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Synthes (USA) Trochanter Stabilization Plate for DHS

by Synthes (Usa) 510(k)

Active United States

510(k) K000972

Overview

The Synthes (USA) Trochanter Stabilization Plate for DHS is an appliance, fixation, nail/blade/plate combination, multiple component, metal composite device intended for use in orthopedic applications. It is designed to stabilize the greater trochanter during fracture fixation when used with the Dynamic Hip Screw (DHS) system.

This device is supplied as part of an instrument and implant set and is indicated for temporary fixation, correction, or stabilization of bones in the femur, specifically for stable and unstable intertrochanteric, subtrochanteric, pertrochanteric, and basilar neck fractures. It is a reusable device, not sterile, and is regulated under FDA 510(k) clearance K000972 with product code LXT and regulation number 888.3030.

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

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK000972 Date16 Jun 2000ClearedStatusActive

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

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

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

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Questions

  • What is the Synthes (USA) Trochanter Stabilization Plate for DHS used for?

    It is intended for use in orthopedic applications to stabilize the greater trochanter during fracture fixation when used with the Dynamic Hip Screw (DHS) system, specifically for stable and unstable intertrochanteric, subtrochanteric, pertrochanteric, and basilar neck fractures of the femur.

  • Is the Synthes (USA) Trochanter Stabilization Plate for DHS sterile or single-use?

    The device is not sterile and is designed as a reusable device, meaning it can be cleaned and reused after appropriate reprocessing in accordance with the manufacturer's instructions.

  • How is the Synthes (USA) Trochanter Stabilization Plate for DHS supplied?

    It is supplied as part of an instrument and implant set, meaning it is provided alongside other components necessary for use with the Dynamic Hip Screw system during surgical procedures.

  • What regulatory pathway was used for the Synthes (USA) Trochanter Stabilization Plate for DHS?

    The device was cleared through the FDA 510(k) process under clearance number K000972, with product code LXT and regulation number 888.3030, indicating it was found substantially equivalent to a legally marketed predicate device.