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LPS Limb Preservation System Lower Extremity Dovetail Intercalary

by Depuy, Inc. 510(k)

Active United States

510(k) K041085

Overview

The LPS Limb Preservation System Lower Extremity Dovetail Intercalary is a 3-piece segmental orthopedic implant designed to replace resected bone segments. It consists of a male segment, a female segment, and a connecting pin that are joined via a dovetail connection and secured with a locking pin.

This device is used by orthopedic surgeons in clinical settings for reconstruction following bone loss due to malignant or benign tumors, infection, failed joint replacements, or trauma. The system is supplied as a 55 mm length component and is subject to FDA 510k clearance.

AI-generated from registry data, 21 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK041085 Date22 Jul 2004ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-1820-2013 FDA Class I initiated 11 Jul 2013

    The LPS Lower Extremity Dovetail Intercalary component has the potential for fracture of the female component when exposed to certain physiological loads.

Specification

510(k)

510(k) Number
FDA Product Code
JWH
Device Class
Class II
Regulation
21 CFR Part 888.3560
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the primary clinical purpose of the LPS Dovetail Intercalary?

    This device is designed for orthopedic reconstruction following bone loss. It is indicated for use in cases involving malignant or benign tumors, infection, trauma, or failed joint replacements to restore structural integrity.

  • How is the LPS Dovetail Intercalary system constructed?

    The system is a 3-piece segmental implant consisting of a male segment, a female segment, and a connecting pin. These components are joined using a dovetail connection and are secured in place with a locking pin.

  • What are the available dimensions for this implant?

    The LPS Lower Extremity Dovetail Intercalary is supplied as a 55 mm length component to accommodate specific segmental bone replacement needs.

  • What is the regulatory status of this orthopedic implant?

    The device has received FDA 510k clearance under K041085, having been determined to be substantially equivalent to existing devices for its intended use in orthopedic surgery.