The tariff classification of a spinal fixation system, a surgical instrument system, sterilization containers, a pedicle screw, and a nut breaker from France

N363252
August 3, 2026
CLA-2-90:OT:RR:NC:N3 135
CATEGORY: Classification
TARIFF NO.: 7326.90.8688; 9018.90.8000; 9021.10.0050; 9817.00.96
Shanshan Liang Liang + Mooney, PLLC 2104 Delta Way, Unit 1 Tallahassee, FL 32303 RE: The tariff classification of a spinal fixation system, a surgical instrument system, sterilization containers, a pedicle screw, and a nut breaker from France Dear Ms. Liang: In your letter dated July 10, 2026, on behalf of S.M.A.I.O SA, you requested a tariff classification ruling. Additional information was provided via email dated July 16, July 17, and July 20, 2026. The products under consideration are the KHEIRON® Spinal Fixation System, the KHEIRON® Surgical Instrument System, and the KHEIRON® Sterilization Containers. You state that the components of the KHEIRON® Spinal Fixation System and the KHEIRON® Surgical Instrument System may be imported separately and subsequently assembled into complete systems in the United States. However, a ruling letter normally addresses a specific set of facts. As requested, you have submitted a representative pedicle screw and a representative nut breaker for this ruling. The KHEIRON® Spinal Fixation System is a single modular spinal fixation platform used exclusively in reconstructive spinal surgery to restore spinal alignment and stabilize the thoracic, lumbar, sacral, and pelvic regions of the spine in patients suffering from severe spinal deformities and chronic spinal instability. The overwhelming majority of patients receiving the KHEIRON® System suffer from permanent or chronic spinal impairments. These conditions include, among others, adult degenerative scoliosis, adolescent idiopathic scoliosis, congenital scoliosis, neuromuscular scoliosis, hyper-kyphosis, pathological lordosis, sagittal imbalance, degenerative disc disease, degenerative spondylolisthesis, spinal stenosis, pseudarthrosis, adjacent segment disease, failed spinal fusion, chronic spinal instability, and spinal deformities associated with tumors or other structural disorders. You explain that these disorders are not temporary orthopedic injuries. Rather, they are chronic, frequently progressive conditions that cause structural abnormalities of the spine, neurological compromise, chronic pain, reduced mobility, impaired balance, abnormal posture, diminished pulmonary function in severe deformity cases, and substantial limitations in walking, standing, lifting, bending, working, and other major

life activities. The purpose of the KHEIRON® Spinal Fixation System is to compensate for these chronic structural impairments by restoring spinal alignment, providing long-term internal stabilization, and maintaining correction following spinal arthrodesis. The KHEIRON® Spinal Fixation System comprises multiple families of compatible fixation components that are selected and assembled by the surgeon according to the patient's anatomy and the clinical requirements of the particular spinal reconstruction. The components include monoaxial pedicle screws with nuts and rod connectors, titanium rods (straight, pre-bent, and patient-specific K-rods), sacral plates and connectors, iliac extensions with dedicated iliac screws and locking mechanisms, hooks and claws for thoracic anchorage, and rod-to-rod “domino” and transverse connectors. You explain that the various bone anchorage options—including pedicle screws, sacral plates, iliac fixation components, hooks, and other fixation elements—are alternative anchoring components within the same integrated spinal fixation system and are designed to function together with the common rod-and-connector architecture of the KHEIRON® modular spinal fixation platform. The fundamental structural principle of the KHEIRON® Spinal Fixation System is consistent regardless of which bone anchorage is selected. The system consists of: (1) one or more bone anchorage devices that are secured to the patient's skeletal anatomy, (2) longitudinal titanium rods that provide the principal structural support, (3) dedicated connectors that join the bone anchorages to the rods, and (4) specialized locking nuts that rigidly secure the completed construct. For example, when pedicle fixation is utilized, a monoaxial pedicle screw is implanted into the pedicle of the vertebra. The pedicle screw is connected to the longitudinal rod by means of the corresponding pedicle screw connector, and the connection is secured using the dedicated pedicle screw locking nut. Alternatively, when sacral fixation is required, the KHEIRON® System utilizes a sacral plate as the bone anchorage. The sacral plate is secured to the sacrum using two dedicated sacral screws. The sacral plate is then connected to the longitudinal rod through the corresponding sacral connector, and the assembly is secured using the dedicated sacral locking nut. The KHEIRON® Surgical Instrument System consists of reusable surgical instruments specially designed and engineered exclusively for implantation of the KHEIRON® Spinal Fixation System. These instruments include proprietary pedicle probes, rod templates, screwdrivers, torque instruments, reduction devices, rod holders, connector holders, nut breakers, taps, and other surgical instruments that interface directly with the unique geometry of the KHEIRON® implants and have no practical use with unrelated spinal fixation systems. Many of these instruments are dimensioned specifically for the system's 5.5 mm and 6.0 mm implant architecture and incorporate features required to engage the system's proprietary breakaway locking mechanism. You claim that the surgical instruments are essential for the installation of the KHEIRON® Spinal Fixation System. Unlike generic orthopedic instruments, these tools are engineered solely for implantation of the KHEIRON® System and cannot perform their intended functions with unrelated spinal fixation systems. You explain that the complete reusable surgical instrument system marketed in the United States consists of five dedicated instrument trays, together with their corresponding lids and implant caddies. Collectively, these trays contain the complete set of proprietary surgical instruments required for implantation of the KHEIRON® Spinal Fixation System. Each tray contains a different group of instruments organized according to their surgical function. For example, one tray contains the instruments used for pedicle screw implantation, while other trays contain specialized instruments for rod preparation, connector placement, sacral fixation, iliac fixation, reduction maneuvers, and final assembly of the spinal construct. All five trays collectively comprise the complete KHEIRON® Surgical Instrument System. The representative KHEIRON® Pedicle Screw is an implant-grade titanium monoaxial pedicle screw specially designed as an integral component of the KHEIRON® Spinal Fixation System. It is available in multiple diameters and lengths to accommodate patient anatomy and surgical requirements. The pedicle screw incorporates proprietary dimensions, thread geometry, tulip head configuration, and locking interfaces engineered specifically for the KHEIRON® platform. It is intended solely for implantation into the thoracic,

