# K243658: TMC Compression Implant System

- Pathway: 510(k) (Special)
- Applicant: Treace Medical Concepts
- Decided: Dec 26, 2024 after 29 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: 18 generations back to K954385 (1996). 263 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 266 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242415: TMC Compression Implant System, Treace Medical Concepts (2024) Summary page 5.
- K122113: Memory Metal Staples, Easyclip, Stryker Corp. (2013) Summary page 5.

## Most influential descendants
- 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/K243658
Methodology: https://510kreport.com/methodology