FDA Product Code
FDA Product Code PHX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3660
510(k) Clearances — 206 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K263086 | AltiVate Reverse® Glenosphere with RAVN Technology | Encore Medical L.P. | 2026-10-02 | Special | PDF ↗ |
| K260556 | Veritas Shoulder System | Restor3D | 2026-07-01 | Traditional | PDF ↗ |
| K261683 | Augment Off-Axis Instrument System | Zimmer, Inc. | 2026-06-16 | Special | PDF ↗ |
| K260102 | Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System | Stryker Corporation (Tornier, Inc.) | 2026-06-12 | Traditional | PDF ↗ |
| K261016 | MSS - Humeral reverse liners extension | Medacta International, SA | 2026-06-10 | Traditional | PDF ↗ |
| K253992 | Veritas Reverse Total Shoulder System | Restor3D | 2026-05-07 | Traditional | PDF ↗ |
| K252404 | Comprehensive Reverse Shoulder - HA Glenosphere Baseplates | Biomet Orthopedics | 2026-04-15 | Traditional | PDF ↗ |
| K260583 | Equinoxe® Shoulder System | Exactech, Inc. | 2026-04-14 | Traditional | PDF ↗ |
| K254128 | InSet Reverse Total Shoulder System | Shoulder Innovations, Inc. | 2026-04-13 | Traditional | PDF ↗ |
| K253674 | Blueprint Patient-Specific Instrumentation | Stryker Corporation (Tornier, S.A.S.) | 2026-04-03 | Traditional | PDF ↗ |
| K253624 | INHANCE Reverse Shoulder System | Depuy Ireland UC | 2026-03-11 | Traditional | PDF ↗ |
| K250644 | MSS - Monobloc stem | Medacta International S.A. | 2026-02-03 | Traditional | PDF ↗ |
| K252352 | SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System | Lima Corporate S.P.A. | 2026-01-22 | Traditional | PDF ↗ |
| K252567 | AltiVate Reverse® ADLC Glenosphere | Encore Medical L.P. | 2026-01-15 | Traditional | PDF ↗ |
| K252516 | N22 EZ Glenosphere | Shoulder Innovations, Inc. | 2026-01-15 | Traditional | PDF ↗ |
| K254003 | JARVIS Metaphyseal Stem | FH Industrie | 2026-01-09 | Special | PDF ↗ |
| K252788 | Tornier Perform Reversed Monopost Glenoid (Perform Mono) | Tornier, Inc. | 2026-01-08 | Traditional | PDF ↗ |
| K250338 | MSS - Humeral reverse liners extension | Medacta International S.A. | 2025-10-31 | Traditional | PDF ↗ |
| K253345 | JARVIS Diaphyseal Stem Standard | FH Industrie | 2025-10-29 | Special | PDF ↗ |
| K252221 | Inset Reverse Total Shoulder System | Shoulder Innovations, Inc. | 2025-09-26 | Traditional | PDF ↗ |
| K252411 | JARVIS Glenoid Reverse Shoulder Prosthesis | FH Industrie | 2025-08-28 | Special | PDF ↗ |
| K252141 | AltiVate Reverse® Glenoid | Encore Medical L.P. | 2025-08-05 | Special | PDF ↗ |
| K243448 | Equinoxe® Shoulder System | Exactech, Inc. | 2025-08-01 | Traditional | PDF ↗ |
| K243826 | SMR Reverse HP Shoulder System | Lima Corporate S.P.A. | 2025-07-03 | Traditional | PDF ↗ |
| K243643 | restor3d Reverse Total Shoulder Arthroplasty System | Restor3D | 2025-05-19 | Traditional | PDF ↗ |
| K251184 | AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System | Encore Medical L.P. | 2025-05-16 | Special | PDF ↗ |
| K242253 | JARVIS Glenoid Reverse Shoulder Prosthesis | FH Industrie | 2024-11-25 | Traditional | PDF ↗ |
| K241491 | Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid | Stryker Corporation (Tornier, S.A.S.) | 2024-10-10 | Traditional | PDF ↗ |
| K233482 | Equinoxe® Central Screw Baseplate System | Exactech, Inc. | 2024-07-18 | Traditional | PDF ↗ |
| K233481 | AltiVate Reverse® Glenoid | Encore Medical L.P. | 2024-05-29 | Traditional | PDF ↗ |
| K241043 | Augment Off-Axis Instrument System | Fix Surgical | 2024-05-15 | Special | PDF ↗ |
| K240278 | Full Wedge Lateralized and Augmented Baseplates | Fx Shoulder USA, Inc. | 2024-05-15 | Traditional | PDF ↗ |
| K234105 | Catalyst F1x Shoulder System | Catalyst Orthoscience, Inc. | 2024-04-05 | Traditional | PDF ↗ |
