# K161945: EXPRT Revision Knee Femoral Augment (5mm), EXPRT Revision Knee Stem Extension (40mm)

- Pathway: 510(k) (Special)
- Applicant: Encore Medical L.P.
- Decided: Sep 23, 2016 after 70 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: 9 generations back to K810258 (1981). 49 ancestors in all.
No later device cites it as a predicate yet.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941306: Foundation Knee Augmentation Blocks, Encore Orthopedics, Inc. (1995) Summary page 4.
- K140830: Exprt Revision Knee, Encore Medical L.P. (2014) Summary page 4.

## 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. This system is to be used for cemented applications. Exprt Revision Knee Femoral Augments are also to be attached to the femoral component with bone cement.

Source page: https://510kreport.com/device/K161945
Methodology: https://510kreport.com/methodology