2005P-0405
CCP 1
Volume 1, 2

Cover Letter

Release Letter

Table of Contents

Classification Questionnaire

Financial Disclosure Statement

Sectlon I - Introduction

Section II - Device Information

Section III - CFR Classification of Metal-on-Metal Semi-constrained Hips

Section IV - Regulatory History of Devices

Section V - Basis for Petition

Section VI - Summary of Testing

Section VII - Published/Unpublished Clinical Results

Section VIII - Medical Device Reports and Adverse Events from the Literature

Section IX - Regulatory Control of Risks

Section X - Devices Currently/Previously Available

Section XI - Conclusion

Appendix 1 - Bibliography

Appendix 2 - Unpublished Reports

Appendix 3 - List of Publications

Volume 2

Relevant Publications Published Material