Skip to content

Dimension Revision Total Hip System

by Kirschner Medical Corp. 510(k)

Active United States

510(k) K895636

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SN Traditional NumberK895636 Date14 Dec 1989DecidedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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
JDI
Device Class
Class II
Regulation
21 CFR Part 888.3350
Advisory Committee
Orthopedic
FDA Decision
SN

Overview

AI-generated summary, 6 Oct 2026

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

The Dimension Revision Total Hip System is a prosthetic device designed for hip replacement procedures. It functions as a total hip system to replace the hip joint during revision surgery.

This device is identified by FDA 510(k) number K895636 and was cleared for use on December 14, 1989. It is manufactured by Kirschner Medical Corp. and is classified under the orthopedic product code JDI.

Other devices from Kirschner Medical Corp.

See all devices from Kirschner Medical Corp. →

Questions

AI-generated answers, 6 Oct 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 primary clinical purpose of the Dimension Revision Total Hip System?

    The Dimension Revision Total Hip System is a prosthetic device specifically engineered for use in hip replacement procedures, particularly for patients undergoing revision surgery to replace the hip joint.

  • What is the regulatory history and manufacturer of this hip system?

    This device is manufactured by Kirschner Medical Corp. and is identified in regulatory records by FDA 510(k) number K895636, which was cleared for use on December 14, 1989.

  • How is the Dimension Revision Total Hip System classified for regulatory purposes?

    The system is classified under the orthopedic product code JDI, which is used to categorize specific prosthetic hip components within the regulatory framework managed by the Orthopedic advisory committee.