# K160342: EMPOWR PS Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: May 19, 2016 after 101 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: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K810258 (1981). 42 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143242: Rebel 3DKNEE System, Encore Medical L.P. (2015) Summary page 4.
- K933539: Foundation Posterior Stabilized Knee, Encore Orthopedics, Inc. (1994) Summary page 4.
- K100900: Motivation Knee System, Encore Medical L.P. (2010) Summary page 4.
- K121727: Movation Knee System, Encore Medical L.P. (2012) Summary page 4.

## Most influential descendants
- K180930: Empowr VVC Tibial Insert (2018), 3 descendants of its own
- K230169: EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert (2023), 2 descendants of its own
- K213793: EMPOWR Revision Knee (2022), 1 descendant 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
- Sep 15, 2017 · Class II · Z-0041-2018: It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.
- Sep 15, 2017 · Class II · Z-0042-2018: It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.
- Jan 10, 2017 · Class II · Z-1139-2017: The Empowr PS Insert was reported as missing the impaction slot feature.
- Sep 19, 2016 · Class II · Z-0325-2017: It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery. The current design of the captured box 
- Sep 19, 2016 · Class II · Z-0766-2017: It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery.

## 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 3SDKNEE™ Porous Coated Femur which is 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/K160342
Methodology: https://510kreport.com/methodology