# K140830: Exprt Revision Knee

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Jul 11, 2014 after 100 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: 8 generations back to K810258 (1981). 47 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933539: Foundation Posterior Stabilized Knee, Encore Orthopedics, Inc. (1994) Summary page 1.
- K100900: Motivation Knee System, Encore Medical L.P. (2010) Summary page 1.
- K121727: Movation Knee System, Encore Medical L.P. (2012) Summary page 1.
- K130365: X-Alt Highly Cross Linked VE Acetabular Liner, Encore Medical L.P. (2013)

## 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 16, 2015 · Class II · Z-0165-2016: The labeling is missing the size/diameter information.

## 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 patellofemaral erosion, dysfunction or prior patellectomy, *moderate valgus, vanas or flexion deformities; *treatment of fractures that are unmanageable using other techniques. The patient's joint must be anatomically and structurally suited to receive the selected implant(s). This device may also be indicated in the salvage of previously failed surgical attempts. This system is to be used for cemented applications

Source page: https://510kreport.com/device/K140830
Methodology: https://510kreport.com/methodology