# K161279: Life Spine Metatarsal Hemi Implant

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Feb 1, 2017 after 271 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: 6 generations back to K864492 (1987). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090127: Metatarsal Decompression Implant, Model 100, Solana Surgical, LLC (2009) Summary page 4.
- K081876: Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite Coating, Osteomed LP (2008) Summary page 4.

## Indications for use
The Life Spine Metatarsal Hemi 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 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/K161279
Methodology: https://510kreport.com/methodology