# K213572: JuniOrtho Plating System™

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix Srl
- Decided: Jan 18, 2022 after 69 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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). 49 ancestors in all.
No later device cites it as a predicate yet.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200246: JPS JuniOrtho Plating System, Orthofix Srl (2020) Summary page 4.
- 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 5.

## 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/K213572
Methodology: https://510kreport.com/methodology