Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)

The Tornier Humeral Reconstruction System (Tornier HRS) and Tornier Perform Humeral System - Stem (Tornier PHS-Stem) are shoulder joint prostheses designed for total or partial replacement of the glenohumeral articulation. They are semi-constrained, metal/polymer cemented prostheses indicated for patients with intact or reconstructable rotator cuffs (anatomic configuration) or functional deltoid muscles (reverse configuration), treating conditions such as osteoarthritis, rheumatoid arthritis, fractures, and traumatic arthritis.

The Tornier HRS includes even-sized distal stem diameters, smaller monoblock stems, proximal body with 135-degree neck angle, humeral head couplers in three offset options, reversed tray sizes, and MR Conditional labeling. The Tornier PHS-Stem features expanded Vitamin E UHMWPE reversed inserts. Both systems use similar materials and design principles as the predicate Aequalis Flex Revive Shoulder System but with additional sizing options and design refinements.

Not stated in this summary.

The device is substantially equivalent because it has the same intended use, principle of operation, and technological classification as the predicate Aequalis Flex Revive Shoulder System (K191318). Non-clinical testing including fatigue, locking mechanism, pull-out/torque-out, wear, material characterization, biocompatibility, packaging, sterilization, and system compatibility testing demonstrated that design differences do not raise different safety or effectiveness questions. The differences in sizing, stem geometry, and humeral head couplers are technological refinements that maintain functional equivalence to the predicate.