PHX — Shoulder Prosthesis, Reverse Configuration Class II
FDA product code PHX covers "Shoulder Prosthesis, Reverse Configuration", a Class II medical device regulated under 21 CFR 888.3660. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PHX
- Device Class
- Class II
- Regulation Number
- 888.3660
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260556 | restor3d | Veritas Shoulder System | July 1, 2026 |
| K261683 | zimmer | Augment Off-Axis Instrument System | June 16, 2026 |
| K260102 | stryker corporation (tornier, inc.) | Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid | June 12, 2026 |
| K261016 | medacta international | MSS - Humeral reverse liners extension | June 10, 2026 |
| K253992 | restor3d | Veritas Reverse Total Shoulder System | May 7, 2026 |
| K252404 | biomet orthopedics | Comprehensive Reverse Shoulder - HA Glenosphere Baseplates | April 15, 2026 |
| K260583 | exactech | Equinoxe® Shoulder System | April 14, 2026 |
| K254128 | shoulder innovations | InSet Reverse Total Shoulder System | April 13, 2026 |
| K253674 | stryker corporation (tornier, s.a.s.) | Blueprint Patient-Specific Instrumentation | April 3, 2026 |
| K253624 | depuy ireland uc | INHANCE Reverse Shoulder System | March 11, 2026 |
| K250644 | medacta international | MSS - Monobloc stem | February 3, 2026 |
| K252352 | lima corporate | SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System | January 22, 2026 |
| K252567 | encore medical l.p | AltiVate Reverse® ADLC Glenosphere | January 15, 2026 |
| K252516 | shoulder innovations | N22 EZ Glenosphere | January 15, 2026 |
| K254003 | fh industrie | JARVIS Metaphyseal Stem | January 9, 2026 |
| K252788 | tornier | Tornier Perform Reversed Monopost Glenoid (Perform Mono) | January 8, 2026 |
| K250338 | medacta international | MSS - Humeral reverse liners extension | October 31, 2025 |
| K253345 | fh industrie | JARVIS Diaphyseal Stem Standard | October 29, 2025 |
| K252221 | shoulder innovations | Inset Reverse Total Shoulder System | September 26, 2025 |
| K252411 | fh industrie | JARVIS Glenoid Reverse Shoulder Prosthesis | August 28, 2025 |