# K014164: Great Toe Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Harmos Orthopaedics, Inc.
- Decided: Mar 12, 2002 after 83 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
No predicates in its family tree.
30 later devices descend from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Swanson Titanium Great Toe Implant System (Dow Corning Wright): named in the summary without a submission number
- (no number) Metallic Hemiarthroplasty Resurfacing Prosthesis (BioPro): named in the summary without a submission number
- (no number) Futura Biomedical Metal Hemi Toe Implant System (Futura Biomedical): named in the summary without a submission number

## Most influential descendants
- K023770: K2 Hemi Toe Implant System (Formerly Zobel Great Toe Implant System) (2002), 29 descendants of its own
- K031859: Cap Great Toe Resurfacing Hemi-Arthroplasty Implant (2004), 23 descendants of its own
- K070052: Met-Head Model# MHDD-XX:CC Diameter, CC Cannulation (2007), 18 descendants of its own
- K063370: Cap 7.0MM MTP Resurfacing Hemi-Arthroplasty (2007), 16 descendants of its own
- K060536: Osteomed 1ST MPJ Hemi Implant System (2006), 16 descendants of its own

## Indications for use
The Great Toe Implant System is indicated for use in the treatment of patients with inflammatory arthritis in the first metatarsal joint in the presence of good bone stock and integrity of the first metatarsal head, along with the following clinical conditions: hallux valgus, hallux rigidus and an unstable or painful MTP joint.

Source page: https://510kreport.com/device/K014164
Methodology: https://510kreport.com/methodology