# K200834: Lever Action Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Mcginley Orthpaedic Innovations, LLC
- Decided: Jun 25, 2020 after 87 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: 1 generation back to K040112 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040112: Trimed Bearing Plate; Trimed Volar Bearing Plate, Tri-Med, Inc. (2004) Summary page 4.

## Indications for use
The Lever Action Plate System is indicated for: 1. Fixation of fractures or non-unions of the distal radius 2. Osteotomies of the distal radius to correct malunion

Source page: https://510kreport.com/device/K200834
Methodology: https://510kreport.com/methodology