# K232387: Treace Medical Concepts (TMC) Compression Implant System

- Pathway: 510(k) (Special)
- Applicant: Treace Medical Concepts
- Decided: Aug 28, 2023 after 19 days
- Product code: JDR (Staple, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K902307 (1990). 19 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222645: Treace Medical Concepts (TMC) Implant Fixation System, Treace Medical Concepts (2022) Summary page 4.
- K121277: Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-Staple, Z-Medical GmbH & Co. KG (2012) Summary page 4.

## Most influential descendants
- K242415: TMC Compression Implant System (2024), 3 descendants of its own
- K243658: TMC Compression Implant System (2024), 2 descendants of its own
- K251135: Treace Medical Concepts (TMC) Implant Fixation System (2025), 1 descendant of its own
- K262963: TMC Implant Fixation System (2026), 0 descendants of its own

## Indications for use
The system is intended to be used for fracture fixation, osteotomy fixation, and joint arthrodesis of the foot and ankle.

Source page: https://510kreport.com/device/K232387
Methodology: https://510kreport.com/methodology