# K120029: Hemi Phalangeal Implant Surgical Instrument Set

- Pathway: 510(k) (Traditional)
- Applicant: Solana Surgical, LLC
- Decided: Feb 6, 2012 after 33 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 K014164 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023684: Cannulated Metallic Hemi Toe Implant, Models MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365, Vilex, Inc. (2004) Summary page 1.
- K023770: K2 Hemi Toe Implant System (Formerly Zobel Great Toe Implant System), Kinetikos Medical, Inc. (2002) Summary page 1.

## Indications for use
The Solana Surgical LLC, Hemi Phalangeal 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 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/K120029
Methodology: https://510kreport.com/methodology