# K121973: Biopro Hemi-Edge Toe System

- Pathway: 510(k) (Traditional)
- Applicant: Biopro, Inc.
- Decided: Oct 30, 2012 after 117 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 K911378 (1991). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041595: Toe MP Joint, Models 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870, Biopro, Inc. (2004) Summary page 1.
- K911378: Townley Great Toe Joint, Biopro, Inc. (1991) Summary page 1.

## Most influential descendants
- K200951: Accu-Joint Hemi Implant (2020), 1 descendant of its own
- K240268: Accu-Joint Hemi Implant (2024), 0 descendants of its own

## Indications for use
A press fit implant for arthritic degradation of the metatarso-phalangeal joint that has 'resulted in disabling pain, limited motion and loss of the normal ambulatory function of the forefoot. Degenerative arthritis Rheumetoid arthritis Bunion deformity associated with arthritis of the metatarsal-phalangeal joint A titanium version is available for use only in patients susceptible to nickel chromium allergies. The BioPro Hemi-Edge Toe System is not intended for spinal use.

Source page: https://510kreport.com/device/K121973
Methodology: https://510kreport.com/methodology