JARVIS Diaphyseal Stem Standard
FDA 510(k) K253345 · FH Industrie
510(k) numberK253345
Submission
- Device name
- JARVIS Diaphyseal Stem Standard
- Applicant
- FH Industrie
Quimper Finistere, FR - Received
- September 30, 2025
- Decision date
- October 29, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K254003 | JARVIS Metaphyseal StemPHX · Special | 01/09/2026SE |
| K252411 | JARVIS Glenoid Reverse Shoulder ProsthesisPHX · Special | 08/28/2025SE |
| K242253 | JARVIS Glenoid Reverse Shoulder ProsthesisPHX · Traditional | 11/25/2024SE |
| K232226 | ARROW Off-Centred Humeral InsertPHX · Special | 08/29/2023SE |
| K220758 | e-Ortho Shoulder Software v1.1LLZ · Traditional | 09/30/2022SE |
| K202024 | ARROW Short Stem Humeral SystemPHX · Traditional | 11/30/2021SE |
| K200127 | TELEGRAPH® EVOLUTION Humeral Nailing SystemHSB · Traditional | 10/01/2020SE |
| K201928 | e-Ortho Shoulder SoftwareLLZ · Traditional | 09/30/2020SE |
Questions and answers
When was JARVIS Diaphyseal Stem Standard cleared by the FDA?
JARVIS Diaphyseal Stem Standard (K253345) received a 510(k) decision of Substantially Equivalent on October 29, 2025, 29 days after the submission was received.
What is the product code of K253345?
The FDA product code is PHX – Shoulder Prosthesis, Reverse Configuration, a Class II (moderate risk) device regulated under 21 CFR 888.3660.