# K023086: Classic Great Toe Implant

- Pathway: 510(k) (Special)
- Applicant: Nexa Orthopedics, Inc.
- Decided: Oct 4, 2002 after 17 days
- Product code: KWH (Prosthesis, Toe, Constrained, Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K780132 (1978). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981194: Futura Biomedical Flexible Great Toe Implant, Nexa Orthopedics, Inc. (1998) Summary page 1.

## Most influential descendants
- K023562: Modification to Classic Great Toe Implant (2002), 0 descendants of its own

## Indications for use
Futura Biomedical Classic Great Toe Implant is indicated for: Hallux l'mitus or hallux rigidus Painful rheumatoid arthritis Hallux abduct0 valgus associated with arthritis Unstable or painfid joint from previous surgery

Source page: https://510kreport.com/device/K023086
Methodology: https://510kreport.com/methodology