MSS - Humeral reverse liners extension
FDA 510(k) K261016 · Medacta International, SA
510(k) numberK261016
Submission
- Device name
- MSS - Humeral reverse liners extension
- Applicant
- Medacta International, SA
Castel San Pietro, CH - Received
- March 27, 2026
- Decision date
- June 10, 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 |
| 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 |
| K250644 | MSS - Monobloc stemPHX · Traditional | Medacta International S.A. | 02/03/2026SE |
More from Medacta International S.A.
| 510(k) | Device | Decision |
|---|---|---|
| K160605 | MectaLIF Anterior Stand-AloneOVD · Traditional | 07/21/2016SE |
| K160289 | MasterLoc StemLZO · Traditional | 05/20/2016SE |
| K153664 | M.U.S.T. Pedicle Screw SystemNKB · Special | 01/19/2016SE |
| K151531 | MasterLoc StemLZO · Traditional | 10/30/2015SE |
| K142744 | Mecta-C TiPEEKODP · Traditional | 05/07/2015SE |
| K143453 | Mpact Double Mobility SystemLPH · Traditional | 03/02/2015SE |
| K142069 | GMK ExtensionJWH · Traditional | 12/02/2014SE |
| K141988 | M.U.S.T Pedicle Screw SystemNKB · Special | 08/19/2014SE |
| K141044 | M.U.S.T. ExtensionNKB · Traditional | 08/18/2014SE |
| K140826 | GMK Sphere ExtensionJWH · Traditional | 07/15/2014SE |
Questions and answers
When was MSS - Humeral reverse liners extension cleared by the FDA?
MSS - Humeral reverse liners extension (K261016) received a 510(k) decision of Substantially Equivalent on June 10, 2026, 75 days after the submission was received.
What is the product code of K261016?
The FDA product code is PHX – Shoulder Prosthesis, Reverse Configuration, a Class II (moderate risk) device regulated under 21 CFR 888.3660.