lumbar, or sacral spine by trained spinal surgeons and has no practical application outside reconstructive spinal surgery. During surgery, the screw is inserted into the pedicle of a vertebra and serves as the primary anchoring point of the spinal fixation construct. The pedicle screw interfaces exclusively with the KHEIRON® rod, connector, locking nut, and dedicated instrumentation to secure each vertebral level to the longitudinal fixation rod, allowing progressive reduction, derotation, stabilization, and maintenance of spinal alignment throughout the fusion process. The representative KHEIRON® Nut Breaker is a reusable surgical instrument specially designed for implantation of the KHEIRON® Spinal Fixation System by engaging its proprietary break-off locking mechanism. It is specifically dimensioned to engage the KHEIRON® implant architecture and cannot perform its intended function on unrelated spinal fixation systems. During implantation, the KHEIRON® locking nuts are tightened to a predetermined torque. After final tightening, the protruding break-off portion of the locking mechanism is intentionally removed using the Nut Breaker, thereby leaving a low-profile final construct while simultaneously confirming that the specified locking torque has been achieved. The instrument is supplied exclusively through professional medical channels and is used only by trained spinal surgeons during implantation of the KHEIRON® Spinal Fixation System. The KHEIRON® Sterilization Containers consist of stainless-steel instrument trays with matching stainless-steel lids, together with molded polymer implant caddies and transparent lids designed specifically to organize, protect, transport, sterilize, and present KHEIRON® implants and surgical instruments during spinal surgery. The plastic caddies fit securely within the metallic trays, creating an integrated modular container system specifically configured for the KHEIRON® platform. Unlike generic sterilization trays used throughout hospitals, the KHEIRON® containers incorporate dedicated recesses, racks, holders, and molded compartments designed to retain specific KHEIRON® pedicle screws, sacral plates, connectors, surgical instruments, and associated items. The internal configuration corresponds precisely to the dimensions and arrangement of KHEIRON® implants and surgical instruments, allowing the articles to remain securely positioned throughout sterilization, storage, transportation, and surgical preparation. The containers are intended exclusively for repeated use with the KHEIRON® Spinal Fixation System and have no meaningful commercial application apart from that system. The applicable subheading for the KHEIRON® Sterilization Containers will be 7326.90.8688, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Other articles of iron or steel: Other: Other: Other: Other: Other.” The general rate of duty will be 2.9 percent ad valorem. The applicable subheading for the KHEIRON® Surgical Instrument System, as well as for the KHEIRON® Nut Breaker when imported separately, will be 9018.90.8000, HTSUS, which provides for “other” instruments and appliances and parts and accessories thereof used in the medical, surgical, dental or veterinary sciences. The general rate of duty will be free. The applicable subheading for the KHEIRON® Spinal Fixation System, as well as for the KHEIRON® Pedicle Screw when imported separately, will be 9021.10.0050, 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. In New York Ruling (NY) N362665, dated July 15, 2026, CBP extended the same duty-free treatment to pedicle screws and locking set screws used in spinal fixation systems. In NY 898450, dated June 24, 1994, CBP found that surgical instruments dedicated for used in hip replacement operations qualified for duty-free treatment under subheading 9817.00.96, HTSUS. CBP has consistently determined that spinal fixation systems and their specially designed components used in spinal fusion procedures for patients with chronic spinal impairments qualify for duty-free treatment under subheading 9817.00.96, HTSUS. The subject KHEIRON® Spinal Fixation System is specially designed for the surgical correction of severe spinal deformities and chronic spinal instability in patients with permanent or chronic musculoskeletal impairments that substantially limit major life activities, such as walking and working. The KHEIRON® Pedicle Screw is a principal implant component of this system. The KHEIRON® Surgical Instrument System is designed exclusively for the implantation of the KHEIRON®

Spinal Fixation System, while the KHEIRON® Nut Breaker is a specialized surgical instrument required for proper implantation. The KHEIRON® Sterilization Containers are designed exclusively to organize, sterilize, transport, store, and present KHEIRON® implants and surgical instruments during spinal surgery. Based on the information provided and the cited precedent rulings, the KHEIRON® Spinal Fixation System, KHEIRON® Surgical Instrument System, KHEIRON® Pedicle Screw when imported separately, KHEIRON® Nut Breaker when imported separately, and KHEIRON® Sterilization Containers are all 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 (NIS ) Matthew Gay at [email protected] for the KHEIRON® S terilization Containers, NIS Dionisia Y. Melman at [email protected] for the KHEIRON® Surgical Instrument System and the KHEIRON® Nut Breaker, or NIS Fei Chen at [email protected] for the KHEIRON® Spinal Fixation System and the KHEIRON® Pedicle Screw.
Sincerely,
(for) James P. Forkan Director National Commodity Specialist Division