Equinoxe® Shoulder System
FDA 510(k) K260583 · Exactech, Inc.
510(k) numberK260583
Submission
- Device name
- Equinoxe® Shoulder System
- Applicant
- Exactech, Inc.
Gainesville, FL, US - Received
- February 20, 2026
- Decision date
- April 14, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PHX – Shoulder Prosthesis, Reverse Configuration
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3660
- Specialty
- Orthopedic
- Implant
- Yes
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.
Other 510(k)s with product code PHX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260556 | Veritas Shoulder SystemPHX · Traditional | Restor3D | 07/01/2026SE |
| K261683 | Augment Off-Axis Instrument SystemPHX · Special | Zimmer, Inc. | 06/16/2026SE |
| K260102 | Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder…PHX · Traditional | Stryker Corporation (Tornier, Inc.) | 06/12/2026SE |
| K261016 | MSS - Humeral reverse liners extensionPHX · Traditional | Medacta International, SA | 06/10/2026SE |
| K253992 | Veritas Reverse Total Shoulder SystemPHX · Traditional | Restor3D | 05/07/2026SE |
| K252404 | Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesPHX · Traditional | Biomet Orthopedics | 04/15/2026SE |
| K254128 | InSet Reverse Total Shoulder SystemPHX · Traditional | Shoulder Innovations, Inc. | 04/13/2026SE |
| K253674 | Blueprint Patient-Specific InstrumentationPHX · Traditional | Stryker Corporation (Tornier, S.A.S.) | 04/03/2026SE |
| K253624 | INHANCE Reverse Shoulder SystemPHX · Traditional | Depuy Ireland UC | 03/11/2026SE |
| K250644 | MSS - Monobloc stemPHX · Traditional | Medacta International S.A. | 02/03/2026SE |
More from Medacta International S.A.
| 510(k) | Device | Decision |
|---|---|---|
| K250713 | Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsKWT · Traditional | 12/01/2025SE |
| K243448 | Equinoxe® Shoulder SystemPHX · Traditional | 08/01/2025SE |
| K243275 | Equinoxe® Scapula Fracture SystemHRS · Traditional | 06/26/2025SE |
| K243839 | Alteon® HA Femoral StemsMEH · Traditional | 03/10/2025SE |
| K240393 | Exactech® TRULIANT® Knee SystemMBH · Traditional | 10/03/2024SE |
| K233482 | Equinoxe® Central Screw Baseplate SystemPHX · Traditional | 07/18/2024SE |
| K230717 | Exactech® Vantage® Total Ankle SystemHSN · Traditional | 10/12/2023SE |
| K223933 | Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsHRS · Traditional | 09/25/2023SE |
| K223833 | Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysPHX · Traditional | 09/14/2023SE |
| K232002 | Vantage® Total Ankle SystemHSN · Traditional | 09/11/2023SE |
Questions and answers
When was Equinoxe® Shoulder System cleared by the FDA?
Equinoxe® Shoulder System (K260583) received a 510(k) decision of Substantially Equivalent on April 14, 2026, 53 days after the submission was received.
What is the product code of K260583?
The FDA product code is PHX – Shoulder Prosthesis, Reverse Configuration, a Class II (moderate risk) device regulated under 21 CFR 888.3660.