Equinoxe® Shoulder System

The Equinoxe Activit-E Humeral Liners are polymeric components used in reverse total shoulder arthroplasty (rTSA) as part of the Equinoxe Shoulder System. They are indicated for skeletally mature patients with degenerative glenohumeral joint diseases or fractures where joint replacement is the preferred treatment method.

The proposed device is constructed of highly crosslinked UHMWPE containing vitamin E (Activit-E), whereas the predicate device uses conventional UHMWPE. There are no proposed geometric or compatibility changes compared to the predicate humeral liner devices cleared in K223833. Both devices have identical design features and are provided sterile for single use.

ASTM F1877-24 (post-wear particle analysis), ISO 10993-1:2018 (biocompatibility), USP <161> and USP <85> (bacterial endotoxins), ANSI/AAMI ST72 (bacterial endotoxins), and ISO 13485 (quality management system requirements).

The proposed and predicate devices share identical indications for use, design features, and intended applications. Although the material differs (Activit-E versus conventional UHMWPE), both are biocompatible polymers with similar properties. Testing including fatigue, wear, particle analysis, and biocompatibility demonstrated that the material change does not alter safety or performance, establishing substantial equivalence to predicate K223833.