H353886

H353886 March 16, 2026 OT:RR:CTF:VSP H353886 SS CATEGORY: Classification TARIFF NO.: 9817.00.96 Mr. T. Min James III 1629 K Street NW, 300 Washington, DC 20006 RE: Applicability of Subheading 9817.00.96, HTSUS, to VADER Pedicle System and VADERone Pedicle System Dear Mr. James: This is in response to your request, on behalf of icotec AG, dated September 12, 2025, for a binding ruling regarding the eligibility of the VADER Pedicle System and VADERone Pedicle System for subheading 9817.00.96, Harmonized Tariff Schedule of the United States (“HTSUS”), treatment. Our ruling is set forth below. FACTS: icotec AG is an FDA-registered Swiss company that specializes in the development and distribution of spinal implant systems. The imported merchandise concerns icotec AG’s VADER Pedicle System and VADERone Pedicle System, (together the “VADER Systems”). The VADER Systems are implanted permanently into a patient’s spine to restore the integrity of their spinal columns. The VADER Systems function similarly except the VADER Pedicle System utilizes fenestrated screws to permit augmented fixation using bone cement injected into the vertebral body after screw placement while the VADERone Pedicle System lacks fenestrated screws and cannot be used with bone cement. The VADER Systems consist of polyaxial pedicle screws and rods, made of icotec AG’s proprietary BlackArmor® carbon-fiber reinforced polyetheretherketone (Carbon/PEEK) and/or titanium alloy. In addition to the screws and rods, connectors are made of BlackArmor® Carbon/PEEK, and cross-links and nut screws are made of titanium alloy. icotec AG states the VADER Systems work by stabilizing weakened or damaged segments of the spine in patients who have spinal tumors and infections by anchoring BlackArmor® Carbon/PEEK pedicle screws into the vertebrae, which are connected by rods. 1 icotec AG explains that the VADER Systems relieve pressure on the spinal cord and nerves, prevents further collapse or deformity, and enables patients to regain or preserve mobility and function. Without such intervention, icotec AG submits that those affected would be unable to perform basic life functions, such as standing, sitting upright, and walking, and would possibly be left entirely immobile. icotec AG states that the VADER Systems are used for patients with advanced stage cancerous tumors causing such instability of the spine that spinal fusion surgeries are not an option. Additionally, the VADER Systems are used for patients with severe spinal infections that impair spinal stability, such as spondylodiscitis and osteomyelitis. The VADER Systems include the following parts, which come in varying sizes to conform to a patient’s spinal structure: nuts, cross links, straight and curved rods, polyaxial screws, and axial and parallel connectors, which are composed of BlackArmor® Carbon/PEEK or titanium alloy. All parts for the VADER Systems are manufactured by icotec AG solely for use with the VADER Systems and must meet precise specifications and sterility requirements as articles to be implanted permanently in the human body. icotec AG states that there is no other use for the VADER Systems besides the uses noted above and the VADER Systems may only be ordered by a prescribing physician and installed by a surgeon. ISSUE: Whether the VADER Systems imported by icotec AG are eligible for duty-free treatment under subheading 9817.00.96, HTSUS. LAW AND ANALYSIS: The Nairobi Protocol to the Agreement on the Importation of Educational, Scientific and Cultural Materials of 1982, Pub. L. No. 97-446, 96 Stat. 2329, 2346 (1983) established the duty- free treatment for certain articles for the handicapped. Presidential Proclamation 5978 and Section 1121 of the Omnibus Trade and Competitiveness Act of 1988 provided for the implementation of the Nairobi Protocol into subheadings 9817.00.92, 9817.00.94, and 9817.00.96, HTSUS. 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.” In Sigvaris, Inc. v. United States, 227 F. Supp 3d 1327, 1336 (CIT 2017), aff’d, 899 F.3d 1308 (Fed. Cir. 2018), the U.S. Court of International Trade (“CIT”) explained that: The term “specially” is synonymous with “particularly,” which is defined as “to an extent greater than in other cases or towards others.” Webster’s Third New International Dictionary 1647, 2186 (unabr. 2002). The dictionary definition for “designed” is something that is “done, performed, or made with purpose and intent often despite an appearance of being accidental, 2 spontaneous, or natural.” Webster’s Third New International Dictionary 612 (unabr. 2002). Subheading 9817.00.96 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. Accordingly, eligibility within subheading 9817.00.96, HTSUS, depends on whether the article in question is “specially designed or adapted for the use or benefit of the blind or physically and mentally handicapped persons,” and whether it falls within any of the enumerated exclusions. See subheading 9817.00.96, HTSUS; U.S. Note 4(b), Subchapter XVII, Chapter 98, HTSUS. Note 4(a) to Chapter 98, HTSUS, provides: (a) For purposes of subheadings 9817.00.92, 9817.00.94 and 9817.00.96, 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. This list of exemplar activities indicates that the term “handicapped persons” is to be liberally construed so as to encompass a wide range of conditions, provided the condition substantially interferes with a person’s ability to perform an essential daily task. While the HTSUS and subchapter notes do not provide a proper definition of “substantial” limitation, the inclusion of the word “substantially” denotes that the limitation must be “considerable in amount” or “to a large degree.” CBP has recognized several factors to be utilized and weighed against each other on a case-by-case basis when determining whether a particular product is “specially designed or adapted” for the benefit or use of handicapped persons. See U.S. Customs Serv. Implementation of the Duty-Free Provisions of the Nairobi Protocol, Annex E, to the Florence Agreement, T.D. 92-77, 26 Cust. B. & Dec. 240, 241 (1992) (“Implementation of the Nairobi Protocol”) at 243- 244. These factors include: (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. See also Danze, Inc. v. United Stat

The Nairobi Protocol to the Agreement on the Importation of Educational, Scientific and Cultural Materials of 1982, Pub. L. No. 97-446, 96 Stat. 2329, 2346 (1983) established the duty- free treatment for certain articles for the handicapped. Presidential Proclamation 5978 and Section 1121 of the Omnibus Trade and Competitiveness Act of 1988 provided for the implementation of the Nairobi Protocol into subheadings 9817.00.92, 9817.00.94, and 9817.00.96, HTSUS. 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.” In Sigvaris, Inc. v. United States, 227 F. Supp 3d 1327, 1336 (CIT 2017), aff’d, 899 F.3d 1308 (Fed. Cir. 2018), the U.S. Court of International Trade (“CIT”) explained that: The term “specially” is synonymous with “particularly,” which is defined as “to an extent greater than in other cases or towards others.” Webster’s Third New International Dictionary 1647, 2186 (unabr. 2002). The dictionary definition for “designed” is something that is “done, performed, or made with purpose and intent often despite an appearance of being accidental, 2 

 spontaneous, or natural.” Webster’s Third New International Dictionary 612 (unabr. 2002). Subheading 9817.00.96 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. Accordingly, eligibility within subheading 9817.00.96, HTSUS, depends on whether the article in question is “specially designed or adapted for the use or benefit of the blind or physically and mentally handicapped persons,” and whether it falls within