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NY R01059




December 10, 2004

CLA-2-30:RR:NC:2:238 R01059

CATEGORY: CLASSIFICATION

TARIFF NO.: 3004.90.9190

Mr. Matthew Piccirilli
Stryker Biotech
35 South Street
Hopkinton, MA 01748

RE: The tariff classification of OP-1 Implant and OP-1 Putty from Ireland

Dear Mr. Piccirilli:

In your letter dated November 11, 2004, you requested a tariff classification ruling.

The first product, OP-1 Implant, is described as follows: “OP-1 Implant is an osteoinductive bone graft material containing recombinant human Osteogenic Protein 1 (OP-1) and bovine derived collagen (ratio is 3.5mg OP-1 to 1g collagen). (OP-1 is also known as bone morphogenetic protein-7 or BMP-7.) OP-1 Implant is provided in a glass vial as a sterile, dry powder in the amount of one gram. The glass vial is sealed with a stopper and a crimp. Each vial is packaged in a thermoform tray and supplied in a box for convenient storage.” OP-1 Implant is indicated for use as an alternative to autograft in recalcitrant long bone nonunions where use of autograft is unfeasible and alternative treatments have failed.

The second product, OP-1 Putty, is described as follows: “OP-1 Putty consists of the recombinant human Osteogenic Protein (rhOP-1), Type 1 Bovine Bone Collagen Matrix (collagen matrix) and the Putty Additive carboxymethyl cellulose sodium (CMC). OP-1 Putty is intended to be reconstituted with sterile saline (0.9%) solution. OP-1 Putty is provided as two components: A large vial containing one gram sterile dry powder consisting of bone collagen and OP-1, (and) A small vial containing the Putty Additive (230 mg) consisting of a sterile dry powder comprised of carboxymethyl cellulose (CMC).” OP-1 Putty is indicated for use as an alternative to autograft in compromised patients requiring revision posterolateral (intertransverse) lumbar spinal fusion, for whom autologous bone and bone marrow harvest are not feasible or are not expected to promote fusion. (Examples of compromising factors include osteoporosis, smoking and diabetes.)

The applicable subheading for both products will be 3004.90.9190, Harmonized Tariff of the United States (HTS), which provides for “Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Other: Other: Other: Other.” The rate of duty will be free.

This merchandise may be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which is administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 1-888-443-6332.

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

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