AGILON® XO Shoulder Replacement System

The AGILON® XO Shoulder Replacement System is a modular shoulder replacement system designed for total or hemi (partial) shoulder replacement in adults with conditions such as osteoarthritis, avascular necrosis, post-traumatic arthritis, fractures, and rheumatoid arthritis. This submission specifically addresses new cancellous screws for use in total reverse shoulder replacement configurations.

The subject submission introduces new cancellous screws for fixation in reverse shoulder replacement using previously cleared K231657 components (humeral heads, glenoids, glenospheres, stems, and metaphyseal components). Titanium alloy stems are designed for cementless fixation, while polyethylene glenoids are available for cemented fixation or cementless use with screw fixation. No changes were made to packaging, sterility, shelf life, or materials.

ASTM F543 testing was performed on the new cancellous screws, evaluating torsional properties, driving torque, and axial pull-out strength. Biocompatibility evaluation was completed per ISO 10993-1. Cleaning, sterilization, packaging, shelf-life, and endotoxin testing were leveraged from the predicate device K231657.

Engineering analysis and review of predicate testing showed no new worst-case scenarios requiring additional construct testing. The new cancellous screws met predetermined acceptance criteria and demonstrated sufficient performance for intended use per ASTM F543. Because the screws are used with previously cleared K231657 components with established safety and performance profiles, and the screws themselves met performance specifications, substantial equivalence is supported.