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 Tornier, Inc..
FDA 510(k) Cleared Shoulder Prosthesis, Reverse Configuration Devices (Product Code PHX)
About Product Code PHX - Regulatory Context
510(k) Submission Activity
200 total 510(k) submissions under product code PHX since 2003, with 200 receiving FDA clearance (average review time: 143 days).
Submission volume has increased in recent years - 26 submissions in the last 24 months compared to 19 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for PHX submissions have been consistent, averaging 139 days recently vs 144 days historically.
PHX devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →