# K021063: Great Toe Implant

- Pathway: 510(k) (Traditional)
- Applicant: Signal Medical Corp.
- Decided: Jul 1, 2002 after 90 days
- Product code: KWD (Prosthesis, Toe, Hemi-, Phalangeal)
- Device class: 2
- Regulation: 21 CFR 888.3730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K823405 (1983). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911378: Townley Great Toe Joint, Biopro, Inc. (1991) Summary page 1.
- K823405: Zimmer Great Toe, Zimmer, Inc. (1983) Summary page 1.

## Indications for use
Osteoarthritis Where the use of a more conservative procedure has failed or is unacceptable, The device is intended for non-cemented use.

Source page: https://510kreport.com/device/K021063
Methodology: https://510kreport.com/methodology