Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component
FDA 510(k) clearance K251975 · decided 2025-09-02
Clearance details
- K-number
- K251975
- Device name
- Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component
- Applicant
- Ignite Orthomotion
- Decision
- Substantially Equivalent
- Date received
- 2025-06-26
- Decision date
- 2025-09-02
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- NJD
- Device class
- 2
- Regulation number
- 888.3535
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Winona Lake, IN, 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 |
|---|---|---|
| ACHIEVE Partial Knee System (K242307) | Ignite Orthomotion | 2024-12-16 |
| JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System (K222653) | Smith+Nephew, Inc. | 2022-10-28 |
| Engage™ Partial Knee System (K190439) | Engage Uni, LLC | 2019-11-21 |
| RESTORIS POROUS PARTIAL KNEE SYSTEM (K133811) | Mako Surgical Corp. | 2014-07-08 |
Recalls involving this device
No recalls on record reference this clearance.