# K200575: Truemed Hand, Foot and Ankle Plates System

- Pathway: 510(k) (Traditional)
- Applicant: Truemed Group, LLC
- Decided: Jul 9, 2021 after 491 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: 13 generations back to K962616 (1996). 109 ancestors in all.
No later device cites it as a predicate yet.
0 of 110 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150099: Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws), Synthes (USA) Products, LLC (2015) Summary page 4.
- K030310: Synthes Stainless Steel Modular Hand System, Synthes (Usa) (2003) Summary page 4.
- K050110: Synthes (Usa) LCP Modular Foot Plates, Synthes (Usa) (2005) Summary page 4.
- K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System, Synthes (Usa) (2010) Summary page 4.
- K071264: Synthes (Usa) 2.4/2.7 MM Locking Foot Module, Synthes (Usa) (2007) Summary page 4.
- K020401: Synthes Calcaneal Plate, Synthes (Usa) (2002) Summary page 4.
- K120854: Synthes VA LCP Ankle Trauma System, Synthes USA (2012) Summary page 4.
- K143191: IntelliSense Drill, Mcginley Innovations (2015) Summary page 4.
- K182650: Arzzt Distal Radius and Ulna System, Truemed Group, LLC (2019) Summary page 4.

## Indications for use
Intended use for fixation of complex intra and extra-articular fractures and osteotomies, selective trauma, reconstructive procedures, fusions osteotomies, non-unions, replantations, complex extra articular fractures and fusions of bones of the anatomical regions of the hand, foot and ankle, particularly for osteopenic bone in adults and adolescents.

Source page: https://510kreport.com/device/K200575
Methodology: https://510kreport.com/methodology