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 Depuy Ireland UC, Medacta International S.A. and Lima Corporate S.P.A..
List of Shoulder Prosthesis, Reverse Configuration devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Shoulder Prosthesis, Reverse Configuration devices (product code PHX). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Orthopedic FDA review panel. Browse all Orthopedic devices →