The tariff classification of CORUS Implants and CORUS Surgical Systems from Costa Rica

N362091
June 30, 2026
CLA-2-90:OT:RR:NC:N3 135
CATEGORY: Classification
TARIFF NO.: 9021.10.0050; 9817.00.96
David Townsend Dorsey & Whitney 50 South 6th Street, Suite 1500 Minneapolis, MN 55402 RE: The tariff classification of CORUS Implants and CORUS Surgical Systems from Costa Rica Dear Mr. Townsend: In your letter dated June 4, 2026, on behalf of Providence Medical Technology, Inc., you requested a tariff classification ruling. Additional information was provided via email dated June 18 and June 22, 2026. The classification of the CORUS Navigation Access System will be addressed in a separate correspondence. The products under consideration are the CORUS Implants (CORUS PCSS Implant and CORUS-LX Implant) and the CORUS Surgical Systems (CORUS Spinal System-LX and CORUS PCSS LevelOne). The CORUS Implant is an integrated screw fixation system consisting of a small cage-like device and two fixation screws. It is available in various dimensions to accommodate patient-specific cervical or lumbar bone and joint anatomy. The CORUS PCSS Implant is the cervical version of the CORUS Implant, while the CORUS LX is the lumbar version. The CORUS PCSS Implant and the CORUS LX Implant are essentially the same product, differing only in size and intended joint location. The implant is not intended to replace the spinal disc; rather, it is designed for placement across the cervical or lumbar facet joints. Implanted bilaterally, the device immobilizes and stabilizes spinal segments by spanning the interspace with fixation points at each end. It acts as a stabilization system and provides a reservoir for bone graft material. The CORUS Implant must be used with an intervertebral body fusion device at the same spinal level(s) and may also be used with a pedicle screw and rod system at the same level(s). The implant is made of implant-grade titanium alloy (6AI-4V titanium), sterilized prior to importation, and manufactured to precise dimensions to ensure proper function and promote joint fusion. The CORUS Implant has no intended or known use outside of implantation. In the imported condition, the cage-like device is pre-loaded onto a disposable delivery instrument. Each fixation screw is housed within a protective plastic tubing. All components are packaged in a blister pack within a paper box for retail sale. Once the delivery instrument and cage-like device are positioned between the joints, the bone screw(s) slide down the delivery instrument to guide and assist with screw placement within the cage-like device. The surgeon twists the screws until they are fully inserted and locked into the cage-like device. Afterward, the delivery instrument and protective plastic tubing are disposed of.

The CORUS Surgical System is imported as a surgical kit. It contains two CORUS Implants, each pre-loaded onto a disposable delivery instrument, along with a complete set of single-use, disposable, sterilized instruments. They include access chisel with detachable handle, trephine decorticator, guide tube, rasp decorticator, rotary decorticator, bone graft tamp, multi-tool, and divine. These instruments are necessary for joint access, bone preparation, implant delivery, and bone graft application. All components are arranged in two trays and packaged in a blister pack within a paper retail box for sale to hospitals. The top tray contains instruments for preparing the patient’s spine, while the second tray includes the two CORUS Implants and tools for implant placement. The surgical kit is intended solely to facilitate placement of the CORUS Implants and is disposed of after single-patient use. The CORUS Spinal System-LX is the lumbar version of the CORUS Surgical System, while the CORUS PCSS LevelOne is the cervical version. You claim that the CORUS Implant is designed to promote cervical and lumbar fusion in patients experiencing degenerative disk disease (DDD). DDD is the gradual breakdown of spinal discs, which can cause chronic pain, stiffness, and limited movement, substantially limiting patients from performing manual tasks, walking, or participating in everyday life. The CORUS Implant helps the most high-risk DDD patients who have had a low rate of success when receiving traditional standards of care. U.S. Customs and Border Protection (CBP) has historically classified prefilled medical devices based on their contents, and medical implants and devices packaged for retail sale are typically classified under General Rule of Interpretation (GRI) 3. Kits containing a medical implant and tools for administration are generally classified based on the essential character of the implant. The applicable subheading for the CORUS Implants and CORUS Surgical Systems will be 9021.10.0050, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Orthopedic or fracture appliances, and parts and accessories thereof: Bone plates, screws and nails, and other internal fixation devices or appliances.” The general rate of duty will be free. In your submission you requested consideration of a secondary classification under 9817.00.96, HTSUS, which applies to articles and parts of articles specifically designed or adapted for the use or benefit of the permanently or chronically physically or mentally handicapped. Subheading 9817.00.96, HTSUS, covers: “Articles specially designed or adapted for the use or benefit of the blind or other physically or mentally handicapped persons; parts and accessories (except parts and accessories of braces and artificial limb prosthetics) that are specially designed or adapted for use in the foregoing articles . . . Other.” The term “blind or other physically or mentally handicapped persons” includes “any person suffering from a permanent or chronic physical or mental impairment which substantially limits one or more major life activities, such as caring for one’s self, performing manual tasks, walking, seeing, hearing, speaking, breathing, learning, or working.” U.S. Note 4(a), Subchapter XVII, Chapter 98, HTSUS. Subheading 9817.00.96, HTSUS, excludes “(i) articles for acute or transient disability; (ii) spectacles, dentures, and cosmetic articles for individuals not substantially disabled; (iii) therapeutic and diagnostic articles; or, (iv) medicine or drugs.” U.S. Note 4(b), Subchapter XVII, Chapter 98, HTSUS. In Sigvaris, Inc. v. United States, 227 F. Supp 3d 1327, 1336 (Ct. Int’l Trade 2017), aff’d, 899 F.3d 1308 (Fed. Cir. 2018), the U.S. Court of International Trade (CIT) explained that “specially” means “to an extent greater than in other cases or towards others” and “designed” means something that is “done, performed, or made with purpose and intent often despite an appearance of being accidental, spontaneous, or natural.” We must first evaluate “for whose, if anyone’s, use and benefit is the article specially designed,” and then, whether “those persons [are] physically handicapped [].” Sigvaris, 899 F.3d at 1314.

