Comprehensive Reverse Shoulder - HA Glenosphere Baseplates

The Comprehensive Reverse Shoulder - HA Glenosphere Baseplates is a shoulder joint replacement system designed for patients with severely deficient rotator cuff and severe arthropathy or failed prior shoulder replacement. It is indicated for primary, fracture, or revision reverse total shoulder replacement to relieve pain and disability in patients with grossly deficient rotator cuffs who have adequate deltoid muscle function.

The device features a reverse configuration with humeral trays, bearings, glenospheres, baseplates, and various screws. The key change from the predicate is the application of a dual Hydroxyapatite (HA) coating over a Ti6Al4V (titanium) substrate on the glenosphere baseplate components, intended for cementless applications with screw fixation. The baseplate substrate material and underlying PPS coating remain identical to the predicate device.

Testing performed included biocompatibility assessment, shelf-life study, and characterization analyses using worst-case thickness and NIST Standard Reference Material (SRM) 2910b. Analyses encompassed elemental analysis, phase analysis, Ca/P ratio analysis, FTIR infrared analysis, dissolution rate testing, microstructural evaluation, static tensile testing, and shear fatigue testing.

Substantial equivalence is established based on identical intended use and indications for use to the primary predicate (K193373), similar materials (identical substrate and underlying PPS coating; similar HA coating), identical design features and sterilization methods, and non-clinical testing demonstrating that the proposed dual HA/PPS coating of the glenosphere baseplate components meets all applicable acceptance criteria and establishes substantial equivalence.