The tariff classification of pedicle screw systems from Switzerland

N362426 July 15, 2026 CLA-2-90:OT:RR:NC:N3 135 CATEGORY: Classification TARIFF NO.: 9021.10.0050; 9817.00.96 Samuel Finkelstein LMD Trade Law PLLC 1629 K Street NW Washington, DC 20006 RE: The tariff classification of pedicle screw systems from Switzerland Dear Mr. Finkelstein: In your letter dated June 18, 2026, on behalf of Hythe Holdings, Inc., dba Astura Medical, you requested a tariff classification ruling. The products under consideration are the MASADA Modular Spinal Fixation System, MASADA Minimally Invasive Spinal Fixation System, MASADA Sacral-Alar-Iliac Screw System, OLYMPIC Posterior Spinal Fixation System, and OLYMPIC Minimally Invasive Spinal Fixation System. The MASADA Modular Spinal Fixation System (referred to as “Masada”) is a pedicle screw system comprised of pedicle and iliac screws (available in various lengths and diameters), connecting rods (in multiple lengths), and iliac, axial, and parallel connectors. All components are manufactured exclusively for use with the Masada System and must adhere to strict specifications and sterility requirements for implantation in the human body. The system is specially designed for patients with spinal conditions involving mechanical instability or deformity, such as degenerative disc disease (DDD), spondylolisthesis, spinal trauma, spinal stenosis, spinal curvatures (e.g., scoliosis, kyphosis, lordosis), spinal tumors, and failed prior spinal fusion procedures. The system is intended for posterior immobilization and stabilization of damaged, non-cervical spinal segments as an adjunct to spinal fusion. The MASADA Minimally Invasive Spinal Fixation System (“Masada MIS”) is an adapted version of the Masada System for minimally invasive surgical procedures. It consists of surgical screws, rods, and connectors in various sizes to accommodate patient morphology and surgical technique. All components are manufactured solely for use with Masada MIS and must meet the same rigorous specifications and sterility requirements. Masada MIS treats the same spinal conditions as the Masada System but offers greater intraoperative flexibility for a wider range of surgical techniques. The MASADA Sacral-Alar-Iliac Screw System (“Masada S2AI”) expands the Masada System to provide joint fixation and fusion between the S1 and S2 neuroforamina, offering an innovative approach to sacropelvic fixation for patients with sacral spine and pelvic impairments. It consists of cannulated and fenestrated screws that are compatible with the Masada System, specifically designed for pelvic insertion. All components are manufactured exclusively for Masada S2AI and must meet precise specifications and sterility requirements. The OLYMPIC Posterior Spinal Fixation System (“Olympic”) is a pedicle screw system comprising polyaxial and monoaxial screws (in various lengths and diameters), connecting rods (in multiple lengths), cross connectors, and hooks. All components are manufactured solely for use with the Olympic System and must meet strict specifications and sterility requirements for implantation. The system is intended for patients with spinal conditions involving mechanical instability or deformity, including DDD, spondylolisthesis, spinal trauma, spinal stenosis, spinal curvatures, spinal tumors, and failed prior spinal fusion. Olympic provides posterior immobilization and stabilization of non-cervical spinal segments as an adjunct to spinal fusion. The OLYMPIC Minimally Invasive Spinal Fixation System (“Olympic MIS”) is an adapted version of the Olympic System for minimally invasive procedures. It includes surgical screws, rods, and connectors in various sizes to accommodate patient morphology and surgical technique. All components are manufactured exclusively for Olympic MIS and must meet stringent specifications and sterility requirements. Olympic MIS is intended for the same patient population and conditions as the Olympic System. The applicable subheading for the MASADA Modular Spinal Fixation System, MASADA Minimally Invasive Spinal Fixation System, MASADA Sacral-Alar-Iliac Screw System, OLYMPIC Posterior Spinal Fixation System, and OLYMPIC Minimally Invasive Spinal Fixation System 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, U.S. 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 HQ H353889, dated March 16, 2026, CBP ruled that the CMORE CT system was eligible for duty-free treatment under subheading 9817.00.96, HTSUS. The CMORE CT system consists of polyaxial screws, rods, connectors, nut screws, and other components. It is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion. CBP has determined that pedicle screw systems (spinal fixation systems) used in spinal fusion procedures for patients with chronic spinal impairments qualify for duty-free treatment under subheading 9817.00.96, HTSUS. The subject pedicle screw systems are specially designed and medically indicated for spinal stabilization as an adjunct to spinal fusion in patients with chronic spinal impairments that substantially limit major life activities. Based on the information provided and precedent rulings, these systems are also 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 fei.chen@cbp.dhs.gov. Sincerely, (for) James P. Forkan Director National Commodity Specialist Division