Humeris® 135 Shoulder System
FDA 510(k) K222936 · Fx Shoulder USA, Inc.
510(k) numberK222936
Submission
- Device name
- Humeris® 135 Shoulder System
- Applicant
- Fx Shoulder USA, Inc.
Dallas, TX, US - Received
- September 26, 2022
- Decision date
- November 7, 2022
- 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 |
|---|---|---|
| K240278 | Full Wedge Lateralized and Augmented BaseplatesPHX · Traditional | 05/15/2024SE |
| K223801 | FX V135(TM) Shoulder ProsthesisPHX · Traditional | 06/05/2023SE |
| K213117 | FX V135 Shoulder ProsthesisPHX · Traditional | 06/07/2022SE |
| K210790 | Lateralized and Augmented BaseplatesPHX · Traditional | 08/25/2021SE |
| K201391 | Easytech® Anatomical Shoulder SystemPKC · Traditional | 02/16/2021SE |
| K191698 | TiN Coated Humeral HeadKWT · Traditional | 07/16/2020SE |
| K191146 | Humelock TiN Coated GlenospherePHX · Traditional | 07/15/2020SE |
| K193394 | Humeral Cup Stability & Humeral Cup 135/145o StabilityPHX · Traditional | 04/29/2020SE |
| K192799 | Glenoid Baseplate with ScrewPHX · Traditional | 02/21/2020SE |
| K192206 | 32mm Glenosphere and Humeral CupPHX · Traditional | 10/08/2019SE |
Questions and answers
When was Humeris® 135 Shoulder System cleared by the FDA?
Humeris® 135 Shoulder System (K222936) received a 510(k) decision of Substantially Equivalent on November 7, 2022, 42 days after the submission was received.
What is the product code of K222936?
The FDA product code is PHX – Shoulder Prosthesis, Reverse Configuration, a Class II (moderate risk) device regulated under 21 CFR 888.3660.