The tariff classification of Polyaxial Pedicle Screws, MIS Extended-Tab Pedicle Screws, and Locking Set Screws from Taiwan

N362665 July 15, 2026 CLA-2-90:OT:RR:NC:N3 135 CATEGORY: Classification TARIFF NO.: 9021.10.0050; 9817.00.96 Brandon Walton Captiva Spine, Inc. 967 N Alternate A1A, Suite 1 Jupiter, FL 33477 RE: The tariff classification of Polyaxial Pedicle Screws, MIS Extended-Tab Pedicle Screws, and Locking Set Screws from Taiwan Dear Mr. Walton: In your letter dated June 26, 2026, you requested a tariff classification ruling. The products under consideration are CapLOX II® Polyaxial Pedicle Screws, TowerLOX® Polyaxial Pedicle Screws, MIS Extended-Tab Pedicle Screws (TowerLOX-EXT®), CapLOX II® Locking Set Screws, and TowerLOX® Locking Set Screws. These screws are components of the CapLOX II® Pedicle Screw System or the TowerLOX® MIS Pedicle Screw System, which are titanium alloy spinal fixation systems consisting of screws, set screws, rods, and cross connectors for use in the thoracic, lumbar, and sacral spine. The CapLOX II® Pedicle Screw System is configured exclusively for traditional open posterior surgical approaches, while the TowerLOX® MIS Pedicle Screw System is specifically optimized for minimally invasive surgery (MIS) or “mini-open” techniques. These systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine, including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis, and failed previous fusion. The Polyaxial Pedicle Screw is described as a multi-component bone-anchoring implant consisting of a continuous, dual-lead threaded bone shaft and a multi-directional (polyaxial) open housing head (tulip). It is manufactured from high-strength titanium alloy (Ti-6Al-4V ELI per ASTM F136). The polyaxial mechanism allows the housing head to articulate up to 63° relative to the longitudinal axis of the bone screw, minimizing the need for aggressive, complex manual contouring of the longitudinal support rod during multi-segment constructs. The screw is designed to be rigidly anchored into the vertebral bodies of the thoracolumbosacral spine to provide stability and facilitate multisegmental spinal fusion. It is permanently implanted during spinal surgery, remains in the body long-term, and is used in conjunction with interconnecting rods and locking set screws. Each MIS Extended-Tab Pedicle Screw shares the exact same internal structural dimensions, dual-lead bone threads, and polyaxial head interface as the standard Polyaxial Pedicle Screw. However, it features two parallel, rigid metallic extension walls (extended tabs) projecting proximally from the upper edges of the tulip head. These tabs extend up through the patient's skin layer during MIS procedures to direct rod insertion and are snapped off cleanly at a pre-machined internal score line once assembly is complete. The screw portion is permanently implanted during spinal surgery and remains in the body long-term, after which the delivery tabs are detached. It is used in conjunction with interconnecting rods and locking set screws. The Locking Set Screw is described as a low-profile, threaded cylindrical blocking plug featuring a specialized internal drive interface (e.g., T25 Torx) and an engineered buttress/truncated thread profile. The locking set screw is driven vertically down into the internal threads of the pedicle screw tulip head. It acts as a mechanical wedge that applies rigid, downward compressive force to trap and lock the longitudinal spinal rod, preventing construct migration under continuous biological loads. The screw is permanently implanted during spinal surgery, remains in the body long-term to prevent hardware migration, and is used in conjunction with pedicle screws and rods. You claim that the subject Polyaxial Pedicle Screws, MIS Extended-Tab Pedicle Screws, and Locking Set Screws are used in patients with severe degenerative disc disease (DDD), defined as chronic discogenic back pain with radiographic confirmation of degeneration, or degenerative spondylolisthesis. They are intended for use in patients with objective evidence of neurological impairment requiring internal stabilization or requiring rigid compression and secure hardware fixation. You further state that the screws are not used for temporary trauma fixation or general surgical purposes. They are specifically designed for the treatment of chronic spinal conditions and are used exclusively by trained orthopedic or neurosurgeons in spinal procedures. In your submission, you provide detailed explanations and evidence demonstrating that the CapLOX II® Pedicle Screw System and TowerLOX® MIS Pedicle Screw System are specifically designed for individuals with chronic or permanent physical impairments. These systems are fundamentally distinct from devices intended for temporary or general surgical