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Ellipse Intramedullary Limb Lengthening System

by Ellipse Technologies, Inc.

510(k) K101997

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

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 NumberK101997 Date12 Jul 2011ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-0319-2022 FDA Class II initiated 29 Oct 2021

    The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That patients should weigh 50 lbs. or more while undergoing treatment, and (3) That no more than two devices should be implanted at a time.

    • Ongoing Z-1349-2021 FDA Class II initiated 12 Feb 2021

    Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old.

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  • Withdrawn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, 23 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 Ellipse Intramedullary Limb Lengthening System is an orthopedic device designed for limb lengthening procedures. It is an intramedullary system that facilitates the gradual lengthening of bones in the limbs.

This system is supplied as a medical device and is intended for use in orthopedic procedures. It is authorized under FDA 510K clearance with product code HSB. The device is manufactured by Ellipse Technologies, Inc. and is available in various sizes as specified by the manufacturer.

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