Biological Implants Committee

The Biological Implants Committee serves the Academy and the public by reviewing and monitoring scientific and regulatory developments in the field of implantable biologicals, tissue components, and combination biological/biomedical device products as they relate to orthopaedic surgery, care, and practice. The Biological Implants Committee interacts with governmental, regulatory, and standard-setting organizations, as well as orthopaedic device manufacturers to promote the promulgation of safe and efficacious biological products for use in orthopaedics.

Position and Information Statements

• Use of Musculoskeletal Tissue Allografts
• Cell- and Tissue-Engineered Products

Comments and Activities (All in PDF format)

• Draft Guidance on Current Good Tissue Practice and Additional Requirements for Manufactures of Human Cells, Tissues, and Cellular and Tissue-based Products
• Definition of Primary Mode of Action of a Combination Product
• Proposed Rule -  Medicare and Medicaid Programs; Conditions for Coverage for Organ Procurement Organizations
• Draft Reports of the Secretary’s Advisory Committee on Xenotransplantation (SACX)
• Endorsement of the 2006 Revised Uniform Anatomical Gift Act
• Joint Commission Standards Improvement Initiative - Transplantation Safety

Articles

• AAOS Now Publications

Symposia, Courses and Workshops

• Musculoskeletal Allograft Tissue Safety Online Module (Coming Soon)

Scientific Exhibits (All in PDF format)

• 2009
• 2008
• 2007
• 2006

Upcoming Meetings

• 2009
• November 11: Committee Meeting, Atlanta, GA
• 2010
• March (TBD): Committee Meeting, AAOS Annual Meeting, New Orleans, LA
• May 18-21: ASTM F04 May Committee Week, St. Louis, MO
• November 16-19: ASTM F04 November Committee Week, San Antonio, TX
• November (TBD): Committee Meeting, San Antonio, TX

Resources

• Food and Drug Administration (FDA)
• FDA Center for Biologics Evaluation and Research (CBER)
• American Association of Tissue Banks (AATB)
• FDA Orthopaedic and Rehabilitation Devices Panel
• MedWatch
• ASTM

Committee Information

• Charges and Structure
• Member List and Staff Liaison/contact