Committee Accomplishments from October 31, 2000 to October 31, 2001

1. Publication of "Implant Wear" following the AAOS/NIH Wear 2000 Wear symposium. (Editors: Timothy Wright, PhD & Stuart Goodman, MD, PhD)
2. AAOS Washington Office held a meeting with HHS Secretary Thompson's office to discuss the provisions of the single-use device (SUD) enforcement guidance document. Subsequently, the deadline for enforcement of Class II devices was delayed.
3. Forum members provided input into the AAOS position statement on the use of reprocessed single-use devices.
4. AAOS/Forum members filed two formal comments on reprocessed single-use devices with the FDA.
5. Participated in symposium on cross-linked polyethylenes at May ASTM 2001 meeting.
6. Participated in the Bone Graft Substitutes symposium at the November 2000 ASTM meeting.
7. Forum members participated in drafting the formal comment to the FDA on Good Tissue Practices.
8. Forum members gave input to the formal AAOS comment on the reclassification of the hip joint metal/polymer constrained cemented or uncemented prosthesis.

1. Participation in Wear: From Bench to Bedside symposium at the AAOS 2002 Annual Meeting.
2. Participation in Bone Graft Substitutes: The Science, Clinical Application, and Controversies symposium at the AAOS 2002 Annual Meeting.
3. Participation in scientific exhibits Alternative Bearing Surfaces: The Good, Bad & Ugly and New Polys for Old: Contribution or Caveat? at AAOS 2002 Annual Meeting.
4. Participated in spinal implants symposium at ASTM meeting in November 2001.
5. The Forum had a formal presentation from David Feigal, MD, MPH, Director of the Center for Devices and Radiological Health (CDRH).

1. AAOS filed a comment on Regulatory Reform measures, including FDA issues with the Health and Human Services Secretary, Tommy Thompson.
2. AAOS is requesting time to provide testimony at the June 10-11, 2002 Regulatory Reform meeting to discuss problems with new technology development, specifically orthopaedic devices.
3. The Forum has developed a new technologies subcommittee to evaluate and provide recommendations to FDA on educational efforts and new technology approvals.
4. 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.
5. Continued involvement in rewriting revisions to the ISO hip wear standard.
6. ODF website maintained and updated after each meeting.
7. Continue to monitor and review federal legislation and regulatory policies on orthopaedic implants and biological issues.
8. Revising the reclassification petition for metal/metal semi-constrained hip joint prosthesis.
9. Forum members have formed a subcommittee to consider pre-market/post-market time frame possibilities.
10. Facilitating efforts of the Biological Implants committee to participate in ASTM standards and testing methods development for biological tissues.
11. Continued participation with standards organizations ASTM and ISO.
12. Forum members have identified pathways for possible 510k submissions of antibiotic bone cements and will focus on encouraging rapid submission of such 510ks.
13. Forum members are working with industry to develop guidance documents for performance standards for total hip and total knee implants. This has the potential to substantially accelerate product introduction where incremental changes are being made.

1. Continue to expand interactions with CMS as they relate 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.
2. Continue to develop reclassification petitions for mobile bearing prostheses.
3. Continue to explore opportunities for interaction among multiple federal agencies such as FDA, NIH, and CMS as appropriate to our activities/mission.
4. Anticipate submission of the repair of hyaline articular cartilage guidance document to the FDA.