EMPHASYS Acetabular System

The EMPHASYS Acetabular System is a total hip replacement prosthesis consisting of porous-coated titanium alloy acetabular shells and polyethylene liners. It is used with compatible DePuy femoral stems and heads to replace damaged hip joints in patients with osteoarthritis, avascular necrosis, traumatic fracture, failed previous hip surgery, or ankylosis. The acetabular cups are indicated for cementless (uncemented) use only.

The subject devices include three additional porous-coated titanium alloy acetabular shells in a multi-hole configuration and ten corresponding AOX polyethylene acetabular liners in three configurations (Neutral, +4 Neutral, and ELV). These represent a line extension to the previously cleared EMPHASYS system with additional sizes, maintaining the same materials, geometry, and method of fixation as the predicate.

ASTM F1820-22 was used to test interconnection strength of shell and liner. The document indicates that worst-case analyses were performed for range of motion, deformation, impingement, unsupported shell fatigue, shell and liner thickness, articular clearance, wear, friction, and MRI safety, though specific test standards for these analyses are not detailed.

The EMPHASYS Acetabular System is substantially equivalent because it uses identical materials (porous titanium alloy shells and AOX polyethylene liners), maintains the same intended use and indications, employs the same method of fixation (uncemented), and operates under the same geometric principles as the predicate. Performance testing demonstrated no new worst-case scenarios, and interconnection strength testing confirmed equivalent performance to the predicate devices.