# K971047: Futura Biomedical Metal Hemi Toe Implant

- Pathway: 510(k) (Traditional)
- Applicant: Nexa Orthopedics, Inc.
- Decided: Jun 20, 1997 after 91 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 K864492 (1987). 1 ancestor in all.
28 later devices descend from it; 6 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K864492: Swanson Titanium Great Toe Implant, Dow Corning Wright (1987) Summary page 1.

## Most influential descendants
- K031859: Cap Great Toe Resurfacing Hemi-Arthroplasty Implant (2004), 23 descendants of its own
- K070052: Met-Head Model# MHDD-XX:CC Diameter, CC Cannulation (2007), 18 descendants of its own
- K063370: Cap 7.0MM MTP Resurfacing Hemi-Arthroplasty (2007), 16 descendants of its own
- K060536: Osteomed 1ST MPJ Hemi Implant System (2006), 16 descendants of its own
- K073065: Osteomed Metatarsal Resurfacing Implant System (2008), 15 descendants of its own

## Indications for use
Hallux limitus or hallux rigidous. Painful hallux valgus. Revision of failed previous surgery. Painful arthritis.

Source page: https://510kreport.com/device/K971047
Methodology: https://510kreport.com/methodology