CLA-2-90:OT:RR:NC:N4:405

Esequiel Calderon Lanx, Inc.
390 Interlocken Crescent, Suite 890 Broomfield, CO 80021

RE: The tariff classification of the Aspen Surgical Set from the United States

Dear Mr. Calderon:

In your letter dated September 23, 2009, you requested a tariff classification ruling.

The Aspen Surgical Set is used to implant the Aspen Spinous Process System. Your submission describes this system as “a posterior, non-pedicle fixation device for placement in the lumbo-sacral spine. It is designed for plate attachment to spinous processes to achieve supplemental fusion in patients. The system helps to provide immobilization and stabilization for spinal segments as an adjunct to fusion of the lumbar or sacral spine.” The surgical set includes the titanium spinal implants, as well as the instruments required to attach the implants to the patient’s vertebrae. The titanium implants and the instruments for the Aspen system have previously been ruled on in New York Ruling Letter N068586, mailed to you on August 5, 2009, classifying the surgical tools and the implants separately. In this most recent ruling request you express the desire to obtain the classification of the items when shipped together as a set. In a telephone conversation with NISA E. Conceicao you stated that the Aspen Surgical Set consists of the implants and the surgical tools, packaged, shipped, and sold as a set. GRI 3(b) states that sets for retail sale should be classified as if they consisted of the material or component which gives them their essential character, insofar as this criterion is applicable. In your submission you suggest that the Aspen set be classified under HTS 9018.90.8000, in the belief that the surgical tools provide the essential character of the set. Customs has previously taken the position that sets consisting of a medicament or medical implant and the tools to administer them have their essential character imparted by the medicament or implant, even if they do not predominate by bulk, weight, or value of the sets. This can be seen in Headquarters Ruling Letter 962506, December 17, 1999, and New York Ruling Letter J85317, June 25, 2003. In the latter ruling a set consisting of a coated stent and a stent delivery tool was found to have its essential character imparted by the stent. In the case of the Aspen Surgical Set, we believe the essential character is imparted by the titanium spinal implants.

The applicable subheading for the Aspen Surgical Set will be 9021.10.0050, Harmonized Tariff Schedule of the United States (HTSUS), which provides for Orthopedic and fracture appliances, which are Bone plates, screws and nails, and other internal fixation devices or appliances. 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 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 J. Sheridan at (646) 733-3012.

Sincerely,

Robert B. Swierupski
Director
National Commodity Specialist Division