# K250623: Pediatric Nailing Platform  Tibia Pediatric Nailing Platform  Femur

- Pathway: 510(k) (Special)
- Applicant: OrthoPediatrics Corp.
- Decided: Apr 1, 2025 after 29 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K960642 (1996). 47 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231266: Pediatric Nailing Platform  Tibia, OrthoPediatrics Corp. (2023) Summary page 5.
- K220679: Pediatric Nailing Platform  Femur, OrthoPediatrics Corp. (2022) Summary page 5.
- K172583: OrthoPediatrics PediNail Intramedullary Platform, Orthopediatrics, Inc. (2018) Summary page 5.

## Most influential descendants
- K261345: Pediatric Nailing Platform  Femur (2026), 0 descendants of its own

## Indications for use
Pediatric Nailing Platform | Tibia is intended as a temporary implant for alignment, stabilization and fixation of tibias that have been surgically prepared (osteotomy) for correction of deformities or have sustained fracture due to trauma or disease. The patient population is pediatric and includes child and adolescent subgroups, and small-stature adults - such as patient with small intramedullary canals affected by skeletal dysplasias, osteogenesis imperfecta or other bone diseases. Nail lengths greater than 400mm are for skeletally mature patients. Pediatric Nailing Platform | Femur is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity. Additional indications include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; polytrauma and multiple fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening; fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. The OrthoPediatrics’ Pediatric Nailing Platform | Femur is for single use only.

Source page: https://510kreport.com/device/K250623
Methodology: https://510kreport.com/methodology