Applicability of Subheading 9817.00.96, HTSUS to Expandable Lumbar Fusion Cage

H359802 May 26, 2026 OT:RR:CTF:VSP H359802 ACH CATEGORY: Classification TARIFF NO: 9817.00.96 Mr. Brandon Walton Captiva Spine, Inc. 967 N. Alternate A1A Jupiter, FL 33477 RE: Applicability of Subheading 9817.00.96, HTSUS to Expandable Lumbar Fusion Cage Dear Mr. Walton, This is in response to your request, on behalf of Captiva Spine, Inc. (“Captiva”), dated March 20, 2026, for a binding ruling regarding the eligibility of the Expandable Lumbar Fusion Cage for subheading 9817.00.96, Harmonized Tariff Schedule of the United States (“HTSUS”), treatment.1 Our ruling is set forth below. FACTS: The merchandise under consideration is an expandable lumbar cage composed of titanium alloy. It is an expandable interbody fusion device available in various lengths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to provide support and correction during and after lumbar interbody fusion surgeries. It is intended for stabilization and to promote bone fusion during the normal healing process following surgical correction of spinal disorders. Specifically, the interbody fusion device is intended for use in patients with degenerative disc disease (“DDD”) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is a form of arthritis in which the cartilage in the spine joints begins to wear down.2 The degeneration of the disc is confirmed by history and by radiographic studies. Patients with DDD may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. Patients having the cage implanted should be skeletally mature and will have 1 Captiva also requested CBP address the underlying classification of the Expandable Lumbar Fusion Cage. Classification will be addressed in a separate response. 2 https://www.hopkinsmedicine.org/health/conditions-and-diseases/degenerative-disc-disease 2 undergone at least six months of non-operative treatment before the Fusion Cage is implanted. The device is implanted during spinal fusion surgery and remains in the body long-term. It is used in conjunction with bone graft material and supplemental fixation systems, such as a posterior spinal fixation system. Captiva states that the device is permanently implanted and specifically designed for use in spinal fusion procedures to treat chronic degenerative conditions of the spine, that it is not a general-use surgical instrument or device, and that the device is not used for temporary trauma fixation or general surgical purposes. It is used exclusively by trained orthopedic or neurosurgeons in spinal procedures. ISSUE: Whether the Expandable Lumbar Fusion Cage imported by Captiva is eligible for duty-free treatment under subheading 9817.00.96, HTSUS. LAW AND ANALYSIS: Eligibility for Duty-Free Treatment under Subheading 9817.00.96, HTSUS. 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). 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 3 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.” In this case, DDD is a form of arthritis, which CBP has previously ruled is an impairment which substantially limits one or more major life activities.3 See Headquarters Ruling Letter (“HQ”) H960967, dated November 8, 1991; HQ 556090, dated November 8, 1991; H346874, dated May 16, 2025; and H318562, dated July 20, 2022. 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. Analysis of the five Sigvaris factors shows that that the Fusion Cage is specifically designed for the use of the handicapped. First, because the physical properties of the cage would 3 https://www.hopkinsmedicine.org/health/conditions-and-diseases/degenerative-disc-disease 4 not make it beneficial for those who do not have a spinal disorder, we find the Fusion Cage possesses design features that distinguish it from articles used for purposes other than for the correction of spinal disorders. Second, because the Fusion Cage is only used after those with DDD have undergone at least six months of failed conservative and non-operative treatment, it will not be used by the general public. Third, the importer is a company that “delivers spine navigation, spinal implant systems, and procedural solutions built for real-world adoption.”4 Fourth, the Fusion System can only be installed by orthopedic surgeons or neurosurgeons. Fifth, the provided images show the articles 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, in 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. Further, in HQ H353889, dated March 16, 2026, CBP determined that a system of implanted screws designed to provide posterior stabilization of the upper spine were eligible for duty-free treatment under subheading 9817.00.96, HTSUS. We have no reason to question the decision in these rulings and find that the Fusion Cage is similar to the spinal fusion and screw systems that are 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 the prosthetic hip and dialysis articles, the Fusion Cage helps manage but does not cure an underlying condition. Like the prosthetic hip, these systems simply help manage spinal conditions. Therefore, the Fusion Cage is eligible for duty-free treatment under subheading 9817.00.96, HTSUS. HOLDING: The Expandable Lumbar Fusion Cage 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. Duty rates are provided for your convenience and are subject to change. The text of the 4 https://www.captivaspine.com/ 5 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