CLA-2-90:OT:RR:NC:4:405
John M. Peterson
Russell A. Semmel
Neville Peterson, LLP
Counsellors at Law
17 State Street – 19th Floor
New York, New York 10004
RE: The tariff classification of kyphoplasty instruments from Switzerland.
Dear Mr. Peterson, and Mr. Semmel:
In your seventeen page letter, plus attachments, dated January 4, 2012, on behalf of Medtronic Inc., you requested a tariff classification ruling. No samples were provided.
You state the merchandise consists of certain surgical instrument kits for performing “balloon kyphoplasty,” a surgical procedure to treat people suffering from spinal fracture as a result of osteoporosis.
You also state kyphoplasty involves the injection of bone cement through working cannulae into the compressed portion of a vertebra to stabilize the fracture. To perform balloon kyphoplasty, a small orthopedic balloon is first inserted into the fractured vertebra through the cannulae and inflated, to restore the height of the vertebra; the bone cement is injected into the space created by the balloon after it is deflated and removed. The instruments comprising the balloon kyphoplasty kits are various syringes, needles, and cannulae, including: an “osteo introducer,” a needle with a working cannula and capped with a drill tip to create percutaneous access and a channel to the vertebral body; a bone biopsy needle with a plunger to collect specimens; a curette to scrape and score cancellous bone; a bone tamp to create a void and compact cancellous for spinal fracture reduction; an inflation syringe to apply the balloon; a bone filler syringe to inject the bone cement; and a bone access needle to position and to support the other instruments.
Per www.mayoclinic.org/vertebroplasty/kyphoplasty.html, kyphoplasty is described:
“Similar to vertebroplasty, kyphoplasty may be used on patients with compression fractures in the spine. Kyphoplasty offers the potential to restore bone height in the vertebra and reverse deformity of the spine. Mayo Clinic offers both treatments, allowing specialists to choose the correct treatment for each patient.
As in vertebroplasty, a patient undergoing kyphoplasty lies face down. The physician advances a thin tube into the fractured vertebra from an incision in the back. Through the tube, the physician drills a small hole through the hard, outer part of the bone and into its softer center. This provides a pathway for the physician to insert a special balloon into the interior of the vertebra, which is then inflated. This pushes apart the caps, or end plates, of the fractured vertebra, and restores the vertebra to its original shape as much as possible. The balloon is then deflated and removed, leaving a cavity that the physician fills with bone cement.”
You propose classification Harmonized Tariff Schedule of the United States (HTSUS) 9018.90.80. We agree that all the items in the kit are classifiable in HTSUS 9018. However, in this case, we find that the essential character of the kit is given by the items which are classifiable in the singly indented description above HTSUS 9018.31 through .39, noting General Rule of Interpretation 3-b. Within that description, we find 9018.32 to be the last subheading which equally merits consideration in giving the kit’s essential character, noting General Rule of Interpretation 3-c.
You propose a possible (secondary) classification of these items under HTSUS 9817.00.96 as articles for the handicapped.
While osteoporosis is routinely symptom free, kyphoplasty is an invasive medical procedure which is used in the treatment of compression fractures of the spine for which the underlying cause is usually, but not always, severe osteoporosis. Those suffering for the level of spinal degeneration that would cause them to undergo kyphoplasty would presumably be suffering from a permanent or chronic physical impairment which substantially limits one or more major life activities per Chapter 98, Subchapter 17, U.S. Note 4(a), HTSUS.
Although kyphoplasty is usually referred to as therapeutic or as a treatment, e.g., on the Mayo Clinic website cited above, it is not excluded as a therapeutic article via Chapter 98, Subchapter 17, U.S. Note 4(b)(iii), HTSUS, as interpreted by, e.g., Headquarters Ruling Letter 561940 KSG, February 7, 2001.
The applicable subheading for the kyphoplasty kit will be subheading 9018.32.00, HTSUS, which provides for "[I]nstruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments; parts and accessories thereof: Syringes, needles, catheters, cannulae and the like; parts and accessories thereof: Tubular metal needles and needles for sutures and parts and accessories thereof. The rate of duty will be free.
A secondary classification will apply in HTSUS 9817.00.96 as specially designed or adapted for the use or benefit of the permanently or chronically physically or mentally handicapped (except articles for the blind). The requirement that the importer prepare and file a U.S. Department of Commerce form ITA-362P has been eliminated via a notice from the International Trade Administration, published in the Federal Register of June 1, 2010. This merchandise is already duty free, but if you elect to claim the secondary classification in Chapter 98 of 9817.00.96 and meet the entry requirements, no merchandise processing fee will apply to those importations even if they are non-NAFTA, noting, e.g., Headquarters Ruling Letter 229110 IDL, 8-29-02. Also note that this classification has no effect on any quota, visa, or restricted merchandise requirements.
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,
Thomas J. Russo
Director
National Commodity Specialist Division