# K073065: Osteomed Metatarsal Resurfacing Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed LP
- Decided: Feb 21, 2008 after 114 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: 4 generations back to K864492 (1987). 13 ancestors in all.
15 later devices descend from it; 3 cite it directly.
0 of 29 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 1.
- K063370: Cap 7.0MM MTP Resurfacing Hemi-Arthroplasty, Arthrosurface, Inc. (2007) Summary page 1.
- K070052: Met-Head Model# MHDD-XX:CC Diameter, CC Cannulation, Vilex, Inc. (2007) Summary page 1.
- K060536: Osteomed 1ST MPJ Hemi Implant System, Osteomed LP (2006) Summary page 1.
- K922211: Osteomed Great Toe System, Osteomed Corp. (1993) Summary page 1.
- K041595: Toe MP Joint, Models 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870, Biopro, Inc. (2004) Summary page 1.

## Most influential descendants
- 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
- K152454: HemiCAP MTP Resurfacing Hemi-Arthroplasty System (2016), 6 descendants of its own

## Indications for use
The OsteoMed Metatarsal Resurfacing Implant, a hemi-arthroplasty implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions; hallux limitus, hallux valgus, hallux rigidus, and an unstable or painful MTP joint. The OsteoMed Metatarsal Resurfacing Implant is intended to be used with bone cement or press fit without bone cement. The OsteoMed Metatarsal Resurfacing Implant is intended for single use only.

Source page: https://510kreport.com/device/K073065
Methodology: https://510kreport.com/methodology