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ISKD (Intramedullary Skeletal Kinetic Distractor)

by Orthodyne, Inc.

510(k) K010322

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 · Traditional NumberK010322 Date2 May 2001ClearedStatusActive

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  • Withdrawn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, 18 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 ISKD is an intramedullary device classified as an intramedullary skeletal kinetic distractor, designed for controlled limb lengthening of the tibia and femur. It employs telescoping sections within a single intramedullary nail to achieve gradual elongation through rotational oscillations (3°–9°), eliminating the need for external fixation hardware.

Used in orthopedic surgery, the ISKD is implanted within the medullary cavity of long bones to facilitate limb lengthening in clinical settings. Supplied sterile and intended for single-use, it requires surgical implantation and is regulated under FDA 510(k) clearance (K010322). Compliance with orthopedic surgical protocols ensures proper application, and its design adheres to intramedullary device standards for limb reconstruction.

Questions

AI-generated answers, 18 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 bones is the ISKD designed to lengthen, and how does it achieve this without external fixation?

    The ISKD is specifically designed for controlled lengthening of the tibia and femur. It achieves gradual elongation through telescoping sections within a single intramedullary nail, using rotational oscillations between 3° and 9°. This internal mechanism eliminates the need for external fixation hardware, allowing the bone to lengthen from within the medullary cavity during the healing process.

  • Is the ISKD intended for reuse in multiple patients, or is it meant to be used once and then discarded?

    The ISKD is supplied sterile and explicitly intended for single-use only. After surgical implantation and use in one patient, it should not be reused, as this could compromise sterility and patient safety. The device is designed for one-time application within the medullary cavity.

  • How is the ISKD regulated in the U.S., and what does its FDA clearance status mean for clinicians?

    The ISKD holds an FDA 510(k) clearance (K010322), meaning it has been determined to be substantially equivalent to a legally marketed device already on the market. This clearance confirms that the device meets applicable safety and effectiveness standards for intramedullary skeletal distraction, though clinicians should still follow established orthopedic surgical protocols for proper implantation and use.

  • Are there different sizes or models of the ISKD available, and how would a clinician determine the correct fit for a patient?

    The provided specifications do not list explicit size or model variations for the ISKD, but as an intramedullary device for tibia and femur lengthening, its design must accommodate the anatomical dimensions of these long bones. Clinicians would typically select the appropriate size based on preoperative imaging (e.g., X-rays or CT scans) to ensure proper fit within the medullary cavity, adhering to standard orthopedic sizing guidelines for intramedullary nails.

  • How should the ISKD be stored before use, and what precautions should be taken to maintain its sterility?

    Since the ISKD is supplied sterile, it must be stored in its original, unopened packaging to preserve sterility. The packaging should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. If the sterile barrier is compromised, the device should not be used, and a new sterile unit should be obtained. Always follow manufacturer instructions for storage and handling to prevent contamination.