SMR Reverse HP Shoulder System

The SMR Reverse HP Shoulder System is a shoulder joint prosthesis indicated for primary, fracture, or revision total shoulder replacement in patients with rotator cuff-deficient shoulders with severe arthropathy. The system uses modular components that can be assembled in various configurations for both cemented and uncemented use, and requires a functional deltoid muscle to operate effectively.

The key technological difference from the primary predicate is a reversal of bearing materials: the subject device uses crosslinked UHMWPE glenospheres paired with CoCrMo humeral liners, whereas the predicate SMR Shoulder System (K223876) uses CoCrMo glenospheres paired with UHMWPE humeral liners. Both devices share the same overall modular design, intended use, and fundamental reverse shoulder technology platform.

Testing was performed per ISO 10993-1 for biological safety evaluation. Material standards include ISO 5832-3, ASTM F1472 (Ti6Al4V), ISO 5832-12, ASTM F1537 (CoCrMo), ISO 5834-2, ASTM F648, ASTM F2695, ASTM F2565 (UHMWPE), ASTM F1580 (PoroTi), ISO13782, and ASTM F560 (Tantalum). Mechanical testing included fatigue, push-out, wear, creep/deformation, micromotion, particle analysis, and range of motion tests.

Substantial equivalence is based on the fact that the subject device shares identical intended use, overall design architecture, and modular platform with the predicate SMR Shoulder System (K223876). Although the bearing surface materials are reversed (UHMWPE glenosphere/CoCrMo liner vs. CoCrMo glenosphere/UHMWPE liner), reference devices (K112898, K100858) have already established safety and effectiveness for both UHMWPE components and UHMWPE/CoCrMo bearing surfaces. Mechanical and post-market clinical testing data from outside the US confirmed performance equivalent to predicates, supporting that the material swap does not create new safety or effectiveness concerns.