ClearanceBrief
Panels › Orthopedic › Product code PHX · Class 2

Shoulder Prosthesis, Reverse Configuration

Regulation 888.3660

18510(k)s in 12 months (207 all time)
11recalls in 12 months (68 all time)
68recalls that name a 510(k)
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Top companies in PHX

Company510(k)sRecalls
Exactech, Inc.2123
Encore Medical L.P.1816
Tornier183
Biomet Manufacturing Corp150
Zimmer GmbH105
DePuy Orthopaedics, Inc.68
Medacta International S.A.130
Arthrex, Inc.110
Lima Corporate S.P.A.110
Biomet Corporation46
Decided510(k)Device and applicantCode
Oct 22, 2026K263421Veritas Shoulder System
restor3d, inc.
PHX
Oct 2, 2026K263086AltiVate Reverse® Glenosphere with RAVN™ Technology
Encore Medical L.P.
PHX
Jul 1, 2026K260556Veritas Shoulder System
Restor3D
PHX
Jun 16, 2026K261683Augment Off-Axis Instrument System
Zimmer, Inc.
PHX
Jun 12, 2026K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System
Stryker Corporation (Tornier, Inc.)
PHX
Jun 10, 2026K261016MSS - Humeral reverse liners extension
Medacta International, SA, CH
PHX
May 7, 2026K253992Veritas Reverse Total Shoulder System
Restor3D
PHX
Apr 15, 2026K252404Comprehensive Reverse Shoulder - HA Glenosphere Baseplates
Biomet Orthopedics
PHX
Apr 14, 2026K260583Equinoxe® Shoulder System
Exactech, Inc.
PHX
Apr 13, 2026K254128InSet Reverse Total Shoulder System
Shoulder Innovations, Inc.
PHX
Apr 3, 2026K253674Blueprint Patient-Specific Instrumentation
Stryker Corporation (Tornier, S.A.S.), FR
PHX
Mar 11, 2026K253624INHANCE™ Reverse Shoulder System
Depuy Ireland UC, IE
PHX
Feb 3, 2026K250644MSS - Monobloc stem
Medacta International S.A., CH
PHX
Jan 22, 2026K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System
Lima Corporate S.P.A., IT
PHX
Jan 15, 2026K252567AltiVate Reverse® ADLC Glenosphere
Encore Medical L.P.
PHX
Jan 15, 2026K252516N22 EZ Glenosphere
Shoulder Innovations, Inc.
PHX
Jan 9, 2026K254003JARVIS Metaphyseal Stem
FH Industrie, FR
PHX
Jan 8, 2026K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)
Tornier, Inc.
PHX
Oct 31, 2025K250338MSS - Humeral reverse liners extension
Medacta International S.A., CH
PHX
Oct 29, 2025K253345JARVIS Diaphyseal Stem Standard
FH Industrie, FR
PHX
Sep 26, 2025K252221Inset Reverse Total Shoulder System
Shoulder Innovations, Inc.
PHX
Aug 28, 2025K252411JARVIS Glenoid Reverse Shoulder Prosthesis
FH Industrie, FR
PHX
Aug 5, 2025K252141AltiVate Reverse® Glenoid
Encore Medical L.P.
PHX
Aug 1, 2025K243448Equinoxe® Shoulder System
Exactech, Inc.
PHX
Jul 3, 2025K243826SMR Reverse HP Shoulder System
Lima Corporate S.P.A., IT
PHX
May 19, 2025K243643restor3d Reverse Total Shoulder Arthroplasty System
Restor3D
PHX
May 16, 2025K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System
Encore Medical L.P.
PHX
Nov 25, 2024K242253JARVIS Glenoid Reverse Shoulder Prosthesis
FH Industrie, FR
PHX
Oct 10, 2024K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid
Stryker Corporation (Tornier, S.A.S.), FR
PHX
Jul 18, 2024K233482Equinoxe® Central Screw Baseplate System
Exactech, Inc.
PHX
May 29, 2024K233481AltiVate Reverse® Glenoid
Encore Medical L.P.
PHX
May 15, 2024K241043Augment Off-Axis Instrument System
Fix Surgical
PHX
May 15, 2024K240278Full Wedge Lateralized and Augmented Baseplates
Fx Shoulder USA, Inc.
PHX
Apr 5, 2024K234105Catalyst F1x Shoulder System
Catalyst Orthoscience, Inc.
PHX
Mar 22, 2024K233148Augment Off-Axis Instrument System
Fix Surgical
PHX
Feb 21, 2024K232265BLUEPRINT™ Patient Specific Instrumentation
Tornier S.A.S., FR
PHX
Nov 16, 2023K231445LINK Embrace Shoulder System - Reverse Configuration
Waldemar Link GmbH & Co. KG, DE
PHX
Nov 9, 2023K231911Glenoid Reconstruction System – Full Wedge Baseplate
Medacta International S.A., CH
PHX
Sep 20, 2023K232583Catalyst R1 Reverse Shoulder System
Catalyst Orthoscience, Inc.
PHX
Sep 14, 2023K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays
Exactech, Inc.
PHX
Aug 29, 2023K232226ARROW Off-Centred Humeral Insert
FH Industrie, FR
PHX
Jun 5, 2023K223801FX V135(TM) Shoulder Prosthesis
Fx Shoulder USA, Inc.
PHX
May 9, 2023K223655Catalyst R1 Reverse Shoulder System
Catalyst Orthoscience, Inc.
PHX
Apr 10, 2023K230366Arthrex Univers Revers Monoblock Stem Size 4/33
Arthrex, Inc.
PHX
Mar 15, 2023K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System
Biomet Manufacturing Corp
PHX
Dec 2, 2022K223211INHANCETM Shoulder System – Humeral Stems and Stemless
Depuy Ireland UC, IE
PHX
Nov 23, 2022K213459Glenoid Reconstruction System
Medacta International S.A., CH
PHX
Nov 7, 2022K222936Humeris® 135 Shoulder System
Fx Shoulder USA, Inc.
PHX
Oct 14, 2022K220914Tornier Perform Humeral System – Fracture
Tornier, Inc.
PHX
Aug 31, 2022K221467INHANCETM Reverse Glenoid Peripheral Posts
Depuy Ireland UC, IE
PHX

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