# K262963: TMC Implant Fixation System

- Pathway: 510(k) (Special)
- Applicant: Treace Medical Concepts, Inc.
- Decided: Sep 15, 2026 after 21 days
- Product code: HRS (Plate, 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: 20 generations back to K954385 (1996). 268 ancestors in all.
No later device cites it as a predicate yet.
0 of 269 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251135: Treace Medical Concepts (TMC) Implant Fixation System, Treace Medical Concepts (2025) Summary page 5.
- K190970: PROSTEP™ TBI™ (Tailors Bunion Implant) System, Wrightmedicaltechnologyinc (2019) Summary page 5.

## Indications for use
The TMC Implant Fixation System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of the feet. The system can be used in pediatric (aged >12 years-21) and adult (aged 22 and over) patients. In the foot, the system can be used for the following specific examples: •Osteotomy of the 1st and/or 5th Metatarsals for the treatment of deformity (e.g., hallux valgus,hallux rigidus, hallux limitus, tailor's bunion) such as: - Opening base wedge osteotomy - Closing base wedge osteotomy - Crescentic osteotomy - Proximal Chevron osteotomy - Distal Chevron osteotomy (Austin) - Transverse osteotomy •Arthrodesis of the tarsometatarsal (TMT) joints or the 1st metatarsophalangeal (MTP) joint for the treatment of deformity (e.g., hallux valgus, hallux rigidus, metatarsus adductus) and/or arthritis •First metatarsal fracture fixation •Flatfoot Osteotomies - Lateral Column Lengthening (Evans Osteotomy) - Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy) •Mid / Flatfoot Fusions - LisFranc Arthrodesis and/or Stabilization - lntercuneiform Fusions - Navicular-Cuneiform (NC) Fusion - Talo-Navicular (TN) Fusion - Calcaneo-Cuboid (CC) Fusion - Medial Column Fusion

Source page: https://510kreport.com/device/K262963
Methodology: https://510kreport.com/methodology