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The ATTUNE Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology are intended for cementless use within the ATTUNE® Total Knee Replacement System. Porous coated implants may be used with or without cement.

Candidates for total knee replacements with a severely painful and/or impaired knee function resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant (provided that adequate bone is present).

The ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology are compatible with the ATTUNE Knee System composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without porous coating. The tibial component may be comprised of a metal tibial base with or without porous coating, and a polyethylene insert and locking components, or be an all polyethylene device. The patella component may be of an all polyethylene design or a polyethylene patella with porous metal backing.

The ATTUNE Porous FB Tibial Base with AFFIXIUM 3DP Technology is manufactured from Titanium alloy (Ti-6Al-4V), available in sizes 1-10, and intended for cemented use within the ATTUNE Total Knee Replacement System. The bone apposing surfaces are comprised of 3D printed fixation features with a porous and solid geometry that enable biological fixation of the bone. The proximal surface is designed to work with currently available ATTUNE FB tibial inserts.

The ATTUNE Porous Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology are manufactured from 3D printed Titanium alloy (Ti-6Al-4V) substrate for the bone opposing surfaces with the articulation surface being produced from AOX ultra high molecular weight polyethylene (UHMWPE). The patellae are available in sizes 32, 35, 38, and 41mm and are intended for cementless or cemented use within the ATTUNE Total Knee Replacement System. The articular surface is designed to work with currently available ATTUNE Femoral Components.

This document is a 510(k) summary for the ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology. It outlines the device description, intended use, and comparative analysis with predicate devices to demonstrate substantial equivalence, rather than providing a study proving specific performance criteria for the device itself.

Therefore, the requested information regarding acceptance criteria and a study proving device performance in the context of an AI/human reader study (items 1-9) is not applicable to this document. This document pertains to the regulatory clearance of a medical implant, not an AI or diagnostic software.

However, based on the non-clinical tests performed to demonstrate substantial equivalence (as described on page 7), we can infer the types of performance aspects considered for regulatory approval of such a device:

The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section on page 7 lists the following tests performed:

• Peg Fatigue Testing for ATTUNE Cementless Patella
• Stryker Peg Fatigue Benchmark Testing for ATTUNE Cementless Patella
• Biocompatibility Evaluation Report (Patella)
• MRI Testing (Tibial Base & Patella)

These tests are designed to assess the safety and efficacy of the implant in terms of its mechanical properties, material compatibility with the human body, and compatibility with MRI imaging. The acceptance criteria for these tests would typically be defined by relevant ASTM or ISO standards for orthopedic implants, and the device would be considered to 'meet' these criteria if its performance falls within the established limits of these standards or is demonstrated to be equivalent to the predicate device.

No information regarding AI performance, human reader studies, or associated metrics like sensitivity, specificity, or effect sizes for AI assistance is present in this product clearance document.

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