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Interpore Cross Cement Restrictor

by Interpore Cross Intl. 510(k)

Active United States

510(k) K032095

Overview

The Interpore Cross Cement Restrictor is a prosthesis, hip, cement restrictor, classified as a resorbable implant manufactured from a polymer-ceramic composite. It is designed to wedge into the medullary canal during joint arthroplasty to prevent cement flow into the canal and allow pressurized filling of the implantation site.

It is intended for use in the femur, tibia, and/or humerus. The device is supplied as a sterile, single-use implant and is regulated under FDA 510(k) clearance K032095, classified as Class II with special controls under product code JDK and regulation number 878.3300.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK032095 Date8 Aug 2003ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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
SESE Substantially Equivalent

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Questions

  • What is the Interpore Cross Cement Restrictor used for?

    It is designed to wedge into the medullary canal during joint arthroplasty to prevent cement flow into the canal and allow pressurized filling of the implantation site, intended for use in the femur, tibia, and/or humerus.

  • How is the Interpore Cross Cement Restrictor supplied and is it reusable?

    The device is supplied as a sterile, single-use implant, meaning it is intended for one-time use only and should not be reprocessed or reused after implantation.

  • What material is the Interpore Cross Cement Restrictor made from and what is its classification?

    It is manufactured from a polymer-ceramic composite and classified as a resorbable implant, falling under the product code JDK and regulation number 878.3300 as a Class II device with special controls.