# K162307: OrthoPediatrics Locking Proximal Femur System Cortical Screws

- Pathway: 510(k) (Special)
- Applicant: OrthoPediatrics Corp.
- Decided: Sep 27, 2016 after 41 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). 64 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111086: Orthopediatrics Fracture and Osteotomy Bone Plate System, OrthoPediatrics Corp. (2011) Summary page 4.

## Most influential descendants
- K243963: Pediatric Plating Platform  Hip (2025), 0 descendants of its own

## Indications for use
The OrthoPediatrics Locking Proximal Femur System Cortical Screws are intended for temporary internal fixation and stabilization of long bone fractures and osteotomies, mal-unions, and non-unions, in pediatric and small stature adults. Specific indications include: intertrochanteric derotation and Varus osteotomies, femoral neck and pertrochanteric fractures, and intertrochanteric valgus osteotomies.

Source page: https://510kreport.com/device/K162307
Methodology: https://510kreport.com/methodology