Identity Shoulder System

The Identity Shoulder System's Comprehensive Humeral Head Adapter (CHHA) is a shoulder joint prosthesis component designed for hemiarthroplasty and conventional total shoulder replacement. It treats non-inflammatory degenerative joint disease, rheumatoid arthritis, proximal humerus fractures, and rotator cuff deficiency by providing modular compatibility with previously cleared Identity Humeral Heads and Comprehensive humeral components.

The CHHA has identical intended use, indications, materials, and sterilization methods to predicate devices. Design features are similar to predicates, and packaging is identical. The device allows additional compatibility between the Identity Shoulder System's humeral heads and Comprehensive humeral components (excluding fracture stems).

Not stated in this summary.

The device achieves substantial equivalence because it is a line extension of the already-cleared Identity Shoulder System (K213856) with the same intended use and indications for use as the primary predicate. Non-clinical verifications confirmed fatigue, fretting corrosion, fixation stability, range of motion, modular junction strength, and MRI compatibility. The similar technological characteristics and identical materials, sterilization, and packaging to predicates demonstrate that any design differences do not raise different safety or effectiveness questions.