# K260361: Treace Medical Concepts (TMC) Screw Fixation System

- Pathway: 510(k) (Special)
- Applicant: Treace Medical Concepts, Inc.
- Decided: Mar 6, 2026 after 30 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: 14 generations back to K962616 (1996). 242 ancestors in all.
No later device cites it as a predicate yet.
0 of 243 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242671: Treace Medical Concepts (TMC) Screw Fixation System, Treace Medical Concepts, Inc. (2024) Summary page 5.
- K201132: Arthrex Compression Screws, Arthrex, Inc. (2020) Summary page 5.
- K143624: Headless Compression Screw System, Skeletal Dynamics, LLC (2015) Summary page 5.

## Indications for use
The TMC Screw Fixation System is intended for primary and revision fracture fixation and repair, joint fusions (arthrodesis), bone reconstructions, osteotomies, pseudoarthroses (non-unions), and ligament fixation. The System is indicated for use in adult and pediatric patients > 12 years of age at the following anatomical sites: * Upper extremity: glenoid, humerus, ulna, radius, and hand * Lower extremity: tibia, fibula, patella, ankle, and foot. Indicated procedures include: o Fusions (e.g., talocalcaneal, talonavicular, naviculocuneiform, calcanealcuboid, tarsometatarsal, metatarsophalangeal, and interphalangeal) o Mono or bi-cortical osteotomies of the tarsals, metatarsals, and phalanges (e.g., Scarf, Chevron, Akin, Weil, and Transverse osteotomies for hallux valgus, tailor's bunion, metatarsus adductus, flatfoot, and hammertoe deformities).

Source page: https://510kreport.com/device/K260361
Methodology: https://510kreport.com/methodology