EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)

The EMPOWR Revision Knee™ Symmetric TT Cones are optional titanium implant accessories used in primary or revision total knee arthroplasty. They are sterile, single-use devices intended for skeletally mature patients with bone defects, poor bone quality, or sclerotic bone requiring supplemental fixation. The cones are fixed uncemented to bone and then cemented to the femoral and tibial implants.

The subject device has identical substrate material (Ti6Al4V alloy), size offerings, sterility, method of fixation, and cone-specific indications as the primary predicate. It differs in manufacturing process and coating, which are identical to the AMF TT Cones reference device—both use additive manufacturing via Electron Beam Melting with a porous Trabecular Titanium external surface. Packaging configuration is new but testing demonstrates it maintains sterility and product protection.

Dynamic Fatigue Testing per ASTM F1800-19e1 (modified); MR Conditional Labeling per ASTM F2052-21, ASTM F2213-17, ASTM F2119-07(2013), and ASTM F2182-10e2.

Substantial equivalence rests on identical substrate material, size, sterility, and fixation method compared to the primary predicate, combined with identical indications for use. Although manufacturing and coating differ from the primary predicate, these differences are identical to the AMF TT Cones reference device, which establishes a validated manufacturing pathway. Performance testing—dynamic fatigue and MR compatibility—demonstrates the subject device performs equivalently. No new safety or effectiveness issues are introduced by the changed manufacturing process or porous coating since both are proven technologies already in clinical use.