# K081876: Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite Coating

- Pathway: 510(k) (Special)
- Applicant: Osteomed LP
- Decided: Aug 1, 2008 after 30 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: 5 generations back to K864492 (1987). 14 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073065: Osteomed Metatarsal Resurfacing Implant System, Osteomed LP (2008) Summary page 1.

## Most influential descendants
- K102401: Hemi Implant; Mini Hemi Implant (2011), 11 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
- K190543: Cannulated Hemi Implant (2019), 5 descendants of its own
- K203634: BioPoly Great Toe Hemiarthroplasty Implant (2021), 2 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/K081876
Methodology: https://510kreport.com/methodology