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Nexus(Tm) Femoral Hip Stem

by Dow Corning Wright

510(k) K911052

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 NumberK911052 Date17 Jun 1991ClearedStatusActive

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  • Withdrawn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
JDI
Device Class
Class II
Regulation
21 CFR Part 888.3350
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 NEXUS FEMORAL HIP STEM is an orthopedic device used in hip replacement surgery. It is designed to replace the femoral component of the hip joint, providing structural support and stability for patients requiring hip arthroplasty.

This device is supplied as a single-use implant and is not MRI safe. It is authorized under FDA 510K clearance with product code JDI and is manufactured by Dow Corning Wright. The device is stored according to the manufacturer's instructions and requires appropriate surgical techniques for implantation.

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Questions

AI-generated answers, 23 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 NEXUS FEMORAL HIP STEM used for?

    The NEXUS FEMORAL HIP STEM is an orthopedic device used in hip replacement surgery to replace the femoral component of the hip joint, providing structural support and stability for patients requiring hip arthroplasty.

  • Is the NEXUS FEMORAL HIP STEM reusable or MRI safe?

    The NEXUS FEMORAL HIP STEM is supplied as a single-use implant and is not MRI safe. It should be used only once and requires appropriate surgical techniques for implantation.

  • What is the regulatory status of the NEXUS FEMORAL HIP STEM?

    The NEXUS FEMORAL HIP STEM is authorized under FDA 510K clearance with product code JDI, having been determined substantially equivalent to predicate devices.

  • How should the NEXUS FEMORAL HIP STEM be stored?

    The NEXUS FEMORAL HIP STEM should be stored according to the manufacturer's instructions to maintain its integrity and functionality until use.