# K171991: EMPOWR Porous Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Oct 4, 2017 after 93 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- Recalls of this device: 3 (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). 43 ancestors in all.
1 later device descends 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.
- K032905: 3DKNEE Porous Coated Femoral Component, Encore Orthopedics, Inc. (2004) Summary page 5.

## Most influential descendants
- K210308: EMPOWR Porous Femur with HAnano SurfaceTM (2021), 0 descendants of its own

## Recalls of this device
- Nov 10, 2023 · Class II · Z-0508-2024: Due to incorrect product/device within packaging.
- Sep 29, 2023 · Class II · Z-0258-2024: Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lead to a disruption in surgery.
- Aug 3, 2020 · Class II · Z-0060-2021: There is a potential for the retaining pin of the tibial punch handle to become loose and fall out while impacting. If undetected, there is a potential of leaving debris in the joint space.

## 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, 3DKNEE™ Porous Coated Tibia, and EMPOWR 3DKNEE™ Porous Tibia which are intended for cementless applications.

Source page: https://510kreport.com/device/K171991
Methodology: https://510kreport.com/methodology