| K233148 | Augment Off-Axis Instrument System | Fix Surgical | 2024-03-22 | Traditional | PDF ↗ |
| K232265 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2024-02-21 | Traditional | PDF ↗ |
| K231445 | LINK Embrace Shoulder System - Reverse Configuration | Waldemar Link GmbH & Co. KG | 2023-11-16 | Traditional | PDF ↗ |
| K231911 | Glenoid Reconstruction System Full Wedge Baseplate | Medacta International S.A. | 2023-11-09 | Traditional | PDF ↗ |
| K232583 | Catalyst R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2023-09-20 | Special | PDF ↗ |
| K223833 | Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays | Exactech, Inc. | 2023-09-14 | Traditional | PDF ↗ |
| K232226 | ARROW Off-Centred Humeral Insert | FH Industrie | 2023-08-29 | Special | PDF ↗ |
| K223801 | FX V135(TM) Shoulder Prosthesis | Fx Shoulder USA, Inc. | 2023-06-05 | Traditional | PDF ↗ |
| K223655 | Catalyst R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2023-05-09 | Traditional | PDF ↗ |
| K230366 | Arthrex Univers Revers Monoblock Stem Size 4/33 | Arthrex, Inc. | 2023-04-10 | Traditional | PDF ↗ |
| K214001 | Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System | Biomet Manufacturing Corp | 2023-03-15 | Traditional | PDF ↗ |
| K223211 | INHANCETM Shoulder System Humeral Stems and Stemless | Depuy Ireland UC | 2022-12-02 | Traditional | PDF ↗ |
| K213459 | Glenoid Reconstruction System | Medacta International S.A. | 2022-11-23 | Traditional | PDF ↗ |
| K222936 | Humeris® 135 Shoulder System | Fx Shoulder USA, Inc. | 2022-11-07 | Traditional | PDF ↗ |
| K220914 | Tornier Perform Humeral System Fracture | Tornier, Inc. | 2022-10-14 | Traditional | PDF ↗ |
| K221467 | INHANCETM Reverse Glenoid Peripheral Posts | Depuy Ireland UC | 2022-08-31 | Traditional | PDF ↗ |
| K213349 | Catalyst R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2022-06-23 | Traditional | PDF ↗ |
| K213117 | FX V135 Shoulder Prosthesis | Fx Shoulder USA, Inc. | 2022-06-07 | Traditional | PDF ↗ |
| K212737 | INHANCE Reverse Shoulder System | Depuy Ireland UC | 2022-04-21 | Traditional | PDF ↗ |
| K212800 | PRIMA Humeral System and SMR Glenosphere Ø42 | Lima Corporate S.P.A. | 2022-02-25 | Traditional | PDF ↗ |
| K202024 | ARROW Short Stem Humeral System | FH Industrie | 2021-11-30 | Traditional | PDF ↗ |
| K212992 | LINK® Embrace Shoulder System - Reverse Configuration | Waldemar Link GmbH & Co. KG | 2021-11-18 | Traditional | PDF ↗ |
| K212415 | Arthrex Modular Glenoid System-Titanium Glenosphere | Arthrex, Inc. | 2021-11-17 | Traditional | PDF ↗ |
| K211359 | Tornier Perform Patient-Matched Primary Reversed Glenoid and BLUEPRINT Patient Specific Instrumentation | Tornier, Inc. | 2021-11-12 | Traditional | PDF ↗ |
| K211729 | Comprehensive® Convertible Glenoid - Vivacit-E Liner | Biomet Manufacturing Corp | 2021-11-04 | Traditional | PDF ↗ |
| K213124 | Tomier Perform Reversed Glenoid Cannulated Glenospheres | Tornier, Inc. | 2021-10-26 | Special | PDF ↗ |
| K212710 | GLOBAL UNITE Platform Shoulder System | Depuy Ireland UC | 2021-09-15 | Special | PDF ↗ |
| K211074 | Univers Revers Modular Glenoid System, Standard Augment Baseplates | Arthrex, Inc. | 2021-09-02 | Traditional | PDF ↗ |
| K210790 | Lateralized and Augmented Baseplates | Fx Shoulder USA, Inc. | 2021-08-25 | Traditional | PDF ↗ |
| K210533 | Inset Reverse Total Shoulder System | Shoulder Innovations, Inc. | 2021-08-20 | Traditional | PDF ↗ |
| K211553 | Tecomet Global Unite Short Stem Instrumentation | Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc. | 2021-08-04 | Traditional | PDF ↗ |
| K211991 | Catalyst R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2021-07-28 | Special | PDF ↗ |
| K203694 | DELTA XTEND Reverse Shoulder System | Depuy Ireland UC | 2021-07-22 | Traditional | PDF ↗ |
