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DePuy Synthes Femoral Neck System

by DePuy Synthes

510(k) K172872

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 NumberK172872 Date5 Mar 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  • Withdrawn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, 22 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 medical device designed for the treatment of femoral neck fractures. It provides a dedicated solution for addressing fractures in the femoral neck area, which is a common injury in orthopedic cases.

The system is supplied as a single-use device and is not MRI safe. It is authorized under FDA 510K clearance with product code KTT. The device is manufactured by DePuy Synthes and is intended for use in orthopedic procedures as part of a comprehensive orthopedics portfolio.

Other devices from DePuy Synthes

See all devices from DePuy Synthes →

Questions

AI-generated answers, 22 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 designed specifically for the treatment of femoral neck fractures, which are common orthopedic injuries. It provides a dedicated solution for addressing fractures in this particular area of the femur.

  • Is the DePuy Synthes Femoral Neck System reusable or MRI safe?

    The system is supplied as a single-use device and is not MRI safe. After use, it should not be reused on another patient, and it should not be used in MRI environments due to its magnetic properties.

  • What regulatory approvals does the DePuy Synthes Femoral Neck System have?

    The device is authorized under FDA 510K clearance with product code KTT. It received traditional clearance on March 5, 2018, after being submitted on September 21, 2017, with decision code SESE indicating substantial equivalence.

  • How is the DePuy Synthes Femoral Neck System supplied?

    The system is supplied as a single-use device, meaning it comes ready for use in one procedure and should not be reused. It is part of DePuy Synthes' comprehensive orthopedics portfolio and is manufactured in Zuchwil, Switzerland.