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Synthes Lcp Proximal Tibia Plates Line Extension

by Synthes (Usa)

510(k) K052390

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 NumberK052390 Date7 Oct 2005ClearedStatusActive

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  • Withdrawn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)

510(k) Number
FDA Product Code
HRS
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Synthes Lcp Proximal Tibia Plates Line Extension is a metallic bone fixation implant designed for the surgical treatment of proximal tibia fractures and related conditions. It features a limited-contact, low-profile design contoured to match proximal tibia anatomy. The device merges conventional plating techniques with locking screw technology, enabling surgeons to create a fixed-angle construct while using familiar plating techniques.

The Synthes Lcp Proximal Tibia Plates Line Extension is available in left and right configurations with shaft lengths from 298 mm to 370 mm and 16 to 20 shaft holes, and in 3.5- and 4.5-mm sizes. It is supplied for use in orthopedic procedures and has received FDA 510K authorization. The device is intended for use in the treatment of fractures of the proximal tibia in adults and adolescents in which the growth plates have fused.

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Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Synthes LCP Proximal Tibia Plates Line Extension used for?

    The Synthes LCP Proximal Tibia Plates Line Extension is used for the surgical treatment of proximal tibia fractures and related conditions in adults and adolescents with fused growth plates.

  • What sizes and configurations are available?

    The device is available in left and right configurations, with shaft lengths from 298 mm to 370 mm, 16 to 20 shaft holes, and in 3.5- and 4.5-mm sizes.

  • Is the Synthes LCP Proximal Tibia Plates Line Extension supplied sterile?

    The description does not explicitly state that the device is supplied sterile, but it is intended for use in orthopedic procedures.

  • What is the regulatory status of the Synthes LCP Proximal Tibia Plates Line Extension?

    The device has received FDA 510K authorization, indicating that it is substantially equivalent to a predicate device.