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PediNail Intramedullary Nailing System

by Orthopediatrics Corp.

510(k) K083726

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

27 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK083726 Date11 Mar 2009ClearedStatusActive

Official records

Recalls

27 recalls · FDA

    • Terminated Z-0879-2017 FDA Class III initiated 18 Nov 2016

    Labeled as a 48mm Cortical Screw but measuring at 50mm

  • 26 recalls, same reason

    • Terminated Z-0341-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0348-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0354-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0353-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0351-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0359-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0352-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0344-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0362-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0343-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-034-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0356-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0346-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0355-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0357-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0339-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0347-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0360-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0358-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0349-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0345-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0363-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0342-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0350-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0364-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009
    • Terminated Z-0361-2010 FDA Unclassified (pre-2012) initiated 21 Jul 2009

    The potential exists for the nails to fracture during insertion of the nail.

Timeline

28 dated events

  1. Recall initiated FDA recalls Z-0360-2010
  2. Recall initiated FDA recalls Z-0358-2010
  3. Recall initiated FDA recalls Z-0349-2010
  4. Recall initiated FDA recalls Z-0345-2010
  5. Recall initiated FDA recalls Z-0363-2010
  6. Recall initiated FDA recalls Z-0342-2010
  7. Recall initiated FDA recalls Z-0350-2010
  8. Recall initiated FDA recalls Z-0364-2010
  9. Recall initiated FDA recalls Z-0361-2010
  10. Recall initiated FDA recalls Z-0879-2017

18 earlier events are in the sections above.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
HSB
Device class
Class II
Regulation
21 CFR Part 888.3020
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The PediNail Intramedullary Nailing System is a pediatric orthopedic device classified as an intramedullary nail, designed for the fixation of femoral fractures and rotational osteotomies in pediatric and adolescent patients. It is anatomically shaped to accommodate the unique anatomy of growing bones, providing stable internal fixation to promote proper alignment and healing.

The system is supplied as a single-use device in diameters of 7, 8, 9, and 10 mm, with lengths ranging from 20 to 38 cm. Implantation is performed via a lateral trochanteric entry point to minimize risks to surrounding vasculature. Authorized for use in the U.S. under FDA 510(k) clearance (K083726), the device is intended for patients aged eight years or older, though clinical discretion may apply.

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