# K213036: Treace Medical Concepts (TMC) Screw Fixation System

- Pathway: 510(k) (Special)
- Applicant: Treace Medical Concepts, Inc.
- Decided: Oct 21, 2021 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: 12 generations back to K962616 (1996). 178 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 186 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172617: Treace Medical Concepts (TMC) Compression Screw System, Treace Medical Concepts, Inc. (2017) Summary page 4.

## Most influential descendants
- K240173: Treace Medical Systems (TMC) Plating System (2024), 4 descendants of its own
- 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
- K242671: Treace Medical Concepts (TMC) Screw Fixation System (2024), 1 descendant of its own

## Indications for use
The Treace Medical Concepts (TMC) Screw Fixation System is intended for use for adult and pediatric patients aged >12 years, and indicated for small or long bones requiring fixation of fractures, fracture repair, revision procedures, joint fusions (arthrodesis), bone reconstructions, osteotomy, ligament fixation, and pseudoarthrosis (non-unions) of bones, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, phalanges, patella, ulnar styloid, capitellum, radial head and radial styloid. In the foot, the following specific examples are indicated with screws appropriate for the size of the device: • mono or bicortical osteotomies • distal or proximal metatarsal osteotomies • weil osteotomy • fusion of the metatarsalphalangeal joint • fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.) • Akin type osteotomy • talonavicular fusions • cuboid fusions Not for spinal use.

Source page: https://510kreport.com/device/K213036
Methodology: https://510kreport.com/methodology