Humelock Reversed Shoulder
FDA 510(k) K162455 · Fx Solutions
510(k) numberK162455
Submission
- Device name
- Humelock Reversed Shoulder
- Applicant
- Fx Solutions
Viriat, FR - Received
- September 2, 2016
- Decision date
- January 17, 2017
- 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 |
|---|---|---|
| K163669 | Humeris ShoulderPHX · Traditional | 05/17/2017SE |
| K150488 | Humelock II Reversible Shoulder SystemPHX · Traditional | 11/13/2015SE |
| K143721 | PRCT2HRS · Traditional | 08/27/2015SE |
| K140071 | Humelock II Cemented Shoulder SystemKWT · Traditional | 07/28/2014SE |
| K130759 | Humelock II Cementless Shoulder SystemHSD · Traditional | 11/09/2013SE |
| K123814 | Humelock II Cemented Shoulder SystemKWT · Traditional | 08/13/2013SE |
| K111097 | Humelock Cemented Shoulder ProsthesisHSD · Traditional | 11/09/2011SE |
Questions and answers
When was Humelock Reversed Shoulder cleared by the FDA?
Humelock Reversed Shoulder (K162455) received a 510(k) decision of Substantially Equivalent on January 17, 2017, 137 days after the submission was received.
What is the product code of K162455?
The FDA product code is PHX – Shoulder Prosthesis, Reverse Configuration, a Class II (moderate risk) device regulated under 21 CFR 888.3660.