of the


Hilton Washington, DC North

620 Perry Parkway

Gaithersburg, Maryland

September 9, 2005




Panel Chairperson                                                                                         Executive Secretary

John S. Kirkpatrick, M.D.                                                                            Janet L. Scudiero, M.S.



 8:00       a.m.                Call to Order

                                Panel Introductions

Conflict of Interest


Design of Clinical Studies for

Spinal Devices to Treat Mild to Moderate Low Back Pain


 8:30     a.m.                Open Public Hearing*


                                 Orthopaedic Surgical Manufacturers’ Association

                                                Sally Maher, Esq., President

                                                Hal Matthews, M.D., title, affiliation

                Spine Wave, Inc.

Ronald K. Smith, Director of Quality Systems & Regulatory Affairs

                                                John Pafford, Chief Technical Officer

                Zimmer Spine

                                                Reginald Davis, M.D., Greater Baltimore Medical Center

                                Abbott Spine, Emerging Technologies Research & Development

                                                Paul McAfee, M.D., Towson Orthopedics Association, Baltimore

                                                Brent Blumenthal, Ph.D., TriArc Consulting, Seattle

                            Stryker Spine, Inc.


                                American Association of Neurological Surgeons  


                                North American Spine Society

                                                Marjorie Eskay-Auerbach, M.D., J.D.

                                St. Francis Medical Technologies, Inc.

Paul Anderson, M.D., University of Wisconsin

                                Spine Arthroplasty Society



* Open Public Hearings:  During the open public hearings, interested persons may present data, information, or views, orally or in writing, on the issue pending before the panel.  Scheduled speakers who have requested time to address the panel will speak at this time.  After they have spoken, the Chair may ask them to remain if the panel wishes to question them. Then the Chair will recognize unscheduled speakers as time allows.  Only the panel may question speakers during the open public hearing.



 9:45       a.m.                Break


10:00     a.m.                FDA Presentation

                                                Jonathan H. Peck, Orthopedic Devices Branch


10:30     a.m.                 Panel Deliberation

                                                Lead Discussant, Michael J.Yaszemski, M.D., Ph.D.


FDA Questions  


  1:00      p.m.                Adjournment