Committee Accomplishments from
October 31, 1999, through October 31, 2000

1. The ODF initiated a NIH sponsored workshop entitled "Wear Workshop 2000" in October 2000. Members participating as faculty: Timothy Wright, PhD (Principal Investigator), Bernard Stulberg, MD, Joshua Jacobs, MD, Seth Greenwald, D. Phil, James Panagis, MD, and Barbara Boyan, PhD.
2. ODF members, Timothy Wright, PhD, Ken De Haven, MD, Bernard Stulberg, MD, Jack Parr, PhD, James Panagis, MD, Jack Lemons, PhD participated as faculty in the NIH Technology Assessment Conference on "Improving Implant Performance through Retrieval Information: Opportunities and Challenges" in January 2000.
3. The ODF initiated the clinical trials courses at the ORS Annual Meeting 2000 under the auspices of Barbara Boyan, PhD.
4. The ODF initiated the December 2000 AAOS Clinical Trials course and members will comprise part of the faculty.
5. The ODF had a formal presentation from Center for Devices and Radiological Health (CDRH) Director, David Feigal, MD.
6. Participation in the November 1999 Symposium "Synthetic Bioabsorbable Polymers for Implants" of the American Society for Testing and Materials (ASTM) in Kansas City.
7. Participation in the May 2000 Symposium "History of ASTM- F-04 Medical, Surgical Division" in Toronto, Canada.

1. Disclosure is routine for ODF members.
2. Organizational issues of ODF have been resolved.
3. Two new forums, Plastics and Reconstructive Surgery and Neurosurgery, have been formed as a result of the success of the ODF in its efforts to develop meaningful dialog among industry, FDA and related specialty societies. The ODF model has been promoted by the FDA to these societies. Frequent and expanded interaction among these groups (now totaling 3) is expected, as issues of interest/importance overlap. This substantially reduces the risk of participation to the AAOS, satisfying one of the goals of the ODF reorganization.
4. Participated in the open public FDA meeting, " Human Bone Allograft: Manipulation and Homologous Use in Spine and Other Orthopedic Reconstruction and Repair."

1. Letters appropriate to supporting reclassifications were written on behalf of the AAOS.
2. Cartilage guidance has been developed and will be submitted to the Center for Biologics, Evaluation, and Research (CBER) for future revisions.
3. Reclassification of shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis (without this reclassification a new PMA/IDE would be necessary, and fewer product types would be available in the marketplace).
4. Reclassification petition of metal/metal semi-constrained hip joint prosthesis submitted to FDA in Sept. 2000.
5. Developed Bone Graft guidance in conjunction with ASTM.
6. Bone Graft guidance to be completed and forwarded to FDA/CBER in early April 2001.
7. Entire new effort to develop standards for tissue engineered products and biologics has been fostered through ASTM and subsequently, the International Standards Organization (ISO). These are industry leading standards development activities. The AAOS and the orthopaedic scientific community/industry have had substantial input into this process. The interaction with the ASTM in this Forum led to the initiation of this standards development process.

1. Fostered development of the bone graft workshop at ASTM in November 2000.
2. Present symposium "Technology 2001- Alternative Bearing Surfaces: The Good, Bad and Ugly" at Annual Meeting 2001.
3. Participated in the Bone Graft Substitutes symposium at the November 2000 ASTM meeting.

1. Continued involvement in ISO in writing revisions to their hip wear simulator testing standard.
2. Restructured ODF to ensure productivity and communication.
3. Facilitating efforts of the Biological Implants committee to participate in ASTM standards and testing methods development for biological tissues.
4. ODF website maintained and updated after each meeting.
5. Pursue reclassification of mobile bearings.
6. Implement succession plan for constituent societies.
7. Continue to monitor and review federal legislation and regulatory policies on orthopaedic implants and related issues.
8. Continue to expand interactions with HCFA as it relates to policy coverages for new technologies. This will be particularly important to the identification of new mechanisms to move new technologies to the populations that can benefit from them.

1. ODF members are pursuing post market surveillance opportunities with the FDA Office of Surveillance and Biometrics in long-term post market studies.
2. Continue to develop reclassification petitions of mobile bearing prostheses.
3. Finalize Cartilage guidance and Bone Graft guidance and send to CBER.
4. Continue to explore opportunities for interaction among multiple federal agencies such as FDA, NIH, and HCFA as appropriate to our activities/mission.
5. 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 outside interactions with FDA and ASTM.