# K200246: JPS JuniOrtho Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix Srl
- Decided: May 22, 2020 after 112 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: 9 generations back to K962616 (1996). 48 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112085: Synthes LCP Pediatric Plate Systems, Synthes (USA) Products, LLC (2011) Summary page 4.
- K100240: Orthopediatrics Pediloc Tibia Plate System, OrthoPediatrics Corp. (2010) Summary page 4.

## Most influential descendants
- K213572: JuniOrtho Plating System™ (2022), 0 descendants of its own

## Indications for use
The JPS JuniOrtho Plating System™ is intended for internal fixation and stabilization of fractures, osteotomies, mal-unions and non-unions of long bones of the lower limb. The JPS JuniOrtho Plating System™ is indicated for internal fixation and stabilization of femoral and tibial fractures, osteotomies, mal-unions and non-unions. Indications include: - Varus, valgus, rotational and/or shortening osteotomies - Femoral neck and/or pertrochanteric fractures - Proximal and distal metaphyseal fractures - Pathological and impeding pathological fractures Use of the JPS JuniOrtho Plating System™ is indicated in pediatric (excluding newborns) and small stature adult patients.

Source page: https://510kreport.com/device/K200246
Methodology: https://510kreport.com/methodology