# K060536: Osteomed 1ST MPJ Hemi Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed LP
- Decided: Jun 2, 2006 after 94 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). 5 ancestors in all.
16 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041595: Toe MP Joint, Models 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870, Biopro, Inc. (2004) Summary page 1.
- K023770: K2 Hemi Toe Implant System (Formerly Zobel Great Toe Implant System), Kinetikos Medical, Inc. (2002) Summary page 1.
- K971047: Futura Biomedical Metal Hemi Toe Implant, Nexa Orthopedics, Inc. (1997) Summary page 1.

## 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
Indicated for use in the treatment of patients with inflammatory arthritis in the first metatarsal joint in the presence of good bone stock and integrity of the first metatarsal head, along with the following clinical conditions: hallux valgus, hallux rigidus and an unstable or painful metatarsophalangeal joint. OsteoMed 1st MPJ Hemi Implants are intended for single use only.

Source page: https://510kreport.com/device/K060536
Methodology: https://510kreport.com/methodology