EMPOWR Porous Knee System
FDA 510(k) clearance K171991 · decided 2017-10-04
Clearance details
- K-number
- K171991
- Device name
- EMPOWR Porous Knee System
- Applicant
- Encore Medical L.P.
- Decision
- Substantially Equivalent
- Date received
- 2017-07-03
- Decision date
- 2017-10-04
- Days to decision
- 93 days
- Clearance type
- Traditional
- Product code
- MBH
- Device class
- 2
- Regulation number
- 888.3565
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX recall (Z-0508-2024) | Encore Medical, LP | 2023-12-07 |
| DJO EMPOWR Knee Punch Handle, REF: 801-05-040 recall (Z-0258-2024) | Encore Medical, LP | 2023-11-07 |
| DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instru recall (Z-0060-2021) | Encore Medical, LP | 2020-10-07 |