INHANCE INTACT™

The INHANCE INTACT™ is a shoulder joint prosthesis system with a humeral stemless anchor designed for anatomic total shoulder replacement. It is used to treat osteoarthritis, post-traumatic arthritis, focal avascular necrosis of the humeral head, and previous shoulder surgeries that do not compromise fixation. The system includes individually packaged implants (humeral stemless anchor, humeral head, and glenoid components) and instruments for surgical placement.

The INHANCE INTACT™ instruments are newly designed compared to predicate device instruments but are intended to facilitate subscapularis-sparing total shoulder arthroplasty. The implant components themselves (humeral stemless anchor, humeral head, and glenoid components) are identical to those of the predicate device. The instruments have new design and specification compared to predicate instruments, though differences between systems do not raise different types of safety and effectiveness questions.

ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) was cited for biocompatibility assessment. The contact classification is Instrument, Bone/Tissue with limited duration (<24 hours).

The implant components are identical to the predicate device (Ignite Stemless Anatomic Shoulder System, K203108), ensuring equivalent safety and effectiveness profiles. Although the INHANCE INTACT™ instruments have new design specifications, biocompatibility testing and bench testing demonstrate design equivalence and material rationale equivalent to the predicate. The intended use, indications, and fixation methods remain unchanged. Non-clinical testing results show the subject devices have a safety and effectiveness profile equivalent to the predicate.