# K190321: Pediatric Nailing PlatformFemur

- Pathway: 510(k) (Special)
- Applicant: OrthoPediatrics Corp.
- Decided: Oct 9, 2019 after 238 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: 4 generations back to K982953 (1998). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172583: OrthoPediatrics PediNail Intramedullary Platform, Orthopediatrics, Inc. (2018) Summary page 4.

## Indications for use
The OrthoPediatrics 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 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 Pediatric Nailing Platform|Femur is for single use only.

Source page: https://510kreport.com/device/K190321
Methodology: https://510kreport.com/methodology