AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System

This submission covers five reverse shoulder prosthesis systems (AltiVate Reverse®, RSP®, SMR, and PRIMA) used for reverse total shoulder arthroplasty in patients with grossly deficient rotator cuffs and severe arthropathy. The devices consist of humeral stems, glenoid baseplates, and articulating components made of titanium, cobalt-chromium, and ultra-high molecular weight polyethylene, intended for cemented or cementless fixation depending on the specific component.

The submission proposes no design or material changes to previously cleared devices. Instead, it updates labeling to reflect new cross-system compatibility configurations allowing AltiVate Reverse® humeral components to be used with SMR or PRIMA glenoid components (and vice versa) in compatible sizes. All components retain their original materials, manufacturing processes, sterilization, and intended use.

Material standards cited include ISO 5832-3 and ASTM F1472 for Ti6Al4V; ISO 5832-12 and ASTM F1537 for CoCrMo; ISO 5834-2 and ASTM F648 for UHMWPE; ISO 5834-2, ASTM F648, ASTM F2695, and ASTM F2565 for LimaVit (Vitamin E crosslinked UHMWPE); ASTM F1580 for PoroTi coating; and ISO 13782 and ASTM F560 for tantalum.

Substantial equivalence is established because there are no changes to design, materials, function, intended use, manufacturing, sterilization, or packaging of the individual devices. Performance testing including wear testing and range of motion analysis on the new cross-system combinations demonstrated that subject and predicate devices perform similarly and raise no different questions of safety and effectiveness. The submission is fundamentally a labeling update documenting compatibility between already-cleared components, not introduction of new device technology.