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Elite Modular Hip System

by Thackray USA

510(k) K871867

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 NumberK871867 Date8 Apr 1988ClearedStatusActive

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  • Withdrawn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, 28 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 Elite Modular Hip System is an orthopedic device used for hip replacement procedures. It is a modular system that allows for various configurations to accommodate different patient anatomies.

The device is supplied as a single-use system and is not MRI compatible. It is authorized under FDA 510(k) clearance K871867 with product code JDI, received on May 13, 1987, and cleared on April 8, 1988.

Other devices from Thackray USA

Questions

AI-generated answers, 28 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 ELITE MODULAR HIP SYSTEM used for?

    The ELITE MODULAR HIP SYSTEM is an orthopedic device specifically designed for hip replacement procedures. It is a modular system that allows for various configurations to accommodate different patient anatomies.

  • Is the ELITE MODULAR HIP SYSTEM reusable or single-use?

    The ELITE MODULAR HIP SYSTEM is supplied as a single-use system, meaning it is intended for one patient only and should not be reused or repackaged for another patient.

  • What is the regulatory status of the ELITE MODULAR HIP SYSTEM?

    The ELITE MODULAR HIP SYSTEM is authorized under FDA 510(k) clearance K871867 with product code JDI. It was received on May 13, 1987, and cleared on April 8, 1988.

  • Is the ELITE MODULAR HIP SYSTEM MRI compatible?

    No, the ELITE MODULAR HIP SYSTEM is not MRI compatible. Patients with this implant should avoid MRI scans as the device may interfere with the imaging process.