# K243963: Pediatric Plating Platform  Hip

- Pathway: 510(k) (Traditional)
- Applicant: OrthoPediatrics Corp.
- Decided: Apr 29, 2025 after 127 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: 14 generations back to K962616 (1996). 239 ancestors in all.
No later device cites it as a predicate yet.
0 of 240 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162307: OrthoPediatrics Locking Proximal Femur System Cortical Screws, OrthoPediatrics Corp. (2016) Summary page 5.
- K111086: Orthopediatrics Fracture and Osteotomy Bone Plate System, OrthoPediatrics Corp. (2011) Summary page 5.
- K210837: Smith & Nephew Plates and Screws, Smith & Nephew, Inc. (2021) Summary page 5.
- K993289: Smith & Nephew Compression Hip Screw System, Intramedullary Hip Screw System, Smith & Nephew, Inc. (1999) Summary page 5.
- K072095: Synthes (Usa) Pediatric LCP Hip Plate System Modifications, Synthes (Usa) (2007) Summary page 5.

## Indications for use
The Pediatric Plating Platform | Hip is intended for temporary internal fixation and stabilization of proximal femur fractures and osteotomies, mal-unions and non-unions, in pediatric and small stature adults.

Source page: https://510kreport.com/device/K243963
Methodology: https://510kreport.com/methodology