Mpact Constrained Liner
FDA 510(k) clearance K241461 · decided 2025-07-31
Clearance details
- K-number
- K241461
- Device name
- Mpact Constrained Liner
- Applicant
- Medacta International S.A.
- Decision
- Substantially Equivalent
- Date received
- 2024-05-23
- Decision date
- 2025-07-31
- Days to decision
- 434 days
- Clearance type
- Traditional
- Product code
- KWZ
- Device class
- 2
- Regulation number
- 888.3310
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Castel San Pietro, CH
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medacta International S.A.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.