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PHX

Shoulder Prosthesis, Reverse Configuration

Product code
PHX
Device name
Shoulder Prosthesis, Reverse Configuration
Device class
Class 2
21 CFR
21 CFR 888.3660
Medical specialty
Orthopedic
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (last 3 years)
205

FDA classification definition

Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (38)

Last three years. Most recent: 2026-07-01.

NumberDecision dateApplicantDevice nameSummary
K2605562026-07-01Restor3DVeritas Shoulder SystemPDF
K2616832026-06-16Zimmer, Inc.Augment Off-Axis Instrument SystemPDF
K2601022026-06-12Stryker Corporation (Tornier, Inc.)Tornier Perform Reversed Glenoid and Tornier PerformFDA
K2610162026-06-10Medacta International, SAMSS - Humeral reverse liners extensionPDF
K2539922026-05-07Restor3DVeritas Reverse Total Shoulder SystemPDF
K2524042026-04-15Biomet OrthopedicsComprehensive Reverse Shoulder - HA Glenosphere BasePDF
K2605832026-04-14Exactech, Inc.Equinoxe® Shoulder SystemPDF
K2541282026-04-13Shoulder Innovations, Inc.InSet Reverse Total Shoulder SystemPDF
K2536742026-04-03Stryker Corporation (Tornier, S.A.S.)Blueprint Patient-Specific InstrumentationPDF
K2536242026-03-11Depuy Ireland UCINHANCE™ Reverse Shoulder SystemPDF
K2506442026-02-03Medacta International S.A.MSS - Monobloc stemPDF
K2523522026-01-22Lima Corporate S.P.A.SMR Shoulder System; PRIMA Glenoid System; PRIMA HumPDF
K2525672026-01-15Encore Medical L.P.AltiVate Reverse® ADLC GlenospherePDF
K2525162026-01-15Shoulder Innovations, Inc.N22 EZ GlenospherePDF
K2540032026-01-09FH IndustrieJARVIS Metaphyseal StemPDF
K2527882026-01-08Tornier, Inc.Tornier Perform™ Reversed Monopost Glenoid (Perform FDA
K2503382025-10-31Medacta International S.A.MSS - Humeral reverse liners extensionPDF
K2533452025-10-29FH IndustrieJARVIS Diaphyseal Stem StandardFDA
K2522212025-09-26Shoulder Innovations, Inc.Inset Reverse Total Shoulder SystemPDF
K2524112025-08-28FH IndustrieJARVIS Glenoid Reverse Shoulder ProsthesisPDF
K2521412025-08-05Encore Medical L.P.AltiVate Reverse® GlenoidPDF
K2434482025-08-01Exactech, Inc.Equinoxe® Shoulder SystemPDF
K2438262025-07-03Lima Corporate S.P.A.SMR Reverse HP Shoulder SystemPDF
K2436432025-05-19Restor3Drestor3d Reverse Total Shoulder Arthroplasty SystemPDF
K2511842025-05-16Encore Medical L.P.AltiVate Reverse Shoulder System; RSP Shoulder SysteFDA
K2422532024-11-25FH IndustrieJARVIS Glenoid Reverse Shoulder ProsthesisPDF
K2414912024-10-10Stryker Corporation (Tornier, S.A.S.)Blueprint Patient-Specific Instrumentation; ShoulderPDF
K2334822024-07-18Exactech, Inc.Equinoxe® Central Screw Baseplate SystemPDF
K2334812024-05-29Encore Medical L.P.AltiVate Reverse® GlenoidPDF
K2402782024-05-15Fx Shoulder USA, Inc.Full Wedge Lateralized and Augmented BaseplatesPDF
K2410432024-05-15Fix SurgicalAugment Off-Axis Instrument SystemPDF
K2341052024-04-05Catalyst Orthoscience, Inc.Catalyst F1x Shoulder SystemPDF
K2331482024-03-22Fix SurgicalAugment Off-Axis Instrument SystemFDA
K2322652024-02-21Tornier S.A.S.BLUEPRINT™ Patient Specific InstrumentationPDF
K2314452023-11-16Waldemar Link GmbH & Co. KGLINK Embrace Shoulder System - Reverse ConfigurationPDF
K2319112023-11-09Medacta International S.A.Glenoid Reconstruction System – Full Wedge BaseplatePDF
K2325832023-09-20Catalyst Orthoscience, Inc.Catalyst R1 Reverse Shoulder SystemPDF
K2238332023-09-14Exactech, Inc.Exactech® Equinoxe® Reverse Humeral Liners and HumerPDF

33 summaries are archived here for direct download.

Official FDA classification page: PHX
Classification and pathway per current FDA publications. Data from openFDA (CC0).