InSet Reverse Total Shoulder System

The InSet Reverse Total Shoulder System with InSet 135 Humeral Stem is a shoulder prosthesis designed for patients with a severely deficient rotator cuff and arthropathy, or those with previously failed shoulder replacement. It is indicated for primary, fracture, or revision total shoulder replacement to relieve pain and disability, and can treat proximal humerus fractures when adequate bone stock remains. The system comprises a glenoid baseplate (cementless with screw fixation) and a humeral stem (press-fit or cemented).

The InSet 135 Humeral Stem is a collarless, titanium alloy (Ti-6Al-4V ELI per ASTM F136) component with proximal porous coating of commercially pure titanium (ASTM F67) and fins for rotational stability. It represents a length variant of the previously cleared InSet 95 Humeral Stem, maintaining identical design features, material composition, surface characteristics, and taper interface. Differences in stem length, packaging, shelf-life, and manufacturing sites were evaluated through non-clinical testing.

ASTM F136 (titanium alloy specification), ASTM F67 (commercially pure titanium specification). Testing included mechanical evaluation with worst-case fatigue analysis, taper interface justification, sterilization validation, packaging validation, shelf-life testing, and pyrogen testing per applicable performance requirements.

The InSet 135 is substantially equivalent to the predicate InSet 95 because it maintains identical design features, materials, fixation methods, and sterilization across the same intended use and fundamental technology. The proposed fracture indication expansion is supported by the legally marketed INHANCE Reverse Shoulder System (K212737), cleared under the same regulation and product code. Non-clinical testing demonstrated that differences in stem length and other parameters do not raise different questions of safety or effectiveness.