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Depuy Synthes Femoral Neck System

by Synthes (USA) Products, LLC

510(k) K182154

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 NumberK182154 Date16 Oct 2018ClearedStatusActive

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  • Withdrawn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
KTT
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Depuy Synthes Femoral Neck System is a device used for femoral neck fractures. It is a dedicated solution designed to address unstable fractures, such as Pauwels III femoral neck fractures. The system provides a means to stabilize and treat these types of fractures. The device is classified under the product code KTT.

The Depuy Synthes Femoral Neck System is supplied by Synthes (USA) Products, LLC. The device has received FDA 510K authorization, indicating it is substantially equivalent to a predicate device. The system is designed for use in orthopedic applications, specifically for the treatment of femoral neck fractures.

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Questions

AI-generated answers, 27 Sep 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 Depuy Synthes Femoral Neck System used for?

    The Depuy Synthes Femoral Neck System is used for the treatment of femoral neck fractures, specifically unstable fractures such as Pauwels III femoral neck fractures.

  • Is the Depuy Synthes Femoral Neck System supplied sterile?

    The description does not specify if the device is supplied sterile, but it is designed for orthopedic applications and has received FDA 510K authorization.

  • What is the regulatory status of the Depuy Synthes Femoral Neck System?

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

  • What type of fractures does the Depuy Synthes Femoral Neck System address?

    The system is designed to address unstable fractures, such as Pauwels III femoral neck fractures, providing a means to stabilize and treat these types of fractures.