CLA-2-90:OT:RR:E:NC:N1:105
Ms. Marianne Handel
Synthes USA
1690 Russell Road, Bldg 2
Paoli, PA 19301
RE: The tariff classification of parts of Vertebral Body Stenting Systems from Germany, France, and Switzerland.
Dear Ms. Handel:
In your letter dated January 12, 2009, you requested a tariff classification ruling. No sample was provided.
You state:
“We respectfully request your assistance with the proper classification of the 3 items that will be imported as part of our Vertebral Body Stenting (VBS) system.
VBS is a minimally invasive surgical procedure intended for the reduction of osteoporotic vertebral compression fractures. Once a void is created in cancellous bone in the spine, stents are introduced percutaneously into the vertebral body.
By dilating the Vertebral Body Stent, a cavity is formed inside the vertebral body, allowing cement to be injected. The stent, which remains in the vertebral body after surgery, is intended to be used in combination with legally marketed polymethyl methacrylate (PMMA) bone cement with the proper indications.
The system consists of the noted items, which are discussed at length in the following text:
Vertebral Augmentation Access Kit (Synthes part number 03.804.412S)
VBS Inflation System (Synthes part number 03.804.413S)
Vertebral Body Stent in 2 sizes (Synthes part number 09.804.401S and 09.804.402S)
1. The vertebral Augmentation Access Kit will be manufactured in Germany and imported as part number 03.804.412S, a single-use, sterile blister packaged set of surgical instrumentation. The contents will be imported only as a set, since all included items are required to gain access to the surgical site and to create a channel for the stent. The components of the Access Kit include: 2 guide wires, 2 sleeves, 2 trocars for cannula placement, 2 injection cannulae (side opening) and 2 working cannulae for stent access to the site, and a hand drill and plunger to clear the access created by the cannula...
2. The VBS Inflation System is manufactured in France, and will be imported as part number 03.804.413S, in an individual one-use sterile pack. The kit includes a manometer, along with a 3 way connector. Prior to surgery, stents are connected to the inflation system and filled with saline solution in preparation for use...
3. Vertebral Body Stents, imported from Switzerland, will consist of an implant grade metallic stent, pre-mounted onto a balloon catheter. The stent remains in the vertebral body after surgery...
A summary of the procedure:
Once access is created with the Augmentation Kit, the Vertebral Body Stents are connected to the Inflation System. The stents are inserted through the cannulae and into the vertebral space. Opening the knob on the connector allows flow from the VBS Inflation System into the balloon catheter. The balloons are gradually filled and the stents are expanded to desired height. Once the surgical criteria for stent dilation are met, the balloons are collapsed and removed. The stent remains in the vertebral body, and bone cement is injected into the void. Once the cement has hardened to specification, the working cannulae (from the Augmentation Kit) are removed.”
Regarding the Vertebral Augmentation Access Kit, we agree that one of the HTSUS headings you raise, 9018.90, applies.
Regarding the Inflation System, you propose classification in HTSUS 9026. However, while it contains a manometer, it also has the 3 way connector and other features necessary for it to be an Inflation System. It is sterile packed, which is certainly not the norm for manometers and which is usually indicative of use in the medical sciences, noting the reference to “sterilization” in the Harmonized System Explanatory Note to 9018.
Regarding the Vertebral Body Stents, you propose classification in HTSUS 9021.39. You cite New York Ruling Letter J85317 and other NYRLs concerning other stents. However, those stents were scaffolding for arteries to prevent them from collapsing. The stents here are used in the reduction of compression fractures so they are designed for use in dealing with fractures in the musculoskeletal system. HS EN II to 9021, Splints and other fracture appliances, states:
“Fracture appliances are used either to immobilise injured parts of the body (for extension or protection), or for setting fractures. They are also used in the treatment of dislocations and other joint injuries…
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.”
Therefore, they are not “other than” orthopedic or fracture appliances as you propose.
The applicable subheading for the Vertebral Augmentation Access Kit and the Inflation System will be 9018.90.8000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “other" instruments and apparatus used in medical, surgical, dental, or veterinary sciences, and parts and accessories thereof. The rate of duty will be Free.
The applicable subheading for the Vertebral Body Stents will be 9021.10.0090, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "other" orthopedic or fracture appliances, and parts and accessories thereof. 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