Restoris Multi-Compartmental Knee System
FDA 510(k) clearance K220930 · decided 2022-06-02
Clearance details
- K-number
- K220930
- Device name
- Restoris Multi-Compartmental Knee System
- Applicant
- Mako Surgical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2022-03-31
- Decision date
- 2022-06-02
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- HSX
- Device class
- 2
- Regulation number
- 888.3520
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Weston, FL, 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 |
|---|---|---|
| Tahoe Unicondylar Knee System with TiNbN Overcoat (K260796) | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | 2026-04-02 |
| Cambridge Partial Knee (K251771) | Signature Orthopaedics Pty, Ltd. | 2025-12-16 |
| Persona Partial Knee (K251834) | Zimmer Biomet | 2025-08-15 |
| MOTO Partial Knee System Extension (K251618) | Medacta International S.A. | 2025-07-24 |
| Arthrex iBalance Partial Knee System (K251453) | Arthrex, Inc. | 2025-07-01 |
| ACTIFY™ Unicondylar Knee System (K241260) | Globus Medical, Inc. | 2024-12-06 |
| JOURNEY II Unicompartmental Knee System (JOURNEY II UK) (K242711) | Smith & Nephew, Inc. | 2024-10-30 |
| OvertureTi Knee Resurfacing SystemTM (K242746) | Overture Orthopaedics | 2024-10-07 |
| TRIBRID® Unicompartmental Knee System (K232114) | Kyocera Medical Technologies, Inc. | 2024-04-04 |
| Uni Knee Resurfacing System (K221292) | Overture Resurfacing, Inc. | 2023-03-10 |
| TLC Unicompartmental Knee System (K212870) | Signature Orthopaedics Pty, Ltd. | 2022-06-16 |
| Balanced Knee System Uni (K211471) | Ortho Development Corporation | 2021-12-16 |
Recalls involving this device
No recalls on record reference this clearance.