PHX — Shoulder Prosthesis, Reverse Configuration Class II
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 |
|---|---|---|---|
| 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 |
| K252141 | encore medical l.p | AltiVate Reverse® Glenoid | August 5, 2025 |
| K243448 | exactech | Equinoxe® Shoulder System | August 1, 2025 |
| K243826 | lima corporate | SMR Reverse HP Shoulder System | July 3, 2025 |
| K243643 | restor3d | restor3d Reverse Total Shoulder Arthroplasty System | May 19, 2025 |
| K251184 | encore medical l.p | AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIM | May 16, 2025 |