MSS - Humeral reverse liners extension— 510(k) K261016
Substantially EquivalentMedacta International, SA
FDA 510(k) clearance K261016 for MSS - Humeral reverse liners extension, Substantially Equivalent on 2026-06-10. Applicant: Medacta International, SA. Device class: 2.
Summary
Medacta International's device is named "MSS - Humeral reverse liners extension," filed under PHX, reverse-configuration shoulder prostheses. The record doesn't expand "MSS" or describe the liners beyond the name.
Class II, 21 CFR 888.3660. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Medacta filed from Castel San Pietro, Switzerland. The decision came 75 calendar days after FDA received it (March 27 to June 10, 2026).
Clearance details
- Applicant
- Medacta International, SA
- Product code
- Product code PHX
- Device class
- Class 2
- Regulation
- 21 CFR 888.3660
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Castel San Pietro, CH
Recent devices under product code PHX
view allMore clearances from Medacta International, SA
view allAdverse events under product code PHX
product code PHX- Death
- 10
- Injury
- 9,705
- Malfunction
- 1,252
- Total
- 10,967
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.