# K201838: PediFlex Flexible Nail System

- Pathway: 510(k) (Traditional)
- Applicant: OrthoPediatrics Corp.
- Decided: Jan 29, 2021 after 211 days
- Product code: HTY (Pin, Fixation, Smooth)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K960642 (1996). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082375: Orthopediatrics Pediflex Flexible Nail System, OrthoPediatrics Corp. (2008) Summary page 4.
- K081097: Orthopediatrics Pediflex Flexible Nail System, Orthopediatrics, LLC (2008) Summary page 4.

## Most influential descendants
- K251362: PediFlex™ Flexible Nail System (2025), 0 descendants of its own

## Indications for use
The PediFlex™ Flexible Nail System is intended for fixation of diaphyseal fractures of long bones where the medullary canal is narrow or flexibility of the implant is required. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small stature patients. In pediatric patients, the flexibility of the nail allows it to be inserted at a point that does not disturb or disrupt the growth plate.

Source page: https://510kreport.com/device/K201838
Methodology: https://510kreport.com/methodology