# K122239: Foundation Knee System with Tinbn Coating Foundation PS Knee System with Tinbn Coating 3DKNEE System with Tinbn Coating

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Apr 11, 2013 after 258 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: 4 generations back to K936079 (1994). 19 ancestors in all.
20 later devices descend from it; 6 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923277: Foundation Knee System, Encore Orthopedics, Inc. (1993) Summary page 1.
- K933539: Foundation Posterior Stabilized Knee, Encore Orthopedics, Inc. (1994) Summary page 1.
- K020114: 3D KNEE, Encore Orthopedics, Inc. (2002) Summary page 1.
- K100900: Motivation Knee System, Encore Medical L.P. (2010) Summary page 1.
- K964008: Foundation Knee System, Encore Orthopedics, Inc. (1996) Summary page 1.

## Most influential descendants
- K152431: LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating (2016), 9 descendants of its own
- K182872: LINK GEMINI SL Total Knee System (2019), 8 descendants of its own
- K202684: GMK Total Knee System - TiNbN Coating (2020), 3 descendants of its own
- K202924: LinkSymphoKnee System (2021), 2 descendants of its own
- K200912: Freedom (R) - TiNbN Coated Knee (2020), 2 descendants of its own

## 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. The device is intended for cemented applications.

Source page: https://510kreport.com/device/K122239
Methodology: https://510kreport.com/methodology