Committee Accomplishments from October 31, 2001 to October 25, 2002

1. Produced spinal seminar for FDA reviewers on September 27, 2002. Orthopaedic surgeons discussed spinal anatomy, the evolution of spinal devices, vertebroplasty/kyphoplasty, allograft and bone graft substitutes, and test methods and clinical failures.
2. Provided guidance and input to three orthopaedic manufacturer’s 510 (k) applications for antibiotic bone cement preparations. The approval of such an application would be the first product introduced into the U.S. marketplace.
3. Submitted a comment on proposed FDA regulatory reform measures to the HHS Secretary’s Committee.
4. Wrote and provided written & oral testimony for the June 10, 2002 HHS Secretary’s Regulatory Reform Committee meeting.
5. Participated in “Bone Graft Substitutes: The Science, Clinical Application, and Controversies” symposium at the AAOS 2002 Annual Meeting.
6. Facilitating an Internship at the Center for Devices and Radiological Health at FDA to have input on federal orthopaedic programs.
7. Participated in “Wear: From Bench to Bedside” symposium at the AAOS 2002 Annual Meeting.
8. Presented scientific exhibit “Alternative Bearing Surfaces: The Good, Bad and Ugly” at Annual Meeting 2002.
9. Presented scientific exhibit “New Polys for Old: Contribution or Caveat?” at Annual Meeting 2002.
10. Participated in NIH Planning meeting on the NIH Consensus Development Conference on Primary Total Knee Replacement to be held December 2003.

1. The Forum is drafting the “Clinical Trial Design for Hip Replacement Systems” guidance document to submit to the Centers of Devices and Radiological Health/FDA prior to March 2003.
2. Present scientific exhibit at Annual Meeting 2003 entitled “New Polys for Old: Contribution or Caveat?”
3. Present scientific exhibit on antibiotic bone cement with data from the Swedish Hip Registry at Annual Meeting 2003.
4. Presentation by the Acting Director of Cellular and Gene Therapies at FDA to discuss solutions to tissue problems with the Forum.

1. Continue to work with industry on the petition for reclassification of mobile bearing knee components.
2. Continue to facilitate coordination between the Committee on Biological Implants and the Committee on Biomedical Engineering as they address their specific issues and in their interactions with FDA and ASTM.
3. Continued involvement in rewriting revisions to the ISO hip wear standard.
4. ODF website maintained and updated after each meeting.
5. Continue to monitor and review federal legislation and regulatory policies on orthopaedic implants and biological issues.
6. Continued participation with standards organizations, ASTM and ISO.
7. Continued development on a guidance document for the repair of hyaline articular cartilage.

1. Continue to explore opportunities for interaction among multiple federal agencies such as FDA, NIH, and CMS as appropriate to our activities/mission.
2. Development of educational initiatives for orthopaedic surgeons and health professionals to promote the delivery of high quality healthcare and reduce the regulatory burdens.
3. Proceed on the several year plan to provide expertise to industry and FDA on a 510 (k) submission for antibiotic bone cement.
4. Produce federal comments in an effort to decrease the regulatory burden for devices, biological and combination products to enable better patient care.