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Cabling System Trochanter Hook

by Smith & Nephew, Inc.

510(k) K043252

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 NumberK043252 Date14 Jan 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  • Withdrawn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
JDQ
Device class
Class II
Regulation
21 CFR Part 888.3010
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 Cabling System Trochanter Hook is a device used in conjunction with 2.0mm cobalt chrome cables and clamps from the Smith & Nephew Cabling System for trochanteric reattachment whenever the trochanter is osteotomized. It features a single hook for trochanter attachment and a hole for cable routing, designed to prevent proximal migration of the trochanter.

The device is supplied non-sterile and is intended for reusable use. It is used in orthopedic surgical settings, where the cable is routed through the device and around the femur, then tensioned and secured with a clamp. No MRI safety information, storage conditions, or additional authorizations beyond the FDA 510(k) clearance (K043252) are specified in the provided data.

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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 Cabling System Trochanter Hook used for?

    The Cabling System Trochanter Hook is used in conjunction with 2.0mm cobalt chrome cables and clamps from the Smith & Nephew Cabling System for trochanteric reattachment whenever the trochanter is osteotomized, featuring a single hook for attachment and a hole for cable routing to prevent proximal migration of the trochanter.

  • Is the Cabling System Trochanter Hook sterile or non-sterile, and is it reusable?

    The device is supplied non-sterile and is intended for reusable use, meaning it must be cleaned and sterilized by the healthcare facility before each surgical procedure according to their protocols.

  • What components are required to use the Cabling System Trochanter Hook in surgery?

    The Cabling System Trochanter Hook must be used with 2.0mm cobalt chrome cables and clamps from the Smith & Nephew Cabling System, as it is designed specifically to work with these components for trochanteric reattachment procedures.