# K230169: EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical, L.P Dba Enovis
- Decided: Apr 6, 2023 after 76 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K810258 (1981). 51 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180930: Empowr VVC Tibial Insert, Encore Medical L.P. (2018) Summary page 4.

## Most influential descendants
- K251776: EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) (2025), 0 descendants of its own
- K251241: EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) (2025), 0 descendants of its own

## Indications for use
Joint replacement is indicated for patients suffering from disability due to: • degenerative, post-traumatic or rheumatoid arthritis; • avascular necrosis of the femoral condyle; • post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; • moderate valgus, varus or flexion deformities; • treatment of fractures that are unmanageable using other techniques. This device may also be indicated in the salvage of previously failed surgical attempts. All devices are intended for cemented applications except for the 3DKNEE™ Porous Coated Femur, EMPOWR 3DKNEE™ POROUS Femur, and EMPOWR POROUS Tibia which are intended for cementless applications. While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. The EMPOWR Revision VVC+, e+ Tibial Insert should be considered for use in total knee arthroplasty for patients under the following indications: • absence or loss of both cruciate ligaments • moderate varus-valgus or flexion instability that requires a bearing surface with increased constraint in the clinical judgement of the surgeon • bone loss that requires supplemental fixation in the clinical judgement of the surgeon

Source page: https://510kreport.com/device/K230169
Methodology: https://510kreport.com/methodology