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NY R04596




September 11, 2006

CLA-2-90:RR:E:NC:N1:105 R04596

CATEGORY: CLASSIFICATION

TARIFF NO.: 3001.90.0000, 9021.10.0050, 9021.39.0000

Ms. Marianne M. Handel
Synthes (USA), Inc.
1690 Russell Road
Paoli, PA 19301

RE: The tariff classification of Vertebral Spacers and other items from Switzerland

Dear Ms. Handel:

In your letter dated August 10, 2006, you requested a tariff classification ruling. No sample was submitted. You did submit a multipage request and about 30 pages of product information.

As we understand your request, the items for which you are requesting classification are:

“The ‘AR Spacer’ is made from a biocompatible radiolucent polymer (polyetheretherketone – PEEK)

The ‘Syncage’, ‘Synex’ and ‘Synmesh’ spacers are made from a biocompatible titanium alloy (Ti-6A1-7Nb). These spacers are hollow, to be filled with allograft (or other bone matter) in the surgical application. Each spacer has related pieces (end caps, rings) that fit securely and complete and ‘filled’ spacer.

We also have several lines (donor bone):
The ‘FRA Spacer’ is constructed of femoral ring allograft, the ‘ACTF and PLIF Spacers’, of cortical allograft, and the ‘CCS Spacer’ of cancellous bone (allograft). They are stocked and shipped as freeze dried.”

“the parts for the titanium alloy spacer (rings and endpieces).”

“the plates, rods and screws used for normal internal fixation (*), subsequent to (and NOT dependent upon) the placement of the spacer.”

You state, ”As you will note, by attached reference materials, each type of spacer is described and marketed as a vertebral body replacement device intended for use in the spine. The spacers are designed to provide spinal column support even in the absence of fusion for a prolonged period.” We do see in the product information that the AR and Synex spacers are referred to as “vertebral body replacement parts”.

Regarding the separately imported parts (rings and endpieces) of the titanium alloy spacers, they are clearly made specifically for the vertebral spacers. They do not appear to be excluded from HTSUS Chapter 90 by its Note 2-a or 1 or by HTSUS Add. US Rule of Interp. 1-c.

Regarding the spacers constructed of donor bone, they are analogous to the items in Harmonized System Explanatory Note D-3 to 3001.

Regarding the “plates, rods, and screws,” it is not clear from the product information which items, if any, would be used subsequent to the placement of the spacer. The items that might fit the general description appear to be used ordinarily independent of the use of a spacer. We do not see anything that is indicated as being designed to attach or secure the spacers. You cite ruling “NY 83364,” which we take to be E83356, 7-8-99, but that concerned items for fractures, for which spacers would not ordinarily be used.

Assuming your question is actually whether we consider the reasoning in Harmonized System Explanatory Note III to 9021 regarding the screws used in the “treatment of fractures” to also apply to the special screws used in, e.g., the USS (Universal Spine System) “Variable Axis Screw Assembly” designed as one of the “Solutions for degenerative lumbar instabilities,” we do also consider them to be classified in 9021 since that is an Orthopedic purpose. We would do likewise for the Buttress Locking Plate, “For anterior buttressing of bone graft following single level discectomies in the lumbosacral spine,” the only item we see called a “Plate” in the product information.

We agree that the applicable subheading for the AR, Syncage, Synex, and Synmesh spacers and the rings and endpieces will be 9021.39.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Other” artificial parts of the body and parts and accessories thereof. The rate of duty will be free.

The applicable subheading for the FRA, ACF, PLIF, and CCS spacers will be 3001.90.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for, inter alia, other human or animal substances prepared for therapeutic or prophylactic uses, not elsewhere specified or included. The rate of duty will be free.

We agree that the applicable subheading for Variable Axis Screw Assembly and the Buttress Locking Plate 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,

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