| K210717 | Bone Screws dia. 5,0 mm | Lima Corporate S.P.A. | 2021-07-12 | Traditional | PDF ↗ |
| K203375 | OVOMotion Reverse Shoulder Arthroplasty System | Arthrosurface, Inc. | 2021-06-24 | Traditional | PDF ↗ |
| K210207 | Humeral Eccentric Reverse Metaphysis | Medacta International S.A. | 2021-03-26 | Traditional | PDF ↗ |
| K203755 | Shoulder System - TiNbN Coating | Medacta International S.A. | 2021-03-02 | Traditional | PDF ↗ |
| K210167 | DELTA XTEND Reverse Shoulder System | DePuy Orthopaedics, Inc. | 2021-02-19 | Special | PDF ↗ |
| K202232 | Comprehensive Vault Reconstruction System | Biomet Manufacturing Corp | 2021-02-19 | Traditional | PDF ↗ |
| K202611 | Catalyst OrthoScience R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2021-02-12 | Traditional | PDF ↗ |
| K200368 | LINK Embrace Shoulder System - Reverse Configuration | Waldemar Link GmbH & Co. KG | 2021-02-05 | Traditional | PDF ↗ |
| K202098 | GLOBAL UNITE Platform Shoulder System | Depuy Ireland UC | 2020-11-25 | Traditional | PDF ↗ |
| K200171 | SMR TT Augmented Glenoid System | Lima Corporate S.P.A. | 2020-11-19 | Traditional | PDF ↗ |
| K200895 | Univers Revers Modular Glenoid System, Half Augment Baseplate | Arthrex, Inc. | 2020-08-13 | Traditional | PDF ↗ |
| K193175 | Lateralized Glenosphere | Medacta Inernational SA | 2020-08-11 | Traditional | PDF ↗ |
| K191146 | Humelock TiN Coated Glenosphere | Fx Shoulder USA, Inc. | 2020-07-15 | Traditional | PDF ↗ |
| K193394 | Humeral Cup Stability & Humeral Cup 135/145o Stability | Fx Shoulder USA, Inc. | 2020-04-29 | Traditional | PDF ↗ |
| K193373 | Comprehensive® Reverse Shoulder | Biomet, Inc. | 2020-04-15 | Traditional | PDF ↗ |
| K192967 | Medacta Shoulder System | Medacta International S.A. | 2020-03-25 | Traditional | PDF ↗ |
| K192855 | DELTA XTEND(TM) Reverse Shoulder System | Depuy(Ireland) | 2020-02-24 | Traditional | PDF ↗ |
| K192799 | Glenoid Baseplate with Screw | Fx Shoulder USA, Inc. | 2020-02-21 | Traditional | PDF ↗ |
| K193098 | Exactech® Equinoxe® Reverse Shoulder Glenospheres | Exactech, Inc. | 2020-02-20 | Special | PDF ↗ |
| K193099 | Anatomical Shoulder System | Zimmer GmbH | 2020-01-29 | Traditional | PDF ↗ |
| K193372 | Univers Revers Modular Glenoid System (Augemented baseplates) | Arthrex, Inc. | 2020-01-10 | Special | PDF ↗ |
| K191960 | Arthrex Univers Revers Modular Glenoid System | Arthrex, Inc. | 2019-12-23 | Special | PDF ↗ |
| K190738 | MyShoulder Placement Guides | Medacta International S.A. | 2019-12-13 | Traditional | PDF ↗ |
| K190588 | Integra TITAN Reverse Shoulder System | Integra LifeSciences Corporation | 2019-12-02 | Traditional | PDF ↗ |
| K191746 | SMR TT Augmented Glenoid System | Lima Corporate S.P.A. | 2019-11-22 | Traditional | PDF ↗ |
| K192206 | 32mm Glenosphere and Humeral Cup | Fx Shoulder USA, Inc. | 2019-10-08 | Traditional | PDF ↗ |
| K192448 | Delta Xtend Revers Shoulder System | Depuy(Ireland) | 2019-10-04 | Special | PDF ↗ |
| K191561 | Exactech Equinoxe Humeral Augmented Trays | Exactech, Inc. | 2019-08-20 | Traditional | PDF ↗ |
| K183077 | Delta Xtend Reverse Shoulder System | Depuy(Ireland) | 2019-05-17 | Traditional | PDF ↗ |
| K183696 | Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid | Tornier, Inc. | 2019-01-30 | Special | PDF ↗ |
| K181826 | Glenoid Polyaxial Non-locking Screws | Medacta International S.A. | 2018-12-10 | Traditional | PDF ↗ |
| K182536 | Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap | Exactech, Inc. | 2018-10-12 | Special | PDF ↗ |
| K181999 | Integra TITAN Reverse Shoulder System | Integra LifeSciences Corporation | 2018-10-12 | Traditional | PDF ↗ |
| K182039 | Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay | Arthrex, Inc. | 2018-09-28 | Traditional | PDF ↗ |
Product code PHX · Class II · Orthopedic. Data: openFDA.