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Precice Intramedullary Limb Lengthening System

by Ellipse Technologies, Inc. 2 variants

510(k) K113219

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK113219 Date19 Oct 2012ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Ellipse Precice Intramedullary Limb Lengthening System
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, 20 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 Precice Intramedullary Limb Lengthening System is an intramedullary device designed for gradual, controlled lengthening of the femur or tibia. It employs a remote-controlled magnetic distraction mechanism to achieve precise, non-invasive elongation of long bones, facilitating surgical correction of limb length discrepancies. The system is intended for orthopedic applications where incremental bone growth is required, such as in congenital or acquired limb deformities. Its design integrates an internal drive mechanism activated externally, eliminating the need for external fixation hardware.

The system is supplied sterile and intended for single-use implantation. It is regulated under FDA 510(k) clearance (K113219) as substantially equivalent to a predicate device, with approval for orthopedic use. Implantation requires surgical placement within the medullary cavity of the femur or tibia, followed by gradual lengthening via an external remote controller. Storage and handling must adhere to sterile medical device protocols. The device is classified under product code HSB and is manufactured by Ellipse Technologies, Inc.

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