# K180930: Empowr VVC Tibial Insert

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Jul 9, 2018 after 90 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K810258 (1981). 50 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K160342: EMPOWR PS Knee System, Encore Medical L.P. (2016) Summary page 5.
- K140830: Exprt Revision Knee, Encore Medical L.P. (2014) Summary page 5.
- K933539: Foundation Posterior Stabilized Knee, Encore Orthopedics, Inc. (1994) Summary page 5.

## Most influential descendants
- K230169: EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert (2023), 2 descendants of its own
- 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

## Recalls of this device
- Dec 22, 2022 · Class II · Z-1187-2023: Tibial insert implant large boxes were labeled small and the small boxes were labeled large. If the incorrect labeling is identified this could lead to surgical delay and if the surgeon does not recog

## 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 Porous™ Knee Femur and EMPOWR Porous™ Knee 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.

Source page: https://510kreport.com/device/K180930
Methodology: https://510kreport.com/methodology