# K000666: TC-Plus Solution Knee

- Pathway: 510(k) (Traditional)
- Applicant: Plus Orthopedics
- Decided: Oct 13, 2000 after 228 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: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K923277 (1993). 1 ancestor in all.
115 later devices descend from it; 5 cite it directly.
0 of 117 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.

## Most influential descendants
- K022204: VKS Knee System (2002), 70 descendants of its own
- K011258: TC-Plus Porous Femoral Components (2001), 54 descendants of its own
- K072858: TC-Plus Primary Knee System (2007), 53 descendants of its own
- K090988: GMK Total Knee System (2009), 52 descendants of its own
- K090705: Balanced Knee System Ultracongruent Tibial Insert (2009), 42 descendants of its own

## Recalls of this device
- Aug 3, 2005 · Not classified · Z-0013-06: Did not meet specifications.
- Aug 3, 2005 · Not classified · Z-0015-06: Did not meet specifications.
- Aug 3, 2005 · Not classified · Z-0016-06: Did not meet specifications.
- Aug 3, 2005 · Not classified · Z-0017-06: Did not meet specifications.
- Aug 3, 2005 · Not classified · Z-0014-06: Did not meet specifications.
- Aug 3, 2005 · Not classified · Z-0018-06: Did not meet specifications.
- Aug 3, 2005 · Not classified · Z-0019-06: Did not meet specifications.
- Feb 22, 2005 · Not classified · Z-0126-06: Labeling discrepancy.
- Apr 17, 2003 · Not classified · Z-0017-04: Labeling/packaging mix-up.

## Indications for use
The TC-PLUS" Solution Knee is intended as a cemented surface replacement in treating patients who are candidates for primary total knee arthroplasty or revision knee arthroplasty. It is indicated for degenerative, post-traumatic or rheumatoid arthritis, avascular necrosis of-the --femoral condyle, post-traumatic loss of joint configuration, in particular in the event of patello-femoral erosion, functional disability or an earlier patOlectomy; moderate varus, vaigus or flexure deformity and to correct earlier unsuccessful attempts at surgery.

Source page: https://510kreport.com/device/K000666
Methodology: https://510kreport.com/methodology