EMPOWR Revision Knee (EMPOWR Revision VVC+, e+ Tibial Insert)
FDA 510(k) K251776 · Encore Medical L.P.
510(k) numberK251776
Submission
- Device name
- EMPOWR Revision Knee (EMPOWR Revision VVC+, e+ Tibial Insert)
- Applicant
- Encore Medical L.P.
Austin, TX, US - Received
- June 10, 2025
- Decision date
- July 8, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3560
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JWH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260063 | GSPE SpacerJWH · Traditional | The General Hospital Corporation, d/b/a… | 09/11/2026SE |
| K262293 | EVOLUTION MPX Total Knee SystemJWH · Traditional | Suzhou Microport Orthorecon Co., Ltd. | 09/10/2026SE |
| K262341 | b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and…JWH · Traditional | B-One Ortho, Corp. | 09/08/2026SE |
| K262130 | ATTUNE Revision Knee SystemJWH · Traditional | Depuy Orthopaedics, Inc. | 09/04/2026SE |
| K253961 | SK Knee SystemJWH · Traditional | Just Medical Devices (Tianjin) Co., Ltd. | 09/01/2026SE |
| K261563 | Freedom Total Knee System (E-Poly Tibial Liners)JWH · Traditional | Maxx Orthopedics, Inc. | 08/07/2026SE |
| K262251 | ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)JWH · Special | Globus Medical, Inc. | 07/31/2026SE |
| K261734 | Klassic Infection Spacer SystemJWH · Traditional | Total Joint Orthopedics, Inc. | 07/23/2026SE |
| K261458 | ATTUNE Total Knee System; ATTUNE Cementless Knee SystemJWH · Traditional | DePuy Ireland UC | 06/25/2026SE |
| K261032 | NovoKnee (SteriKnee)JWH · Special | NovoSource | 04/27/2026SE |
More from NovoSource
| 510(k) | Device | Decision |
|---|---|---|
| K252567 | AltiVate Reverse® ADLC GlenospherePHX · Traditional | 01/15/2026SE |
| K252974 | EMPOWR KneeJWH · Traditional | 12/19/2025SE |
| K251833 | EMPOWR Acetabular® Liner ExtensionLPH · Traditional | 11/12/2025SE |
| K252141 | AltiVate Reverse® GlenoidPHX · Special | 08/05/2025SE |
| K251241 | EMPOWR Revision Knee (EMPOWR Revision Knee Symmetric TT Cones)JWH · Traditional | 07/02/2025SE |
| K251184 | AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…PHX · Special | 05/16/2025SE |
| K241483 | ceramys femoral head systemLZO · Traditional | 02/07/2025SE |
| K233481 | AltiVate Reverse® GlenoidPHX · Traditional | 05/29/2024SE |
| K222592 | AltiVate® Anatomic Shoulder AG e+ with MarkersKWS · Abbreviated | 06/23/2023SE |
| K213387 | AltiVate® Anatomic Shoulder AG e+ with MarkersKWS · Traditional | 07/07/2022SE |
Questions and answers
When was EMPOWR Revision Knee (EMPOWR Revision VVC+, e+ Tibial Insert) cleared by the FDA?
EMPOWR Revision Knee (EMPOWR Revision VVC+, e+ Tibial Insert) (K251776) received a 510(k) decision of Substantially Equivalent on July 8, 2025, 28 days after the submission was received.
What is the product code of K251776?
The FDA product code is JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3560.