# K131187: Lesser Metatarsal Head Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Solana Surgical, LLC
- Decided: Oct 22, 2013 after 179 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: 7 generations back to K864492 (1987). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 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.
- K102401: Hemi Implant; Mini Hemi Implant, Vilex, Inc. (2011) Summary page 1.

## Indications for use
The Solana Surgical LLC, Lesser Metatarsal Head Implant System is intended for use as a hemi- arthroplasty implant for the metatarsophalangeal joint, for the treatment of degenerative and post-traumatic arthritis, hallux limitus, hallux valgus, hallux rigidus, and an unstable or painful metatarsophalangeal (MTP) joint. The device is intended for single use to be used with bone cement or press fit without bone cement.

Source page: https://510kreport.com/device/K131187
Methodology: https://510kreport.com/methodology