restor3d Reverse Total Shoulder Arthroplasty System

The restor3d Reverse Total Shoulder Arthroplasty System is a shoulder replacement implant for patients with a deficient rotator cuff and functional deltoid muscle, indicated for primary, fracture, or revision surgery. The system consists of a glenoid baseplate, glenosphere, humeral stem, and polymer bearing component, along with supporting instruments and accessories.

The restor3d system is substantially equivalent to the predicate Zimmer Biomet Comprehensive Reverse Shoulder in intended use, indications, and performance specifications. The key difference is that restor3d uses additive manufacturing (3D printing) to create the glenoid baseplate and humeral stems with a porous surface, whereas the predicate uses traditional manufacturing methods.

ASTM F2028 (glenoid baseplate loosening), ASTM F2009 (Morse taper disassembly strength), ASTM F543 (bone screw testing), ASTM F1820 (poly liner performance), ASTM F1378 (range of motion analysis), plus fatigue, corrosion, and wear analyses.

The device shares the same intended use, indications for use, and performance specifications as the predicate Comprehensive Reverse Shoulder. Although the subject device uses additive manufacturing with a porous surface rather than conventional manufacturing, non-clinical bench testing across glenoid baseplate stability, humeral stem integrity, bearing performance, and range of motion demonstrates equivalent performance and does not raise different questions of safety or effectiveness compared to the predicate.