SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System

The SMR Shoulder System and PRIMA Shoulder System are modular shoulder joint prostheses intended for partial or total, primary or revision shoulder replacement. They include anatomic and reverse configurations with various humeral stems, glenoid components, and liners made of titanium alloys, cobalt-chromium, and ultrahigh-molecular-weight polyethylene (UHMWPE). Both cemented and uncemented fixation options are available depending on component selection.

The subject devices feature an inversion of material compared to the primary predicate—polyethylene glenospheres articulating against cobalt-chromium reverse liners instead of the reverse arrangement. The subject devices are offered in a wider range of sizes, lateralization options, eccentricity, and angulation. Reference devices support safety and effectiveness evidence for larger diameters (>40 mm), lateralization, eccentricity, and angulation features.

ISO 5832-3 (Ti6Al4V), ISO 5832-12 (CoCrMo), ISO 5834-2 (UHMWPE), ASTM F1472, ASTM F1537, ASTM F648, ASTM F2695, ASTM F2565, ASTM F1580 (PoroTi coating), ISO 13782, ASTM F560 (Tantalum), ISO 10993-1 (biocompatibility), and ASTM F2028 (glenoid loosening evaluation).

The subject devices are substantially equivalent to the primary predicate (K243826) based on identical intended use, indications for use, principles of operation, and performance features. Mechanical testing including fatigue, push-out, wear, particle analysis, range of motion, and liner retention tests demonstrated equivalent performance. Biological safety evaluation and previously validated sterility and shelf-life data from the predicate system support substantial equivalence, and reference devices provide additional evidence for extended size and feature ranges.