# K023770: K2 Hemi Toe Implant System (Formerly Zobel Great Toe Implant System)

- Pathway: 510(k) (Special)
- Applicant: Kinetikos Medical, Inc.
- Decided: Dec 12, 2002 after 30 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: 1 generation back to K014164 (2002). 1 ancestor in all.
29 later devices descend from it; 7 cite 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)
- K014164: Great Toe Implant System, Harmos Orthopaedics, Inc. (2002)

## Most influential descendants
- 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
- K073065: Osteomed Metatarsal Resurfacing Implant System (2008), 15 descendants of its own

## Indications for use
The K2 Hemi 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/K023770
Methodology: https://510kreport.com/methodology