# K082375: Orthopediatrics Pediflex Flexible Nail System

- Pathway: 510(k) (Traditional)
- Applicant: OrthoPediatrics Corp.
- Decided: Oct 17, 2008 after 60 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: 4 generations back to K960642 (1996). 9 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081097: Orthopediatrics Pediflex Flexible Nail System, Orthopediatrics, LLC (2008) Summary page 1.
- K971783: Synthes Elastic Intramedullary Nail (Ein) System, Synthes (Usa) (1997) Summary page 1.
- K042135: Synthes (Usa) Elastic Intramedullary Nail (Ein) System (Line Extension), Synthes (Usa) (2004) Summary page 1.
- K053105: Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Synthes (Usa) (2005) Summary page 1.
- K032687: Ace Nancy Nail, DePuy Orthopaedics, Inc. (2003) Summary page 1.
- K000764: Pediatric Fixation Rods, Biomet, Inc. (2000) Summary page 1.
- K081452: Synthes (Usa) Stainless Steel Elastic Intramedullary Nail System, Synthes (Usa) (2008) Summary page 1.
- K063225: Metaizeau Nailing System, Howmedica Osteonics Corp. (2006) Summary page 1.

## Most influential descendants
- K143355: The Simple Locking IntraMedullary (SLIM) System (2015), 6 descendants of its own
- K192710: The Simple Locking Intramedullary (Slim) System (2020), 5 descendants of its own
- K231266: Pediatric Nailing Platform  Tibia (2023), 2 descendants of its own
- K250623: Pediatric Nailing Platform  Tibia Pediatric Nailing Platform  Femur (2025), 1 descendant of its own
- K201838: PediFlex Flexible Nail System (2021), 1 descendant of its own

## Indications for use
The PediFlexTM 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/K082375
Methodology: https://510kreport.com/methodology