INHANCE™ Reverse Shoulder System

The INHANCE Reverse Shoulder System is a shoulder joint prosthesis consisting of a titanium alloy humeral stem, shell, cross-linked UHMWPE liner, cobalt-chromium glenosphere, titanium baseplate, screws, and augments. It is intended for primary, fracture, and revision total reverse shoulder replacement procedures in patients with gross rotator cuff deficiency who have a functional deltoid muscle, as well as for conversion from anatomic to reverse prosthesis.

The subject device adds a 10-degree inclination to the humeral liner compared to the predicate INHANCE liner (K212737). The humeral neck-shaft angles fall within the range of legally marketed predicate reverse shoulder systems. Materials, sterilization methods, and sterile packaging remain identical to the predicate device.

ASTM F1378 (Range of Motion); ASTM F2052, F2119, F2182, F2213 (MR safety); ISO 10993-1 (Biocompatibility); ISO 11137-1, ISO 11137-2 (Sterilization validation); ISO 11607-1, ISO 11607-2 (Packaging integrity); fatigue, wear, and geometric comparison testing.

The subject device is substantially equivalent because the 10-degree inclination modification is a minor technological difference with no impact on safety or performance. The humeral neck-shaft angles remain within the range of existing legally marketed predicate devices, intended use and principles of operation are unchanged, and non-clinical testing demonstrates equivalence to the predicate without raising different safety or performance questions.