PHX
- 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.
510(k) clearances, last 3 years (38)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260556 | 2026-07-01 | Restor3D | Veritas Shoulder System | |
| K261683 | 2026-06-16 | Zimmer, Inc. | Augment Off-Axis Instrument System | |
| K260102 | 2026-06-12 | Stryker Corporation (Tornier, Inc.) | Tornier Perform Reversed Glenoid and Tornier Perform… | FDA |
| K261016 | 2026-06-10 | Medacta International, SA | MSS - Humeral reverse liners extension | |
| K253992 | 2026-05-07 | Restor3D | Veritas Reverse Total Shoulder System | |
| K252404 | 2026-04-15 | Biomet Orthopedics | Comprehensive Reverse Shoulder - HA Glenosphere Base… | |
| K260583 | 2026-04-14 | Exactech, Inc. | Equinoxe® Shoulder System | |
| K254128 | 2026-04-13 | Shoulder Innovations, Inc. | InSet Reverse Total Shoulder System | |
| K253674 | 2026-04-03 | Stryker Corporation (Tornier, S.A.S.) | Blueprint Patient-Specific Instrumentation | |
| K253624 | 2026-03-11 | Depuy Ireland UC | INHANCE Reverse Shoulder System | |
| K250644 | 2026-02-03 | Medacta International S.A. | MSS - Monobloc stem | |
| K252352 | 2026-01-22 | Lima Corporate S.P.A. | SMR Shoulder System; PRIMA Glenoid System; PRIMA Hum… | |
| K252567 | 2026-01-15 | Encore Medical L.P. | AltiVate Reverse® ADLC Glenosphere | |
| K252516 | 2026-01-15 | Shoulder Innovations, Inc. | N22 EZ Glenosphere | |
| K254003 | 2026-01-09 | FH Industrie | JARVIS Metaphyseal Stem | |
| K252788 | 2026-01-08 | Tornier, Inc. | Tornier Perform Reversed Monopost Glenoid (Perform … | FDA |
| K250338 | 2025-10-31 | Medacta International S.A. | MSS - Humeral reverse liners extension | |
| K253345 | 2025-10-29 | FH Industrie | JARVIS Diaphyseal Stem Standard | FDA |
| K252221 | 2025-09-26 | Shoulder Innovations, Inc. | Inset Reverse Total Shoulder System | |
| K252411 | 2025-08-28 | FH Industrie | JARVIS Glenoid Reverse Shoulder Prosthesis | |
| K252141 | 2025-08-05 | Encore Medical L.P. | AltiVate Reverse® Glenoid | |
| K243448 | 2025-08-01 | Exactech, Inc. | Equinoxe® Shoulder System | |
| K243826 | 2025-07-03 | Lima Corporate S.P.A. | SMR Reverse HP Shoulder System | |
| K243643 | 2025-05-19 | Restor3D | restor3d Reverse Total Shoulder Arthroplasty System | |
| K251184 | 2025-05-16 | Encore Medical L.P. | AltiVate Reverse Shoulder System; RSP Shoulder Syste… | FDA |
| K242253 | 2024-11-25 | FH Industrie | JARVIS Glenoid Reverse Shoulder Prosthesis | |
| K241491 | 2024-10-10 | Stryker Corporation (Tornier, S.A.S.) | Blueprint Patient-Specific Instrumentation; Shoulder… | |
| K233482 | 2024-07-18 | Exactech, Inc. | Equinoxe® Central Screw Baseplate System | |
| K233481 | 2024-05-29 | Encore Medical L.P. | AltiVate Reverse® Glenoid | |
| K240278 | 2024-05-15 | Fx Shoulder USA, Inc. | Full Wedge Lateralized and Augmented Baseplates | |
| K241043 | 2024-05-15 | Fix Surgical | Augment Off-Axis Instrument System | |
| K234105 | 2024-04-05 | Catalyst Orthoscience, Inc. | Catalyst F1x Shoulder System | |
| K233148 | 2024-03-22 | Fix Surgical | Augment Off-Axis Instrument System | FDA |
| K232265 | 2024-02-21 | Tornier S.A.S. | BLUEPRINT Patient Specific Instrumentation | |
| K231445 | 2023-11-16 | Waldemar Link GmbH & Co. KG | LINK Embrace Shoulder System - Reverse Configuration | |
| K231911 | 2023-11-09 | Medacta International S.A. | Glenoid Reconstruction System Full Wedge Baseplate | |
| K232583 | 2023-09-20 | Catalyst Orthoscience, Inc. | Catalyst R1 Reverse Shoulder System | |
| K223833 | 2023-09-14 | Exactech, Inc. | Exactech® Equinoxe® Reverse Humeral Liners and Humer… |
Official FDA classification page: PHX
Classification and pathway per current FDA publications. Data from openFDA (CC0).