The Court of Appeals for the Federal Circuit (CAFC) clarified in Sigvaris, 899 F.3d at 1314-15 that to be “specially designed,” the merchandise “must be intended for the use or benefit of a specific class of persons to an extent greater than for the use or benefit of others” and adopted the five factors used by U.S. Customs and Border Protection (CBP): (1) the physical properties of the article itself (i.e., whether the article is easily distinguishable by properties of the design, form, and the corresponding use specific to this unique design, from articles useful to non-handicapped persons); (2) whether any characteristics are present that create a substantial probability of use by the chronically handicapped so that the article is easily distinguishable from articles useful to the general public and any use thereof by the general public is so improbable that it would be fugitive; (3) whether articles are imported by manufacturers or distributors recognized or proven to be involved in this class or kind of articles for the handicapped; (4) whether the articles are sold in specialty stores which serve handicapped individuals; and, (5) whether the condition of the articles at the time of importation indicates that these articles are for the handicapped. In Headquarters Ruling Letter (HQ) H359802, dated May 26, 2026, Customs and Border Protection (CBP) determined that an expandable lumbar fusion cage intended for use in patients with degenerative disc disease at one or two contiguous levels of the lumbosacral spine (L2–S1) qualified for duty-free treatment under subheading 9817.00.96, HTSUS. In HQ H353886, dated September 12, 2025, CBP held that the VADER Pedicle System and VADERone Pedicle System, which are permanently implanted to restore spinal column integrity, were also eligible for duty-free treatment under subheading 9817.00.96, HTSUS. The VADER Systems are used for patients with advanced-stage cancerous tumors causing spinal instability where spinal fusion is not an option, as well as for patients with severe spinal infections such as spondylodiscitis and osteomyelitis. In this case, the CORUS Implant is designed for implantation in the facet joint and intended to provide stabilization as an adjunct to an interbody fusion procedure. It must be used in conjunction with an intervertebral body fusion device implanted at the same spinal level(s). The CORUS Implant is indicated for the treatment of patients with degenerative disc disease who have failed conservative treatment. The CORUS Surgical System includes the CORUS Implant and the instruments required to facilitate joint access, bone preparation, implant delivery, and bone graft application for the implant. The physical dimensions of each item are carefully constructed for their specific performance as tools to facilitate the surgeon’s preparation and placement of the CORUS Implant. Based on the information provided, the CORUS Implants and CORUS Surgical Systems are eligible for duty-free treatment under subheading 9817.00.96, HTSUS, as articles specially designed or adapted for the use or benefit of the blind or other physically or mentally handicapped persons. The duties cited above are current as of this ruling’s issuance. 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 at https://hts.usitc.gov/. This ruling does not address the applicability of any additional duties, taxes, fees, exactions and/or other charges, which may apply to the goods discussed herein. This includes, but is not limited to, tariffs and other duties as provided for in Subchapter III to Chapter 99, HTSUS. Thus, for example, in addition to the classification stated above, the merchandise covered by this ruling may also need to be reported with either the Chapter 99 provision under which an additional tariff applies or one of the Chapter 99 provisions covering exceptions to such tariffs. For further information to assist with the importation process, please refer to the frequently updated Cargo Systems Messaging Service (CSMS) messages at https://www.cbp.gov/trade/automated/cargo-systems-messaging-service and the Trade Remedies page at https://www.cbp.gov/trade/programs-administration/trade-remedies.

The holding set forth above applies only to the specific factual situation and merchandise description as identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations (CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and complete in every material respect. In the event that the facts are modified in any way, or if the goods do not conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2. Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic verification by CBP. This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection 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, please contact National Import Specialist Fei Chen at [email protected].
Sincerely,
(for) James P. Forkan Director National Commodity Specialist Division