Residual Limb Lengthening System

• • 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-1351-2021 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.

510(k) Number

K141739 ↗

FDA Product Code

HSB

Device Class

Class II

Regulation

21 CFR Part 888.3020

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Ellipse Magec Spinal Bracing and Distraction System Open recall

  Class II

  FDA 510(k) K140178 Active Cleared 27 Feb 2014

• Precice Intramedullary Limb Lengthening System

  Class II

  FDA 510(k) K131677 Active Cleared 11 Oct 2013

• Ellipse Intramedullary Limb Lengthening System Open recall

  Class II

  FDA 510(k) K101997 Active Cleared 12 Jul 2011

• Precice Trauma Nail System

  Class II

  FDA 510(k) K141447 Active Cleared 30 Jun 2014

• Magec Spinal Bracing and Distraction System

  Class II

  FDA 510(k) K141278 Active Cleared 24 Mar 2015

• Ellipse Precice Intramedullary Limb Lengthening System

  Class II

  FDA 510(k) K131490 Active Cleared 23 Jan 2014

See all devices from Ellipse Technologies, Inc. →

• What clinical situation is the Residual Limb Lengthening System intended for?

  It is intended for orthopedic procedures that require lengthening of a residual femoral limb. The telescoping intramedullary nail is implanted in the bone and can be incrementally extended, allowing surgeons to restore length in cases such as post‑amputation reconstruction or congenital shortening.

• How is the system supplied and what components are included?

  The system is supplied sterile as a complete kit. It includes the telescoping intramedullary nail, the necessary locking screws, a set of surgical instruments for implantation, and an external remote controller that enables the clinician to control the distraction process precisely.

• Is the device single‑use or can it be reused?

  The kit is provided sterile for a single surgical implantation. While the nail remains in the patient for the duration of the lengthening course, the packaging and instruments are intended for one‑time use to maintain sterility and ensure consistent performance.

• What regulatory pathway did the device follow for market entry?

  The Residual Limb Lengthening System received FDA 510(k) clearance (K141739) under the traditional clearance type, indicating it was found substantially equivalent to a legally marketed predicate device in the orthopedic category.