# K031859: Cap Great Toe Resurfacing Hemi-Arthroplasty Implant

- Pathway: 510(k) (Traditional)
- Applicant: Arthrosurface, Inc.
- Decided: Feb 18, 2004 after 247 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). 6 ancestors in all.
23 later devices descend from it; 9 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)
- K781870: Implant, H.P. Condylar, Dow Corning Corp. Healthcare Industries Materials (1979) Summary page 2.
- K864492: Swanson Titanium Great Toe Implant, Dow Corning Wright (1987) Summary page 2.
- K023770: K2 Hemi Toe Implant System (Formerly Zobel Great Toe Implant System), Kinetikos Medical, Inc. (2002) Summary page 2.
- K971047: Futura Biomedical Metal Hemi Toe Implant, Nexa Orthopedics, Inc. (1997) Summary page 2.
- K911378: Townley Great Toe Joint, Biopro, Inc. (1991) Summary page 2.

## Most influential descendants
- 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
- K073065: Osteomed Metatarsal Resurfacing Implant System (2008), 15 descendants of its own
- K081876: Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite Coating (2008), 13 descendants of its own
- K102401: Hemi Implant; Mini Hemi Implant (2011), 11 descendants of its own

## Indications for use
Hemi-arthroplasty implant for first metatarsophalangeal joint for use in the treatment of patients with degenerative and post-traumatic arthritis in the first metatarsal joint in the presence of good bone stock along with the following clinical conditions; hallux valgus or hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement.

Source page: https://510kreport.com/device/K031859
Methodology: https://510kreport.com/methodology