# K153531: Treace Medical Concepts (TMC) Plating System

- Pathway: 510(k) (Special)
- Applicant: Treace Medical Concepts, Inc.
- Decided: Jan 7, 2016 after 29 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: 11 generations back to K954385 (1996). 54 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143717: Treace Medical Concepts (TMC) Plating System, Treace Medical Concepts, Inc. (2015) Summary page 6.

## Most influential descendants
- K192504: Treace Medical Concepts (TMC) Plating System (2019), 10 descendants of its own
- K200961: Treace Medical Concepts (TMC) Plating System (2020), 9 descendants of its own
- K220136: Treace Medical Concepts (TMC) Plating System (2022), 8 descendants of its own
- K221181: Treace Medical Concepts (TMC) Plating System (2023), 7 descendants of its own
- K240173: Treace Medical Systems (TMC) Plating System (2024), 4 descendants of its own

## Indications for use
The TMC Plating System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet. In the foot, the system can be used for the following specific examples: -- First metatarsal osteotomies for hallux valgus correction such as: • Opening base wedge osteotomy • Closing base wedge osteotomy • Crescentic osteotomy • Proximal Chevron osteotomy • Distal Chevron osteotomy (Austin) -- First metatarsal fracture fixation -- Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion) -- 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 • 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions • lntercuneiform Fusions • Navicular-Cuneiform (NC) Fusion • Talo-Navicular (TN) Fusion • Calcaneo-Cuboid (CC) Fusion -- Medial Column Fusion -- Arthrodesis of the first metatarsophalangeal joint (MTP)

Source page: https://510kreport.com/device/K153531
Methodology: https://510kreport.com/methodology