RESTORIS POROUS PARTIAL KNEE SYSTEM
FDA 510(k) clearance K133811 · decided 2014-07-08
Clearance details
- K-number
- K133811
- Device name
- RESTORIS POROUS PARTIAL KNEE SYSTEM
- Applicant
- Mako Surgical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2013-12-16
- Decision date
- 2014-07-08
- Days to decision
- 204 days
- Clearance type
- Traditional
- Product code
- NJD
- Device class
- 2
- Regulation number
- 888.3535
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- New York, NY, 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 - Porous Coated CoCrMo Femoral Component (K251975) | Ignite Orthomotion | 2025-09-02 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.