# K173723: EMPOWR Universal Tibial Baseplate

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Mar 5, 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: 9 generations back to K810258 (1981). 42 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 45 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.
- K932425: Foundation Modular Tibial Baseplate, Encore Orthopedics, Inc. (1994) Summary page 4.
- K100900: Motivation Knee System, Encore Medical L.P. (2010) Summary page 4.

## Most influential descendants
- K213793: EMPOWR Revision Knee (2022), 1 descendant of its own
- K230441: EMPOWR Stem Extender, 50mm (2023), 0 descendants of its own

## Recalls of this device
- Aug 4, 2023 · Class II · Z-2603-2023: Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, 

## 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.

Source page: https://510kreport.com/device/K173723
Methodology: https://510kreport.com/methodology