The tariff classification of Grafton® Demineralized Bone Matrix (DBM) Allograft Products and Plexur™ P Biocomposite Human Allograft Tissue Products

N056004 April 6, 2009 CLA-2-30:OT:RR:E:NC:2:238 CATEGORY: Classification TARIFF NO.: 3001.90.0190 Mr. Christopher W. Talbot Osteotech, Inc. 51 James Way Eatontown, NJ 07224 RE: The tariff classification of Grafton® Demineralized Bone Matrix (DBM) Allograft Products and Plexur™ P Biocomposite Human Allograft Tissue Products Dear Mr. Talbot: In your letter dated March 26, 2009, you requested a tariff classification ruling. According to you information, Grafton® Demineralized Bone Matrix (DBM) Products and Plexur™ P Biocomposite Human Allograft Tissue Products are produced from, and contain, cadaveric human musculoskeletal (bone and tendon) tissue. They are implanted into defects in patients in surgical/bone grafting procedures to help the patient’s body heal the defects. The products vary in shape, size and composition to meet a variety of surgical needs, depending on the procedure and surgeon preference. All the products are similar in that the key constituent is donated human tissue. The tissue is subjected to a number of processing steps, including cleaning, decontamination and sterilization, to render them suitable for implantation. Grafton® Demineralized Bone Matrix (DBM) Allograft Products are available in a number of forms such as DBM Gel, Flex, A-Flex, Putty Crunch, Orthoblend, Matrix PLF, Matrix Plugs, Matrix Strips, and Paste. They are made of either bone fibers or bone particles, and are packed in various sizes and measured amounts for direct use in surgical procedures. These products provide a biological framework for new bone growth or formation through osteoconductive and/or osteoinductive pathways. Plexur™ P Bone Void Filler Biocomposites are intended for use in filling bony voids or gaps of the skeletal system (i.e., extremities, pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Plexur™ P is resorbed/remodeled and is replaced by host bone during the healing process. Plexur™ P Biocomposite is a bone filler and bone graft extender. It is composed of cortical fibers suspended in a resorbable, porous polylactide-co-glycolide scaffold. It also contains minerals and trace elements, including calcium, phosphate, and extracellular matrix proteins, to promote bone healing. Specially formulated for trauma and reconstructive surgeries, Plexur™ P Bone Void Fillers are available packed in measured amounts or sizes of multiple standard forms – blocks, cylinders, wedges, sheets and granules – for optimal handling. With a spongy consistency much like that of cancellous bone, Plexur™ P wicks blood and packs easily while maintaining shape and porosity. The applicable subheading for the Grafton® Demineralized Bone Matrix and Plexur™ P Human Allograft Tissue Products will be 3001.90.0190, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "Glands and other organs for organotherapeutic uses, dried, whether or not powdered; extracts of glands or other organs or of their secretions for organotherapeutic uses; heparin and its salts; other human or animal substances prepared for therapeutic or prophylactic uses, not elsewhere specified or included: Other: Other." The rate of duty will be free. Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at http://www.usitc.gov/tata/hts/. This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov. This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177). A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Harvey Kuperstein at (646) 733-3033. Sincerely, Robert B. Swierupski Director National Commodity Specialist Division