Engage™ Partial Knee System
FDA 510(k) clearance K190439 · decided 2019-11-21
Clearance details
- K-number
- K190439
- Device name
- Engage™ Partial Knee System
- Applicant
- Engage Uni, LLC
- Decision
- Substantially Equivalent
- Date received
- 2019-02-25
- Decision date
- 2019-11-21
- Days to decision
- 269 days
- Clearance type
- Traditional
- Product code
- NJD
- Device class
- 2
- Regulation number
- 888.3535
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Winter Park, 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 |
|---|---|---|
| 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 |
| RESTORIS POROUS PARTIAL KNEE SYSTEM (K133811) | Mako Surgical Corp. | 2014-07-08 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Number recall (Z-1670-2023) | Smith & Nephew, Inc. | 2023-05-31 |
| Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) R recall (Z-1671-2023) | Smith & Nephew, Inc. | 2023-05-31 |
| Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a) R recall (Z-1672-2023) | Smith & Nephew, Inc. | 2023-05-31 |
| Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers: a) recall (Z-1673-2023) | Smith & Nephew, Inc. | 2023-05-31 |