FDA Product Code PHX: Shoulder Prosthesis, Reverse Configuration

FDA product code PHX covers reverse configuration shoulder prostheses.

Unlike anatomical shoulder replacements, reverse shoulder prostheses invert the ball-and-socket geometry — placing the ball on the glenoid side and the socket on the humeral side. This design relies on the deltoid muscle instead of the rotator cuff, making it the preferred solution for patients with massive rotator cuff tears or complex shoulder pathology.

PHX devices are Class II medical devices, regulated under 21 CFR 888.3660 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Exactech, Inc., Encore Medical, L.P. and Biomet Manufacturing Corp.