# K090127: Metatarsal Decompression Implant, Model 100

- Pathway: 510(k) (Traditional)
- Applicant: Solana Surgical, LLC
- Decided: May 1, 2009 after 100 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). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070052: Met-Head Model# MHDD-XX:CC Diameter, CC Cannulation, Vilex, Inc. (2007) Summary page 1.
- K031859: Cap Great Toe Resurfacing Hemi-Arthroplasty Implant, Arthrosurface, Inc. (2004) Summary page 1.

## Most influential descendants
- K201393: restor3d MTP Implant (2022), 0 descendants of its own
- K161279: Life Spine Metatarsal Hemi Implant (2017), 0 descendants of its own

## Indications for use
The Solana Surgical LLC, Metatarsal Decompression Implant is intended for use as a hemi-arthroplasty implant for the first metatarsophalangeal joint, for the treatment of degenerative and post-traumatic arthritis, 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.

Source page: https://510kreport.com/device/K090127
Methodology: https://510kreport.com/methodology