MOVATION KNEE SYSTEM
FDA 510(k) clearance K121727 · decided 2012-08-15
Clearance details
- K-number
- K121727
- Device name
- MOVATION KNEE SYSTEM
- Applicant
- Encore Medical L.P.
- Decision
- Substantially Equivalent
- Date received
- 2012-06-12
- Decision date
- 2012-08-15
- Days to decision
- 64 days
- Clearance type
- Special
- Product code
- OIY
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DePuy ATTUNE™ Knee System (K252887) | DePuy Orthopaedics, Inc. | 2026-05-22 |
| DePuy ATTUNE™ Total Knee System (K242665) | Depuy Orthopedics, Inc. | 2024-11-01 |
| DePuy ATTUNE™ Total Knee System (K201347) | DePuy Orthopaedics, Inc. | 2020-06-18 |
| A200 KNEE SYSTEM (K120038) | Renovis Surgical Technologies, LLC | 2013-02-14 |
| HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PA (K113756) | Encore Medical L.P. | 2012-03-14 |
| DEPUY STTUNE (TM) PS KNEE SYSTEM (K111433) | DePuy Orthopaedics, Inc. | 2011-08-30 |
| DEPUY ATTUNE TOTAL KNEE SYSTEM (K103756) | DePuy Orthopaedics, Inc. | 2011-03-15 |
| HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS (K103223) | Encore Medical L.P. | 2010-12-21 |
| DEPUY ATTUNE KNEE SYSTEM (K101433) | DePuy Orthopaedics, Inc. | 2010-12-10 |
| HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712 (K091956) | Encore Medical L.P. | 2010-09-28 |
| E1 ANTIOXIDANT INFUSED TECHNOLOGY (K100048) | Biomet Manufacturing Corp | 2010-03-09 |
Recalls involving this device
No recalls on record reference this clearance.