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Modification to ISKD (Intramedullary Skeletal Kinetic Distractor)

by Orthofix, Inc.

510(k) K031219

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 · Special NumberK031219 Date28 May 2003ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0895-2013 FDA Class II initiated 6 Aug 2012

    There is a possibility that the ISKD limb lengthener may stop distracting post-operatively during treatment, which may result in premature bone consolidation (limb not achieving the desired length) leading to revision surgery to remove and/or replace the device.

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  • Withdrawn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, 6 Oct 2026

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

The ISKD is an intramedullary skeletal kinetic distractor designed for limb lengthening of the tibia and femur. It combines internal limb lengthening with external distraction mechanics, offering a telescoping internal limb lengthener and locking screws for gradual distraction.

The device is supplied as part of the ISKD system and is intended for use in orthopedic procedures. It is an internal distraction device, and its regulatory status is documented under FDA 510(k) authorization (K031219).

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Questions

AI-generated answers, 6 Oct 2026

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

  • What is the intended use of the ISKD device?

    The ISKD is an intramedullary skeletal kinetic distractor designed for limb lengthening of the tibia and femur. It combines internal limb lengthening with external distraction mechanics, offering a telescoping internal limb lengthener and locking screws for gradual distraction.

  • How is the device supplied?

    The device is supplied as part of the ISKD system and is intended for use in orthopedic procedures.

  • What is the regulatory status of the device?

    The device's regulatory status is documented under FDA 510(k) authorization (K031219).