CLA-2-90:OT:RR:NC:2:235
Mr. Alexander M. Van Ruler
Synthes
1302 Wrights Lane East
West Chester, PA 19380
RE: The tariff classification RapidSorb Injectable Polymer System (IPS) from Germany or Switzerland
Dear Mr. Van Ruler:
In your letter dated June 27, 2014, you requested a tariff classification ruling.
The instant products for which you requested a classification ruling are as follows:
1) RapidSorb IPS Power Drive Unit - Synthes part number 530.551;
2) RapidSorb IPS Implant Cartridges - Sterile - Synthes part numbers 805.505.01S, 805.510.01S and 805.520.01S;
3) RapidSorb IPS Delivery Device Starter Kit - Sterile - Synthes part number 805.550.01S.
The RapidSorb IPS system is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations. The system is made up of a sterile delivery device and sterile cartridges that contain a polymer. The polymer from the cartridges is used to create fasteners for the fixation of plates, meshes and sheets to bone. The polymer is heated, a hole is drilled in the bone to accept a fastener, and a hole in the support structure is aligned with the hole in the bone. The heated polymer is expelled into the holes. The polymer then remains fastened to the bone and holds the adjacent support structure in place. You indicate that the implant delivery system is a novel alternative to screws or tacks featuring a cordless design, select a size adjustability, multi-load functionality, and easy to follow technique.
You provide the following overview of each of the components:
1) The RapidSorb IPS Power Drive Unit (530.551) is cordless and battery operated. This component provides the power to heat the cartridge contents, thus creating the required fastener. The drive unit is reusable and non-sterile. Prior to a surgical procedure, the drive unit is encased in the single use delivery device and powered by a lithium manganese dioxide primary battery. The Power Drive Unit is specific to use in a surgical setting. You indicate that the drive unit this unit uses is similar to the one reviewed in NY Ruling Number M86814, in that it uses electricity to power its function, and should therefore be considered "electro-medical". The RapidSorb IPS Power Drive Unit only provides the power from the battery to the heating element, it does not provide the heat itself. The heating element is located inside the IPS Disposable Unit. We note that the power drive unit is designed to fit into each adjacent part in its respective site.
2) The RapidSorb IPS Implant Cartridges will be manufactured in Switzerland and imported as part numbers 805.505.01S, 805.510.01S and 805.520.01S. They are imported in sterile packaging containing one sterilized unit each. The RapidSorb IPS Implant Cartridges contain resorbable copolymer. A cartridge is inserted into the RapidSorb IPS Delivery Device to load its polymer content into the device. Once the cartridge is empty it is removed from the Delivery Device and disposed of. When additional polymer is needed the Delivery Device can be loaded with the content from another full RapidSorb IPS Implant Cartridge. The RapidSorb IPS Implant Cartridges are provided sterile and are intended for single use only.
3) The RapidSorb IPS Delivery Device Starter Kit part number 805.550.01S consists of a RapidSorb IPS Implant Cartridge part number 805.500S and a RapidSorb IPS Delivery Device part number 530.552S. The RapidSorb IPS delivery device is a 2-part sterile shell. The Cartridge which contains polymer is loaded into the 2-part shell unit. Before operation, the drive unit and battery are inserted into the delivery device which then functions as the delivery system. The delivery device starter kit is a single use kit, which will be disposed of after the procedure. It is unclear from your submission if the battery pack and the support itself are included in the IPS Starter Kit.
The fastener lengths are pre-programmed and are selected by the user via the Fastener Size Control Knob located on the rear of the disposable portion of the device. This knob which controls the fastener length selection couples to a switch on the Power Drive Unit. When assembled, rotating the knob also rotates the switch on the Power Drive Unit. The switch controls the distance that the Power Drive Unit actuates the push rod. A surgeon will use the Synthes RapidSorb IPS system instead of screws or tacks. The system enables the fixation of support structures to bone through the creation of multiple fasteners of varying dimensions from the polymer of a single or multiple cartridges. The created fasteners are designed to be used with Synthes RapidSorb plates, meshes and sheets. In addition they may be used with RapidSorb meshes and sheets in non-load-bearing applications for maintaining the relative position of,
and/or containing, bony fragments, bone grafts, or bone graft substitutes in reconstruction of the craniofacial or mandibular areas. We note that the parts are all specifically designed and dedicated for use in the IPS.
The applicable subheading for the RapidSorb IPS Power Drive Unit - Synthes part number 530.551, will be 9018.90.7580, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Other: Electro-medical instruments and appliances used in medical, surgical or veterinary sciences and parts and accessories thereof.” The rate of duty will be free.
The applicable subheading for the RapidSorb IPS Implant Cartridges, Synthes part numbers 805.505.01S, 805.510.01S and 805.520.01S will be 9021.10.0090, Harmonized Tariff Schedule of the United States (HTSUS), which provides: Orthopedic or fracture appliances, and parts and accessories thereof: Other. The rate of duty will be free.
We do not have enough information to classify the RapidSorb IPS Delivery Device Starter Kit - Sterile - Synthes part number 805.550.01S. Please provide a clarification of exactly what is included in the starter kit in its condition as imported. Please also provide a sample of the complete starter kit if available if you decide to resubmit your request.
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 Paul Hodgkiss at (646) 733-3046 or at [email protected].
Sincerely,
Gwenn Klein Kirschner
Director
National Commodity Specialist Division