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  Published/Unpublished Clinical Results   pdf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.