ORTHOPAEDICS AND REHABILITATION DEVICES ADVISORY PANEL
August 8, 2001
Metal on Metal Reclassification Petition
Orthopedic Surgical Manufacturers Association (OSMA)
Disclaimer
The statements contained in this document are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.
September 25, 2000 Cover Memo pdf
Cover Sheet pdf
Table of Contents pdf
Financial Disclosure Statement pdf
Completed Classification Questionnaire pdf
I. Introduction pdf
II. Device Information pdf
III. CFR Classification of Metal/Metal Hip Semi-Constrained Hips pdf
IV. Regulatory History of the Device pdf
V. Basis for Petition pdf
VI. Summary of Testing pdf
VII. Published/Unpublished Clinical Results pdf
VIII. Medical Device Reports (MDRs) pdf
IX. Regulatory Control of Risks pdf
X. Devices Currently/Previously Available pdf
XI. Conclusion pdf
Appendix 1 - Data Summary Tables pdf
Appendix 2 - Bibliography of Published Articles pdf
Appendix 3 - Published Articles *
AMENDMENT 1
Cover Letter pdf
Cover Sheet pdf
Table of Contents pdf
Description of Additional Information pdf
Exhibit 1 - Revised Classification Definitions pdf
Exhibit 2 - Multicenter Studies Data pdf
Appendix 1
Study A Data pdf
Study B Data pdf
Study C Data pdf
Study D Data pdf
Appendix 2 - Companies A-C Clinical, Radiographic, Demographic Tables pdf
Appendix 3 - Revised Display Table 7 pdf
AMENDMENT 2
Cover Letter pdf
Table of Contents pdf
Description of Additional Information
Exhibit 1 Financial Disclosure pdf
Exhibit 2 Data Display Tables 1-8 pdf
Exhibit 3
Study A - Protocol pdf
Study B - Protocol pdf
Study C - Protocol pdf
Exhibit 4 Revised Study C Data Display pdf
Exhibit 5 - Reference Articles *
Exhibit 6 - December 26, 2000 FDA Letter pdf
Exhibit 7 - STM f1714-96 Specifications pdf
AMENDMENT 3 pdf
* This document contains copyrighted material. This material may be viewed at: Dockets Management Branch, Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Maryland 20852, Monday through Friday, 9:00 a.m. through 4:00 p.m. except for Federal Holidays.