# K100370: Symmetric Total Knee Aguments

- Pathway: 510(k) (Traditional)
- Applicant: Signal Medical Corp.
- Decided: Mar 7, 2011 after 388 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: 5 generations back to K982302 (1998). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043440: Smith & Nephew, Inc. Revision Knee System, Smith & Nephew, Inc. (2005) Summary page 1.
- K053505: Regenerex Ultra Porous Construct-Femoral and Tibial Knee Augments, Biomet Manufacturing, Inc. (2006) Summary page 1.
- K072336: Regenerex Porous Titanium Sleeve Augments, Biomet Manufacturing Corp (2007) Summary page 1.
- K053340: Trabecular Metal Tibial and Femoral Cone Augments, Zimmer Trabecular (2006) Summary page 1.
- K953274: Genesis Porous Tibial Trays & Revision Knee System, Smith & Nephew Richards, Inc. (1996) Summary page 1.

## Cited in the summary but kept off the family tree
- K080199: Symmetric Total Knee System, Signal Medical Corporation (2008). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Symmetric™ Total Knee Augments consist of single use components intended for attachment to the Symmetric Total Knee implants during total knee arthroplasty with the following indications. 1. Osteoarthritis 2. Rheumatoid Arthritis 3. Traumatic Arthritis or correction of posttraumatic joint deformity 4. Where the use of a more conservative procedure has failed or is unacceptable. All components are for cemented use. Additional indications for use: * Whenever a cone is used, a revision stem is to be used as well.

Source page: https://510kreport.com/device/K100370
Methodology: https://510kreport.com/methodology