# K113752: Metatarsal Decompression Implant Surgical Instrument Set

- Pathway: 510(k) (Traditional)
- Applicant: Solana Surgical, LLC
- Decided: Feb 6, 2012 after 47 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.
10 later devices descend from it; 1 cites it directly.
0 of 25 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.
- K023770: K2 Hemi Toe Implant System (Formerly Zobel Great Toe Implant System), Kinetikos Medical, Inc. (2002) Summary page 1.
- K073065: Osteomed Metatarsal Resurfacing Implant System, Osteomed LP (2008) Summary page 1.

## Cited in the summary but kept off the family tree
- K091027: Unnamed device. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- 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
- K222964: BioPoly Lesser Toe Hemiarthroplasty Implant (2022), 1 descendant 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 or press fit without bone cement.

Source page: https://510kreport.com/device/K113752
Methodology: https://510kreport.com/methodology