# K190992: OrthoPediatrics PediFoot Deformity Corrections System

- Pathway: 510(k) (Traditional)
- Applicant: OrthoPediatrics Corp.
- Decided: Aug 6, 2019 after 113 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: 10 generations back to K962616 (1996). 100 ancestors in all.
No later device cites it as a predicate yet.
0 of 101 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050110: Synthes (Usa) LCP Modular Foot Plates, Synthes (Usa) (2005) Summary page 4.
- K063049: Synthes (Usa) Modular Mini Fragment LCP System, Synthes (Usa) (2006) Summary page 4.
- K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System, Synthes (Usa) (2010) Summary page 4.
- K131186: Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot System, Synthes (USA) Products, LLC (2013) Summary page 4.
- K001941: Synthes Modular Foot System, Synthes (Usa) (2000) Summary page 4.

## Indications for use
OrthoPediatrics PediFoot Deformity Correction System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments. Examples include, but are not limited to, the hand, wrist, foot, and ankle.

Source page: https://510kreport.com/device/K190992
Methodology: https://510kreport.com/methodology