Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head

These are hip replacement prosthesis components (Evolve AP Cup, World Finned Cup, World G-Zero Liner, and Oddball Femoral Head) intended to replace a hip joint in patients with degenerative joint disease, inflammatory arthritis, bone fractures, or failed prior hip surgery. The devices are made from polyethylene, titanium, or cobalt-chromium materials and are used in total hip arthroplasty procedures.

The Evolve AP Cup is an all-polyethylene cemented acetabular cup identical to predicates in fixation method, shape, size, and material. The World Finned Cup is a cementless titanium cup with external fins for fixation, matching predicates in material, geometry, and coating. The World G-Zero Liner is a constrained polyethylene liner identical in modularity, material, and locking features. The Oddball Femoral Head is cobalt-chromium with the same taper connection and material as its predicate.

ISO 21535 (hip joint replacement implants), ASTM F1820 (modular acetabular device disassembly forces), ISO 7206-12 (acetabular shell deformation), and ASTM F3090 (acetabular device fatigue testing).

The subject devices have the same intended use and indications as their predicate devices. Minor technological differences do not raise new safety or effectiveness concerns. Non-clinical testing and engineering analysis demonstrate that the devices are mechanically and functionally equivalent to the predicate devices, supporting a determination of substantial equivalence.