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The ATTUNE Cementless CR and PS Femoral Components are intended for cementless use within the ATTUNE total knee replacement system.

Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant (provided that adequate bone is present).

The ATTUNE Cementless cruciate retaining (CR) and posterior stabilized (PS) femoral components have an asymmetric trochlear groove and are available in sizes 1-10 in right and left options. Sizes 3-6 are available in standard and narrow options. The fixation surface is porous coated with Porocoat. The porous coated fixation surface comprises: the bone cut surfaces of the anterior flange, anterior chamfer, distal surface, posterior chamfer, posterior condylar resection, as well as the lugs for additional stability. The fixation of the femoral component to the femoral bone is achieved by biologic fixation via ingrowth into the Porocoat porous coating. The ATTUNE femoral components are manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75. The ATTUNE Cementless CR Femoral Components are compatible with the ATTUNE CR Fixed Bearing inserts (K101433), fixed bearing tibial bases (K101433), and patellae (K103756). The ATTUNE Cementless PS Femoral Components are compatible with the ATTUNE PS Fixed Bearing inserts (K111433), fixed bearing tibial bases (K101433), and patellae (K103756). The ATTUNE CR Total Knee is designed to accommodate knee flexion to 150 degrees in those patients able to attain a high degree of knee flexion. The ATTUNE PS Total Knee is designed to accommodate knee flexion to 145 degrees in those patients able to attain a high degree of knee flexion.

This document pertains to the 510(k) premarket notification for the ATTUNE® Knee System-Cementless CR and PS Femoral Components. It describes the device and its substantial equivalence to predicate devices, focusing on the lack of need for new studies rather than describing the acceptance criteria or studies of the device itself.

Based on the provided text, there is no information available regarding acceptance criteria or a study that proves the device meets those acceptance criteria for the ATTUNE® Knee System-Cementless CR and PS Femoral Components.

The document explicitly states:

• "Non-Clinical Testing: None provided as it was not necessary to determine substantial equivalence between the ATTUNE Cementless CR and PS Femoral Components and the predicate devices. As the coating for the subject device is identical to that in K062654, the characterization in K062654 also applies to this 510(k)." (Page 6)
• "Clinical Testing: None provided as it was not necessary to determine substantial equivalence between the ATTUNE Cementless CR and PS Femoral Components and the predicate devices." (Page 6)

The submission argues for substantial equivalence based on existing predicate devices:

• The ATTUNE Cementless CR and PS Femoral Components are "identical in design to the ATTUNE CR and PS Femoral Components cleared for cemented use only in K101433 and K111433."
• "The Porocoat porous coating of the ATTUNE Cementless CR and PS Femoral Components is identical to the Porocoat porous coating used on the SIGMA CR Porocoat Femoral Components cleared for Cementless use in K062654."

Therefore, I cannot provide the requested information from the given text as it explicitly states that new testing was not performed for this 510(k) submission.

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