CLA-2-90:OT:RR:NC:N4:405
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 spinal inserts from Germany.
Dear Mr. Peterson, and Mr. Semmel:
In your letter, dated January 16, 2012, on behalf of Medtronic Inc., you requested a tariff classification ruling. No samples were provided.
The first category of merchandise consists of Intervertebral Body Fusion Devices. Medtronic has 8 varieties; the Capstone Peek Spinal Fusion System, the Clydesdale Spinal System, the Cornerstone PSR Spinal System, the Crescent Spinal System, the Perimeter Interbody Fusion Device, the Intrepid Spinal System, the Peek Prevail Cervical Interbody Device, and the Sovereign Spinal System.
The second category consists of Spinal Intervertebral Body Fixation Orthoses. Medtronic has 2 varieties; the Hourglass Vertebral Body Spacer, and the Vertestack Spinal System.
The third category consists of the Pedicle Screw Spinal System. Medtronic has one variety; the CD Horizon Spinal System.
All eleven items are inserted into the patient by surgeons to correct deformities of and/or to treat trauma to the spine. Harmonized System Explanatory Note II (Splints and Other Fracture Appliances) to 9021 states, “Subject to the provisions of Note 1 (f) to this Chapter, the heading also includes plates, nails, etc., which are inserted inside the human body by surgeons to hold together the two parts of a broken bone or for similar treatment of fractures.” This applies most closely to the CD Horizon Spinal System, which, you state, “consists of a variety of shapes and sizes of rods, hooks, screws, plates, staples, connecting components, and implant components that which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.”
Regarding the other 10 items, they are more similar to natural vertebrae than the CD Horizon Spinal System is. In New York Ruling Letter R04596 – 105, September 11, 2006, we agreed with the inquirer that various vertebrae spacers were classified as artificial parts of the body in 9021.39.00, which provides for "Other" artificial parts of the body, and parts and accessories thereof.
Headquarters Ruling Letter H003713 - HkP, dated February 22, 2007, noting Note 1-f to Chapter 90, determined that certain screws which, when finished, were intended for use in the fixation of implants were not classified in 9021, HTSUS, but 7318. Without additional information about the screws included in several of these imports, we cannot determine if the screws here are “suitable for use only with” orthopedic appliances or artificial parts of the body. However, in this case, the screws are only one element of each item, and we find that the only heading which describes all the nonsubordinate elements of the imports is 9021, noting the principle in General Electric Company – Medical Systems Group vs. United States, 247 F.3d 1231 (Fed. Cir. 2001).
The applicable subheading for the CD Horizon Spinal System 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.
The applicable subheading for the balance of the merchandise 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.
Regarding all eleven items, we agree with your claim that 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) and that none of the exclusions apply from HTSUS, Chapter 98, Subchapter 17, U.S. Note 4, consistent with previous Headquarters Ruling Letters. Note that the requirement that you 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 Russo
Director
National Commodity Specialist Division