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Titanium Cement Restrictor Material PEEK

by Medtronic Sofamor Danek USA, Inc.

510(k) K010528

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)SESU Traditional NumberK010528 Date10 Oct 2001ClearedStatusActive

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  • Withdrawn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
JDK
Device class
Class II
Regulation
21 CFR Part 878.3300
Advisory committee
General, Plastic Surgery
FDA decision
SESU

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a prosthesis, hip, cement restrictor made of titanium and PEEK material. It is a hollow, cylindrical frame with a tapered surface intended for use in hip arthroplasty procedures.

The device is supplied non-sterile and is intended for single use. It is regulated as a Class II medical device under FDA 510(k) clearance K010528, with product code JDK and regulation number 878.3300.

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Questions

AI-generated answers, 19 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 intended use of the Titanium Cement Restrictor Material PEEK device?

    The device is a hollow, cylindrical frame with a tapered surface made of titanium and PEEK material, intended for use in hip arthroplasty procedures as a prosthesis to restrict cement during hip replacement surgery.

  • How is the Titanium Cement Restrictor Material PEEK supplied and is it reusable?

    The device is supplied non-sterile and is intended for single use only, meaning it should not be reprocessed or reused after initial implantation.

  • What regulatory pathway was used for the Titanium Cement Restrictor Material PEEK and what is its classification?

    The device received FDA 510(k) clearance under K010528 and is regulated as a Class II medical device with product code JDK and regulation number 878.3300.