FDA product code PHX: Shoulder Prosthesis, Reverse Configuration
PHX is the FDA product code for shoulder prosthesis, reverse configuration. It is a Class II device, regulated under 21 CFR 888.3660 and reviewed by the Orthopedic panel. FDA has cleared 201 510(k) submissions under PHX, 48 in the last five years, from 41 different applicants. The average 510(k) review took 143 days (median 125); 140 days on average over the last three years. FDA has posted 61 recalls for PHX devices, 41 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Shoulder Prosthesis, Reverse Configuration |
| Device class | Class II |
| Regulation | 21 CFR 888.3660 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for PHX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 11 | 177 |
| 2018 | 14 | 139 |
| 2019 | 9 | 134 |
| 2020 | 13 | 169 |
| 2021 | 21 | 146 |
| 2022 | 9 | 189 |
| 2023 | 9 | 163 |
| 2024 | 9 | 150 |
| 2025 | 9 | 122 |
| 2026 | 12 | 149 |
Top PHX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Exactech, Inc. | 21 | 2026-04-14 |
| Encore Medical L.P. | 16 | 2026-01-15 |
| Biomet Manufacturing Corp | 13 | 2023-03-15 |
| Medacta International S.A. | 12 | 2026-02-03 |
| Lima Corporate S.P.A. | 11 | 2026-01-22 |
36 more applicants have PHX clearances. See the full list in Caduvo.
Most recent PHX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253992 | Restor3D | Veritas Reverse Total Shoulder System | 2026-05-07 | 146 |
| K252404 | Biomet Orthopedics | Comprehensive Reverse Shoulder - HA Glenosphere Baseplates | 2026-04-15 | 258 |
| K260583 | Exactech, Inc. | Equinoxe® Shoulder System | 2026-04-14 | 53 |
| K254128 | Shoulder Innovations, Inc. | InSet Reverse Total Shoulder System | 2026-04-13 | 112 |
| K253674 | Stryker Corporation (Tornier, S.A.S.) | Blueprint Patient-Specific Instrumentation | 2026-04-03 | 133 |
Recalls for PHX devices
61 product recalls in 33 recall events; 41 initiated in the last five years and 33 still open. Most recent: 2026-01-15.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2019 | 3 |
| 2020 | 11 |
| 2021 | 10 |
| 2023 | 8 |
| 2024 | 12 |
| 2025 | 12 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code PHX?
PHX is the FDA product code for shoulder prosthesis, reverse configuration. It is a Class II device, regulated under 21 CFR 888.3660 and reviewed by the Orthopedic panel.
What device class is PHX?
Class II, regulation 21 CFR 888.3660. Typical premarket route: 510(k).
How long does a 510(k) take for product code PHX?
Across 201 cleared submissions the average was 143 days from receipt to decision (median 125).
Which companies have the most PHX clearances?
Exactech, Inc. (21); Encore Medical L.P. (16); Biomet Manufacturing Corp (13); Medacta International S.A. (12); Lima Corporate S.P.A. (11).
Have PHX devices been recalled?
Yes: 61 product recalls across 33 recall events; the most recent began 2026-01-15.
Next steps
- Run an FDA pathway report with predicate devices for product code PHX
- Run a recall and safety report across every PHX manufacturer
- Watch product code PHX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.