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Long Trochanteric Nail System

by Depuy Orthopaedics, Inc.

510(k) K013563

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

54 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK013563 Date27 Dec 2001ClearedStatusActive

Recalls

54 recalls · FDA

  • 11 recalls, same reason

    • Terminated Z-1226-2018 FDA Class II initiated 20 Dec 2017
    • Terminated Z-1234-2018 FDA Class II initiated 20 Dec 2017
    • Terminated Z-1231-2018 FDA Class II initiated 20 Dec 2017
    • Terminated Z-1227-2018 FDA Class II initiated 20 Dec 2017
    • Terminated Z-1229-2018 FDA Class II initiated 20 Dec 2017
    • Terminated Z-1233-2018 FDA Class II initiated 20 Dec 2017
    • Terminated Z-1225-2018 FDA Class II initiated 20 Dec 2017
    • Terminated Z-1228-2018 FDA Class II initiated 20 Dec 2017
    • Terminated Z-1230-2018 FDA Class II initiated 20 Dec 2017
    • Terminated Z-1232-2018 FDA Class II initiated 20 Dec 2017
    • Terminated Z-1235-2018 FDA Class II initiated 20 Dec 2017

    Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system.

  • 43 recalls, same reason

    • Terminated Z-0394-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0398-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0458-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0399-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0401-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0400-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0411-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0457-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0459-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0408-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0392-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0416-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0407-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0456-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0397-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0412-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0462-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0405-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0404-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0417-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0460-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0396-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0419-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0414-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0454-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0395-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0393-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0451-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0415-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0418-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0450-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0406-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0391-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0402-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0390-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0455-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0453-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0413-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0403-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0452-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0409-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0410-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003
    • Terminated Z-0461-04 FDA Unclassified (pre-2012) initiated 11 Dec 2003

    The lag screw may migrate to the femoral head or into the abdominal cavity.

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

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 Long Trochanteric Nail System is an orthopedic intramedullary device designed for the fixation of complex femoral fractures. It provides stable internal support for pertrochanteric, subtrochanteric, and diaphyseal fractures, including pathological fractures in osteoporotic bone, non-unions, malunions, and revision cases.

This device is supplied as a reusable surgical implant and is intended for use in orthopedic procedures under sterile conditions. It is classified under product code HSB and has received FDA 510(k) clearance through the Traditional pathway. The system is not MRI-safe and must be handled according to standard orthopedic implant protocols.

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Questions

AI-generated answers, 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.

  • What types of femoral fractures is the Long Trochanteric Nail System specifically designed to address in clinical practice?

    The Long Trochanteric Nail System is designed for fixation of complex femoral fractures, including pertrochanteric, subtrochanteric, and diaphyseal fractures. It is also indicated for pathological fractures in osteoporotic bone, as well as non-unions, malunions, and revision cases where stable internal support is required.

  • Is the Long Trochanteric Nail System intended for single-use or can it be reused in multiple procedures?

    The Long Trochanteric Nail System is explicitly described as a reusable surgical implant. It must be handled under sterile conditions during each use, adhering to standard orthopedic implant protocols for reprocessing and sterilization.

  • Can this device be used in patients who require MRI scans after implantation, or does it pose any restrictions?

    The Long Trochanteric Nail System is not MRI-safe. Patients implanted with this device should avoid MRI procedures, as the device could pose risks during imaging. Standard orthopedic implant protocols must be followed for monitoring and follow-up care.

  • How is the Long Trochanteric Nail System supplied, and what considerations should clinicians keep in mind during storage?

    The system is supplied as a reusable orthopedic intramedullary implant, meaning it is intended for multiple uses with proper sterilization between procedures. Clinicians should store it in a clean, dry environment following manufacturer guidelines to maintain sterility and integrity before use, ensuring compliance with orthopedic implant handling protocols.