# K222564: Treace Medical Concepts (TMC) Hammertoe Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Treace Medical Concepts, Inc.
- Decided: Nov 15, 2022 after 83 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K911837 (1991). 104 ancestors in all.
No later device cites it as a predicate yet.
0 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132912: Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal Implant, In2bones Sas (2014) Summary page 4.
- K140148: Pro-Toe Hammertoe Fixation System, Wrightmedicaltechnologyinc (2014) Summary page 4.

## Indications for use
The TMC Hammertoe Fixation System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants in the TMC Hammertoe Fixation System can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint). The Implantable K-Wires are indicated for use in fixation of bone fractures, for bone reconstructions, and as guide pins for insertion of other implants. Additionally, Implantable K-Wires are indicated for the fixation of osteotomies and reconstruction of the lesser toe following correction procedures for hammertoe, claw toe, mallet toe, and metatarsophalangeal joint instability.

Source page: https://510kreport.com/device/K222564
Methodology: https://510kreport.com/methodology