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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)
38
Summaries archived here
33 (direct download)
510(k) clearances (all years, FDA)
205 (all years; only the last 3 years are listed here)

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 Perform…FDA
K2610162026-06-10Medacta International, SAMSS - Humeral reverse liners extensionPDF
K2539922026-05-07Restor3DVeritas Reverse Total Shoulder SystemPDF
K2524042026-04-15Biomet OrthopedicsComprehensive Reverse Shoulder - HA Glenosphere Base…PDF
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 Hum…PDF
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 Syste…FDA
K2422532024-11-25FH IndustrieJARVIS Glenoid Reverse Shoulder ProsthesisPDF
K2414912024-10-10Stryker Corporation (Tornier, S.A.S.)Blueprint Patient-Specific Instrumentation; Shoulder…PDF
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 Humer…PDF

33 summaries are archived here for direct download.

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