# K173930: PYTHON Plate Trial Instruments

- Pathway: 510(k) (Special)
- Applicant: Treace Medical Concepts, Inc.
- Decided: Mar 19, 2018 after 83 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but 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

## 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 * Intercuneiform 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/K173930
Methodology: https://510kreport.com/methodology