# K072858: TC-Plus Primary Knee System

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Nov 20, 2007 after 46 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: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K923277 (1993). 4 ancestors in all.
53 later devices descend from it; 1 cites it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000666: TC-Plus Solution Knee, Plus Orthopedics (2000) Summary page 1.
- K011258: TC-Plus Porous Femoral Components, Plus Orthopedics (2001) Summary page 1.
- K022204: VKS Knee System, Plus Orthopedics (2002) Summary page 1.

## Most influential descendants
- K090988: GMK Total Knee System (2009), 52 descendants of its own
- K102437: GMK Revision Knee System (2010), 34 descendants of its own
- K103170: GMK Revision Knee SC Liners (2011), 28 descendants of its own
- K113571: GMK Resufacing Patella Size 4 (2012), 23 descendants of its own
- K121416: GMK Sphere (2012), 20 descendants of its own

## Recalls of this device
- Mar 11, 2016 · Class II · Z-1544-2016: The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during sur
- Mar 11, 2016 · Class II · Z-1539-2016: The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during sur
- Mar 11, 2016 · Class II · Z-1538-2016: The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during sur
- Mar 11, 2016 · Class II · Z-1547-2016: The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during sur
- Mar 11, 2016 · Class II · Z-1551-2016: The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during sur
- Mar 11, 2016 · Class II · Z-1546-2016: The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during sur
- Mar 11, 2016 · Class II · Z-1537-2016: The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during s
- Mar 11, 2016 · Class II · Z-1540-2016: The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during sur
- Mar 11, 2016 · Class II · Z-1545-2016: The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during sur
- Mar 11, 2016 · Class II · Z-1542-2016: The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during sur
- Mar 11, 2016 · Class II · Z-1549-2016: The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during sur
- Mar 11, 2016 · Class II · Z-1550-2016: The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during sur
- Mar 11, 2016 · Class II · Z-1543-2016: The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during sur
- Mar 11, 2016 · Class II · Z-1548-2016: The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during sur
- Mar 11, 2016 · Class II · Z-1541-2016: The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during sur

## Indications for use
The TC-PLUS Primary Knee is intended as a cemented surface replacement in treating patients who are candidates for primary total knee adhroplasty or revision knee arthroplasy. 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 patel[ectomy; moderate varus, va[gus or flexure deformity and to correct earlier unsuccessful attempts at surgery.

Source page: https://510kreport.com/device/K072858
Methodology: https://510kreport.com/methodology