Dimension Revision Total Hip System
by Kirschner Medical Corp. 510(k)
Active
510(k) K895636
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SN | NumberK895636 | Date14 Dec 1989 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 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
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.
Questions
AI-generated answers, 6 Oct 2026
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.