and in cases where a previous hip replacement component has failed. The device is intended for cemented application for general use and non-cemented application in skeletally mature individuals undergoing primary surgery for rehabilitating hip joints damaged as a result of non-inflammatory degenerative joint disease or any of its composite diagnosis. The device is a single use implant.

The device is composed of a metallic femoral stem (forged titanium) which is designed to articulate with a commercially available acetabular component. The APF Porous Coated Line Extension stem geometry is designed for proximal, as well as, distal stability and gradual offloading into the bone along the canal. The proximal portion of the stem incorporates a bi-planar taper to encourage proximal offloading, thus reducing stress shielding. This broad proximal geometry fills a greater portion of the metaphysis, thus providing improved rotational stability. In a cemented application, the increased proximal stress transfer of titanium helps preserve the calcar bone and maintain the integrity of the proximal cement mantle. The stem has a porous coated collar which is incorporated to provide the component stability and stress transfer. Only the underside of the collar is porous coated to help ensure collar-calcar contact and stress distribution. This also provides additional rotational stability and load transfer. Distally the stem is cylindrical with an anterior bow for left and right configurations. The distal anterior bow more closely matches the anatomic femur to provide rotational stability. This cylindrical design will also enhance implant stability by providing a potential area of biological fixation in situations of proximal bone deficiencies. The lower modulus of elasticity of a titanium stem will also produce less distal stress offloading and is less likely to fracture the cement mantle. The APF Porous Coated Line Extension stems will be 75%-100% porous coated to provide maximum proximal and distal fixation through tissue ingrowth in non-cemented applications or cement adherence in cemented applications. This circumferential closedpore porous coating potentially seals the the femur from debris migration. Porous coating on the underside of the collar along with extended proximal to distal porous coating, provide areas of potential tissue ingrowth in crucial regions of cortical bone. The roughened surface of the porous coating will also enhance the hip stem/cement bonding, thus improving the chances of long term success. The portion of the stem that is not porous coated (on the 75% and 80% porous coated components) has a 30 grit corse blast finish or (on the 100% porous coated components) the distal tip of the component has a bead blast finish. The femoral component utilizes a modular head which is taper-fit onto the stem at the time of surgery (Exhibit I). The modular heads are manufactured from wrought cobalt-chromium-molybdenum conforming to ASTM F-1537. The use of mixed metals in surgery is also addressed in MAF-153 (7/10/92 amendment, pg. 54-105). The stem trunions are identical to Biomet's Type I tapers for the Zirconia Ceramic Heads cleared in 510(k) K905687, K913420, and K925345. There is a 4 degree included angle on the trunion. Refer to Exhibit I for a complete listing of modular heads to be used with this stem. For more information on these modular heads, refer to MAF-442.

The provided text is a 510(k) summary for a medical device (APF Porous Coated Line Extension) seeking substantial equivalence to existing devices. It focuses on device description, intended use, and comparison to predicate devices, rather than presenting a study with specific acceptance criteria and performance data in the format requested.

Therefore, the information required to populate the table and answer the specific questions about acceptance criteria, study details, sample sizes, expert involvement, and ground truth is not available in the provided text.

The document discusses:

• Device Description: The physical characteristics and materials of the hip prosthesis.
• Intended Use: The medical conditions and patient populations for which the device is designed.
• Potential Risks: General risks associated with hip replacement surgery.
• Substantial Equivalence: A comparison of the device to other legally marketed hip stems (predicate devices). This is the primary method for demonstrating safety and effectiveness in a 510(k) submission, rather than presenting a de novo clinical study with specific acceptance criteria.

Based on the provided text, I cannot complete the requested tables and answer the questions. A 510(k) summary typically does not include the detailed study design, acceptance criteria, and performance metrics as would be found in a clinical study report or a different type of regulatory submission.

Ask a specific question about this device