# K231266: Pediatric Nailing Platform  Tibia

- Pathway: 510(k) (Traditional)
- Applicant: OrthoPediatrics Corp.
- Decided: Aug 21, 2023 after 111 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: 7 generations back to K960642 (1996). 38 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192710: The Simple Locking Intramedullary (Slim) System, Pega Medical, Inc. (2020) Summary page 4.
- K160545: Gap Endo-Exo Medullary System, Pega Medical, Inc. (2016) Summary page 4.
- K150867: Affixus Tibial Nailing System, Biomet, Inc. (2015) Summary page 4.

## Most influential descendants
- 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

## Indications for use
The 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, including 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.

Source page: https://510kreport.com/device/K231266
Methodology: https://510kreport.com/methodology