Applicability of Subheading 9817.00.96, HTSUS to CMORE CT System

H353889 March 16, 2026 OT:RR:CTF:VSP H353889 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 CMORE CT 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 CMORE CT 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 CMORE CT (cervico-thoracic) System. The CMORE CT System is permanently implanted into patients by surgeons to provide posterior stabilization of the upper spine. The CMORE CT system consists of polyaxial solid screws made of icotec AG’s proprietary BlackArmor® carbon-fiber reinforced polyetheretherketone (Carbon/PEEK) material, with embedded tantalum markers in the tip and head of each screw. The screws are embedded in the upper spine and linked with connectors to rods, both of which are composed of BlackArmor® Carbon/PEEK. Once assembled, the CMORE CT System creates an internal framework that immobilizes and stabilizes the cervical and upper thoracic spine. icotec AG maintains that without such surgical stabilization, those affected face risks such as losing the ability to stand, walk, or sit upright. Additionally, they may face permanent neurological damage, spinal deformity, and life- threatening complications from sepsis or respiratory failure from a collapsed spinal structure. icotec AG submits that the CMORE CT System is used for patients with the following 1 medical conditions: (1) advanced stage tumors involving the cervical spine in whom life expectancy prior to treatment is of insufficient duration to permit spinal fusion; (2) traumatic spinal fractures and/or dislocations; (3) spinal instability or deformity; (4) failed previous fusions (e.g., pseudoarthrosis); (5) degenerative disease, including intractable radiculopathy and/or myelopathy; (6) neck and/or arm pain of discogenic origin as confirmed by radiographic studies; (7) degenerative disease of the facets with instability; and (8) patients with spinal infections (e.g., spondylodiscitis, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression. icotec AG states that the CMORE CT System is designed to restore patients’ spinal stability who suffer from these conditions. The CMORE CT System includes the following parts, which come in varying sizes to conform to a patient’s spine: nuts and nut screws, cross links, straight and curved rods, polyaxial and shank screws, and axial and parallel connectors, which are composed of BlackArmor® Carbon/PEEK or titanium alloy. All parts for the CMORE CT System are manufactured by icotec AG solely for use with the CMORE CT System 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 CMORE CT System besides the uses noted above and the CMORE CT System may only be ordered by a prescribing physician and installed by a surgeon. ISSUE: Whether the CMORE CT System imported by icotec AG is 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, spontaneous, or natural.” Webster’s Third New International Dictionary 612 (unabr. 2002). 2 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 States, Slip Op. 18-69 (Ct. Int’l Trade 2018); Sigvaris, Inc. v. United States, 227 F.Supp.3d 1327 (Ct. Int’l Trade, 2017), aff’d, 899 F.3d 1308 (Fed. Cir. 2018). The court in Sigvaris, 899 F.3d. 1308 (Fed. Cir. 2018), found that “[t]hese factors aid in assessing whether the subject merchandise is intended for the use or benefit of a specific class of persons to a greater extent than for the use or benefit of others.” The court adopted these factors into its analysis. 3 Analysis of the five Sigvaris factors shows that that the CMORE CT System is specifically designed for the use of the handicapped. First, the CMORE CT System is made of polyaxial solid screws made of icotec AG’s proprietary BlackArmor® carbon-fiber reinforced polyetheretherketone (Carbon/PEEK) material, with embedded tantalum markers in the tip and head of each screw, which are then embedded in the spine and connected with rods. Because of the special material used, we find the CMORE CT System possesses design features that distinguish them from ordinary screws and rods. Second, given the fact that the CMORE CT System must be surgically implanted by a surgeon into a patient’s spine, it is improbable that an individual would seek out the CMORE CT System unless they had physical disabilities, such as spinal instability, that necessitated its use. Third, the importer has identified themselves as an FDA-registered Swiss company that specializes in the development and distribution of spinal implant systems. Fourth, the CMORE CT System can only be ordered by a prescribing physical and then installed by a surgeon. Fifth, the submitted samples have specialized features that suggest the articles are suitable for the handicapped. This ruling is similar to previous rulings in which CBP has considered whether various spinal implant devices are for the use of the handicapped. In New York Ruling Letter (NY) N201418, dated February 17, 2012, CBP agreed with a secondary classification of Medtronic’s Capstone Peek Spinal Fusion System, which was composed of pieces such as tantalum pins, as well as other spinal fusion systems and pedicle screw systems, as articles specially designed or adapted for the use or benefit of the handicapped in subheading 9817.00.96, HTSUS. In addition, Headquarters Ruling Letter (HQ) H313200, dated November 9, 2020, CBP held that tantalum pins used by surgeons to install spinal implant systems were essential components and thus, were eligible for duty-free treatment under subheading 9817.00.96, HTSUS, as a part of an article specially designed or adapted for the use or benefit of the handicapped. We have no reason to question the decision in either ruling and we find the CMORE CT System is similar to the spinal fusion systems and pedicle screw systems that were integrated into patient’s compromised spines to help with spinal stabilization and movement. Subheading 9817.00.96, HTSUS, also excludes therapeutic and diagnostic articles. In Richards Medical Co. v. U.S., 13 C.I.T. 519 (1989), “the Court {found} that the term ‘therapeutic’ distinguishes articles, which are used to heal the condition causing a handicap, from those duty-free articles which are designed to compensate for, or adapt to, the handicapped condition.” The court determined that a prosthetic hip was not a therapeutic article. Further, in Travenol Lab. V. U.S., 17 C.I.T. 69 (1993), the court determined that, because kidney dialysis does not restore the kidney function of a person with renal failure, it was not a therapeutic procedure. Like prosthetic hip and dialysis articles, the CMORE CT System, helps manage but does not cure an underlying condition. Like the prosthetic hip, these systems simply help manage spinal conditions. Therefore, the CMORE CT System is eligible for duty-free treatment under subheading 9817.00.96, HTSUS. HOLDING: The CMORE CT System at issue is 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. 4 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 the internet at https://hts.usitc.gov. Please note that 19 C.F.R. § 177.9(b)(1) provides that “[e]ach ruling letter is issued on the assumption that all of the information furnished in connection with the ruling request and incorporated in the ruling letter, either directly, by reference, or by implication, is accurate and complete in every material respect. The application of a ruling letter by a Customs Service field office to the transaction to which it is purported to relate is subject to the verification of the facts incorporated in the ruling letter, a comparison of the transaction described therein to the actual transaction, and the satisfaction of any conditions on which the ruling was based.” A copy of this ruling letter should be attached to the entry documents filed at the time the goods are entered. If the documents have been filed without a copy, this ruling should be brought to the attention of the CBP officer handling the transaction. Sincerely, Monika R. Brenner, Chief Valuation and Special Programs Branch 5