InSet Total Shoulder System

The InSet Total Shoulder System with InSet 95 Humeral Stem is a modular shoulder prosthesis for partial or total shoulder replacement. It treats degenerative, rheumatoid, or traumatic shoulder disease; humeral head fractures; proximal humerus fractures; avascular necrosis; and revision cases. The humeral stem may be used alone for hemiarthroplasty or combined with a glenoid component for total shoulder arthroplasty.

The InSet 95 Humeral Stem is collarless, manufactured from titanium alloy (ASTM F136) with fins for rotational stability, and features a porous commercially pure titanium coating (ASTM F1580) for biological fixation. It has a female Morse-type taper to interface with existing InSet modular humeral heads and supports both press-fit and cemented fixation, matching the predicate device's design and materials.

ASTM F136 (titanium alloy material specification) and ASTM F1580 (porous titanium coating specification). Non-clinical testing included cyclic fatigue testing to evaluate stem mechanical strength.

The InSet 95 Humeral Stem shares identical taper connection design, stem body contour, fixation methods, proximal porous coating material, and base materials with the predicate InSet Total Shoulder System humeral stems. Geometric modifications for fracture treatment do not raise new safety or effectiveness questions because the underlying design, materials, and mechanical properties remain substantially unchanged and have been validated through fatigue testing.