PHX · Class II · 21 CFR 888.3660

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.

205
Total
205
Cleared
142d
Avg days
2003
Since
205 devices
145–168 of 205
Cleared Oct 08, 2013
COMPREHENSIVE REVERSE SHOULDER - TITANIUM GLENOSPHERE
K131353
Biomet Manufacturing Corp
Orthopedic · 151d
Cleared Sep 06, 2013
COMPREHENSIVE REVERSE SHOULDER SCREWS
K132239
Biomet Manufacturing Corp
Orthopedic · 50d
Cleared Jul 03, 2013
EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID BASEPLATE - LEFT & RIGHT
K131575
Exactech, Inc.
Orthopedic · 33d
Cleared May 09, 2013
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
K130661
Zimmer, Inc.
Orthopedic · 58d
Cleared Dec 06, 2012
EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR PLATE
K121067
Exactech, Inc.
Orthopedic · 244d
Cleared Dec 03, 2012
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, NON-POROUS HUMERAL STEMS
K122692
Zimmer, Inc.
Orthopedic · 90d
Cleared Sep 06, 2012
DEPUY CTA REVERSE SHOULDER SYSTEM
K122442
Depuy France
Orthopedic · 27d
Cleared Jul 26, 2012
COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS
K121183
Biomet Corporation
Orthopedic · 99d
Cleared Jul 12, 2012
ARROW REVERSE SHOULDER SYSTEM
K112193
Fournitures Hospitalieres Industrie
Orthopedic · 349d
Cleared Jul 09, 2012
SEVIIN REVERSE SHOULDER
K120374
Ingen Orthopedics, LLC
Orthopedic · 154d
Cleared Jul 05, 2012
AEQUALIS ADJUSTABLE MODULAR REVERSE SHOULDER SYSTEM
K120739
Tornier, Inc.
Orthopedic · 115d
Cleared Jun 11, 2012
DEPUT DELTA XTEND REVERSE SHOULDER
K120174
Depuy France
Orthopedic · 143d
Cleared Mar 13, 2012
AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS
K112144
Tornier
Orthopedic · 231d
Cleared Feb 24, 2012
SMR MODULAR GLENOID-METAL-BACK SMR MODULAR GLENOID-LINER SMR MODULAR GLENOID-BONE SCREWS
K113254
Lima Corporate S.P.A.
Orthopedic · 113d
Cleared Feb 16, 2012
COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE
K120121
Biomet, Inc.
Orthopedic · 30d
Cleared Jan 11, 2012
COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY
K113069
Biomet Manufacturing Corp
Orthopedic · 86d
Cleared Dec 20, 2011
LIMACORPORATE SMR REVERSE SHOULDER SYSTEM
K113523
Lima Corporate S.P.A.
Orthopedic · 21d
Cleared Dec 16, 2011
COMPREHENSIVE REVERSE SHOULDER
K113121
Biomet Manufacturing, Inc.
Orthopedic · 56d
Cleared Nov 15, 2011
RSP GLENOID BASEPLATE POROUS COATED
K112069
Encore Medical, L.P.
Orthopedic · 118d
Cleared Oct 28, 2011
DUOCENTRIC REVERSED
K103251
Aston Medical
Orthopedic · 359d
Cleared Oct 11, 2011
AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM
K112615
Tornier, Inc.
Orthopedic · 33d
Cleared Oct 03, 2011
REVERSE SHOULDER PROSTHESIS MONOBLOCK HEMI ADAPTER
K111735
Encore Medical, L.P.
Orthopedic · 104d
Cleared Sep 16, 2011
TURON RSP SOCKET SHELL-NEUTRAL MODEL 508-02-000, TURON RSP SOCKET SHELL-OFFSET MODEL 508-02-001
K111629
Encore Medical, L.P.
Orthopedic · 95d
Cleared Aug 18, 2011
SMR REVERSE SHOULDER SYSTEM
K110598
Lima Corporate S.P.A.
Orthopedic · 169d