# K062908: Orthropro Hemi Toe

- Pathway: 510(k) (Traditional)
- Applicant: Orthopro, LLC
- Decided: Nov 13, 2006 after 47 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: 2 generations back to K864492 (1987). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971047: Futura Biomedical Metal Hemi Toe Implant, Nexa Orthopedics, Inc. (1997) Summary page 1.
- K023770: K2 Hemi Toe Implant System (Formerly Zobel Great Toe Implant System), Kinetikos Medical, Inc. (2002) Summary page 1.
- K911378: Townley Great Toe Joint, Biopro, Inc. (1991) Summary page 1.

## Most influential descendants
- K071243: Metal Hemi Implant (2007), 0 descendants of its own

## Indications for use
The Ortho/Pro Hemi Toe is designed to supplement first metatarsal phalangeal joint arthroplasty. Indications include hallux limitus or hallux rigidius, painful hallux valgus, revision of failed previous surgery and painful arthritis.

Source page: https://510kreport.com/device/K062908
Methodology: https://510kreport.com/methodology