Product code PHX
- Device name
- Shoulder Prosthesis, Reverse Configuration
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3660
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253992 | Veritas Reverse Total Shoulder System | Restor3D | 2026-05-07 |
| K252404 | Comprehensive Reverse Shoulder - HA Glenosphere Baseplates | Biomet Orthopedics | 2026-04-15 |
| K260583 | Equinoxe® Shoulder System | Exactech, Inc. | 2026-04-14 |
| K254128 | InSet Reverse Total Shoulder System | Shoulder Innovations, Inc. | 2026-04-13 |
| K253674 | Blueprint Patient-Specific Instrumentation | Stryker Corporation (Tornier, S.A.S.) | 2026-04-03 |
| K253624 | INHANCE™ Reverse Shoulder System | Depuy Ireland UC | 2026-03-11 |
| K250644 | MSS - Monobloc stem | Medacta International S.A. | 2026-02-03 |
| K252352 | SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System | Lima Corporate S.P.A. | 2026-01-22 |
| K252567 | AltiVate Reverse® ADLC Glenosphere | Encore Medical L.P. | 2026-01-15 |
| K252516 | N22 EZ Glenosphere | Shoulder Innovations, Inc. | 2026-01-15 |
| K254003 | JARVIS Metaphyseal Stem | FH Industrie | 2026-01-09 |
| K252788 | Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) | Tornier, Inc. | 2026-01-08 |
| K250338 | MSS - Humeral reverse liners extension | Medacta International S.A. | 2025-10-31 |
| K253345 | JARVIS Diaphyseal Stem Standard | FH Industrie | 2025-10-29 |
| K252221 | Inset Reverse Total Shoulder System | Shoulder Innovations, Inc. | 2025-09-26 |
| K252411 | JARVIS Glenoid Reverse Shoulder Prosthesis | FH Industrie | 2025-08-28 |
| K252141 | AltiVate Reverse® Glenoid | Encore Medical L.P. | 2025-08-05 |
| K243448 | Equinoxe® Shoulder System | Exactech, Inc. | 2025-08-01 |
| K243826 | SMR Reverse HP Shoulder System | Lima Corporate S.P.A. | 2025-07-03 |
| K243643 | restor3d Reverse Total Shoulder Arthroplasty System | Restor3D | 2025-05-19 |
| K251184 | AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System | Encore Medical L.P. | 2025-05-16 |
| K242253 | JARVIS Glenoid Reverse Shoulder Prosthesis | FH Industrie | 2024-11-25 |
| K241491 | Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid | Stryker Corporation (Tornier, S.A.S.) | 2024-10-10 |
| K233482 | Equinoxe® Central Screw Baseplate System | Exactech, Inc. | 2024-07-18 |
| K233481 | AltiVate Reverse® Glenoid | Encore Medical L.P. | 2024-05-29 |
| K240278 | Full Wedge Lateralized and Augmented Baseplates | Fx Shoulder USA, Inc. | 2024-05-15 |
| K241043 | Augment Off-Axis Instrument System | Fix Surgical | 2024-05-15 |
| K234105 | Catalyst F1x Shoulder System | Catalyst Orthoscience, Inc. | 2024-04-05 |
| K233148 | Augment Off-Axis Instrument System | Fix Surgical | 2024-03-22 |
| K232265 | BLUEPRINT™ Patient Specific Instrumentation | Tornier S.A.S. | 2024-02-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840097535715 | Veritas rTSA | Restor3d, Inc. | 2026-06-03 |
| 00840097535692 | Veritas rTSA | Restor3d, Inc. | 2026-06-03 |
| 00840097535678 | Veritas rTSA | Restor3d, Inc. | 2026-06-03 |
| 00888867061170 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867061408 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867061378 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867061330 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867061323 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867061316 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867061293 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867061279 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867061255 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867061248 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867061217 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867061187 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867061422 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867061149 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867061132 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867061026 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867057944 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867057937 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867057753 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867057739 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867057722 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867057357 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867057340 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867062320 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867062313 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867061446 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867061439 | Arthrex® | ARTHREX, INC. | 2017-02-15 |