# K172583: OrthoPediatrics PediNail Intramedullary Platform

- Pathway: 510(k) (Traditional)
- Applicant: Orthopediatrics, Inc.
- Decided: May 10, 2018 after 255 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K982953 (1998). 11 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083726: Pedinail Intramedullary Nailing System, OrthoPediatrics Corp. (2009) Summary page 4.

## Most influential descendants
- K220679: Pediatric Nailing Platform  Femur (2022), 2 descendants of its own
- K250623: Pediatric Nailing Platform  Tibia Pediatric Nailing Platform  Femur (2025), 1 descendant of its own
- K261345: Pediatric Nailing Platform  Femur (2026), 0 descendants of its own
- K190321: Pediatric Nailing PlatformFemur (2019), 0 descendants of its own

## Recalls of this device
- Aug 19, 2019 · Class II · Z-0125-2020: Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures
- Aug 19, 2019 · Class II · Z-0218-2020: Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
- Aug 19, 2019 · Class II · Z-0219-2020: Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.

## Indications for use
The OrthoPediatrics PediNail Intramedullary Platform 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 malunion; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity. Additional indications includes 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 PediNail Intramedullary Platform is for single use only.

Source page: https://510kreport.com/device/K172583
Methodology: https://510kreport.com/methodology