# K221181: Treace Medical Concepts (TMC) Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Treace Medical Concepts, Inc.
- Decided: Jan 5, 2023 after 255 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: 15 generations back to K954385 (1996). 98 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220136: Treace Medical Concepts (TMC) Plating System, Treace Medical Concepts, Inc. (2022) Summary page 4.
- K181872: MIS Bunion System, Crossroads Extremity Systems, LLC (2019) Summary page 4.
- K101962: Mini Maxlock Extreme Plating System, Orthohelix Surgical Designs, Inc. (2010) 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
- K233154: SkyOPS™ Orthopedic Plate System (2023), 1 descendant 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 the feet. The system can be used in both adult and pediatric patients aged >12 years. In the foot, the system can be used for the following specific examples: * Osteotomy of the 1st metatarsal for the treatment of deformity (e.g., hallux valgus) 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 - Intercuneiform Fusions - Navicular-Cuneiform (NC) Fusion - Talo-Navicular (TN) Fusion - Calcaneo-Cuboid (CC) Fusion » Medial Column Fusion

Source page: https://510kreport.com/device/K221181
Methodology: https://510kreport.com/methodology