# K183363: Treace Medical Concepts (TMC) Snap-Off Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Treace Medical Concepts, Inc.
- Decided: Jun 13, 2019 after 191 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). 179 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 181 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991477: Spin Snap-Off Screw, New Deal, S.A. (1999) Summary page 6.
- K172617: Treace Medical Concepts (TMC) Compression Screw System, Treace Medical Concepts, Inc. (2017) Summary page 6.

## Most influential descendants
- K230946: Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L (2023), 0 descendants of its own

## Indications for use
The Treace Medical Concepts, Inc (TMC) Snap-Off Screw System is intended for use for adult and pediatric patients, as 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, 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 • fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.) • Akin type osteotomy Not for spinal use.

Source page: https://510kreport.com/device/K183363
Methodology: https://510kreport.com/methodology