# K183321: Treace Medical Concepts (TMC) Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Treace Medical Concepts, Inc.
- Decided: Jan 25, 2019 after 56 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
No predicates in its family tree.
11 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 4 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K143717: Treace Medical Concepts (TMC) Plating System, Treace Medical Concepts, Inc. (2015). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K153531: Treace Medical Concepts (TMC) Plating System, Treace Medical Concepts, Inc. (2016). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K101240: Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467, DePuy Orthopaedics, Inc. (2010). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K090692: Ortholoc 2.0/2.4 Plate System, Wrightmedicaltechnologyinc (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## 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. The system can be used in both adult and pediatric patients. 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-Cubiod (CC) Fusion - Medial Column Fusion - Arthrodesis of the first metatarsophalangeal joint (MTP)

Source page: https://510kreport.com/device/K183321
Methodology: https://510kreport.com/methodology