# K063370: Cap 7.0MM MTP Resurfacing Hemi-Arthroplasty

- Pathway: 510(k) (Traditional)
- Applicant: Arthrosurface, Inc.
- Decided: Jan 12, 2007 after 65 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: 3 generations back to K864492 (1987). 7 ancestors in all.
16 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031859: Cap Great Toe Resurfacing Hemi-Arthroplasty Implant, Arthrosurface, Inc. (2004) Summary page 2.

## Most influential descendants
- 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
- K113752: Metatarsal Decompression Implant Surgical Instrument Set (2012), 10 descendants of its own
- K131377: Hemicap MTP Resurfacing Hemi-Arthroplasty Implant (2013), 9 descendants of its own

## Indications for use
Hemi-arthroplasty implant for the metatarsophalangeal joint for use in the treatment of patients with degenerative and post-traumatic arthritis in the metatarsal joint in the presence of good bone, stock along with the following clinical conditions: hallux valgus or hallux lirritus, 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/K063370
Methodology: https://510kreport.com/methodology