Inset Reverse Total Shoulder System
FDA 510(k) K252221 · Shoulder Innovations, Inc.
510(k) numberK252221
Submission
- Device name
- Inset Reverse Total Shoulder System
- Applicant
- Shoulder Innovations, Inc.
Grand Rapids, MI, US - Received
- July 16, 2025
- Decision date
- September 26, 2025
- 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 |
| K260583 | Equinoxe® Shoulder SystemPHX · Traditional | Exactech, Inc. | 04/14/2026SE |
| 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 |
More from Depuy Ireland UC
| 510(k) | Device | Decision |
|---|---|---|
| K262173 | N22 Offset Humeral HeadKWT · Traditional | 09/08/2026SE |
| K254128 | InSet Reverse Total Shoulder SystemPHX · Traditional | 04/13/2026SE |
| K252516 | N22 EZ GlenospherePHX · Traditional | 01/15/2026SE |
| K241817 | InSet Total Shoulder SystemKWT · Traditional | 02/11/2025SE |
| K213615 | Shoulder Innovations Total Shoulder SystemPKC · Traditional | 03/11/2022SE |
| K210533 | Inset Reverse Total Shoulder SystemPHX · Traditional | 08/20/2021SE |
| K192365 | Shoulder Innovations Total Shoulder SystemKWT · Special | 11/29/2019SE |
| K173824 | Humeral Short Stem SystemMBF · Traditional | 10/23/2018SE |
| K111596 | Total Shoulder SystemKWS · Special | 07/05/2011SE |
| K110905 | Total Shoulder SystemKWS · Special | 05/24/2011SE |
Questions and answers
When was Inset Reverse Total Shoulder System cleared by the FDA?
Inset Reverse Total Shoulder System (K252221) received a 510(k) decision of Substantially Equivalent on September 26, 2025, 72 days after the submission was received.
What is the product code of K252221?
The FDA product code is PHX – Shoulder Prosthesis, Reverse Configuration, a Class II (moderate risk) device regulated under 21 CFR 888.3660.