MSS - Monobloc stem
FDA 510(k) clearance K250644 · decided 2026-02-03
Clearance details
- K-number
- K250644
- Device name
- MSS - Monobloc stem
- Applicant
- Medacta International S.A.
- Decision
- Substantially Equivalent
- Date received
- 2025-03-04
- Decision date
- 2026-02-03
- Days to decision
- 336 days
- Clearance type
- Traditional
- Product code
- PHX
- Device class
- 2
- Regulation number
- 888.3660
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Castel San Pietro, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Short Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971, 9/04.01.10.0972, recall (Z-2618-2026) | Medacta Usa Inc | 2026-06-29 |