trauma fixation. Physical Properties: Designed for Chronic Conditions, Not Temporary Trauma Fixation Unlike general orthopedic hardware or temporary trauma fixation devices (such as temporary bone plates, external fixators, or compression pins) that are designed to temporarily stabilize a fractured bone during natural healing, the CapLOX II® and TowerLOX® systems possess distinct characteristics for permanent, lifelong implantation. These systems are intended to address chronic, progressive structural failures of the spinal column. Biomechanical Fatigue Resistance: The system components are exclusively machined from biocompatible titanium alloy (Ti-6Al-4V ELI) in strict accordance with ASTM F136 specifications. This material is optimized for its elastic modulus and fatigue threshold, calibrated to permanently absorb multi-axial physiological weight-bearing forces (compression, torsion, bending) over decades without structural failure or material rejection. Anti-Loosening Thread Architecture: The locking set screws and tulip interiors feature a specialized thread profile engineered to resist cyclic mechanical loosening. Temporary trauma devices often use standard linear threads because they are designed for eventual removal. In contrast, the CapLOX II and TowerLOX thread configuration actively prevents outward expansion of the tulip walls (tulip splay) under the significant daily torque of the human trunk, thereby ensuring rigid, permanent alignment for life. Permanent System Integration: Adhering to the manufacturer's stringent safety criteria detailed in the Surgical Technique Manual, these devices are intended for permanent fixation. They are strictly contraindicated for mixing with dissimilar metals or alternative manufacturing lines due to risks of galvanic corrosion and mechanical tolerance issues, confirming their design for lifelong internal stability. Clinical Indications: Clarifying "Acute" vs. "Chronic" 1. Context of "Acute Instabilities" in FDA Labeling: The presence of terms such as “acute instabilities,” “fracture,” or “dislocation” within FDA 510(k) clearances and surgical technique manuals refers specifically to the clinical onset or etiology of severe structural breaches of the spinal column. When a patient sustains a complex spinal fracture or traumatic dislocation, the mechanical integrity of their central skeleton is instantaneously and permanently compromised. The CapLOX II® and TowerLOX® systems are never used as a temporary splint for a self-resolving, transient condition. Even when implanted for an “acute” event, the system functions as a permanent, lifelong structural scaffold to replace the compromised segment of the spinal column. 2. Evidentiary Baseline: Permanent Adjunct to Fusion: The primary and overarching indication for the CapLOX II® and TowerLOX® systems are their mandatory use as an adjunct to fusion (arthrodesis). The systems are explicitly designed to provide absolute, rigid mechanical immobilization across diseased or disrupted spinal segments while a permanent, irreversible bony bridge forms between adjacent vertebrae. This application is fundamentally different from transient surgical hardware. Once biological fusion is achieved, the titanium system becomes a permanent component of the patient's skeletal anatomy and is intentionally left inside the body permanently, unless rare, late-stage clinical complications necessitate intervention. 3. Commercial Allocation and Usage Metrics: Internal commercial and distribution tracking indicates that the systems is overwhelmingly utilized for chronic, progressive handicaps and degenerative conditions, rather than for emergency trauma scenarios. Distribution data reveals that over 99 percent of all CapLOX II® and TowerLOX® MIS components distributed nationwide are ordered by and delivered to specialized spine reconstruction surgeons treating permanent degenerative deformities, such as advanced degenerative spondylolisthesis with neurological deficits, chronic progressive scoliosis, severe kyphosis, and pseudarthrosis or failed previous spinal fusions. The applicable subheading for the Polyaxial Pedicle Screws, MIS Extended-Tab Pedicle Screws, and Locking Set Screws 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 for acute and chronic instabilities of the cervical and upper thoracic spine—medical conditions nearly identical to those treated by the CapLOX II® and TowerLOX® MIS Pedicle Screw Systems. You explain that the interbody fusion cage in HQ H359802 and the CapLOX II® or TowerLOX® MIS Pedicle Screw System are mechanically interdependent components of a unified spinal reconstruction construct. An interbody lumbar cage cannot achieve its intended clinical outcome—permanent bony fusion (arthrodesis)—without the rigid posterior fixation provided concurrently by pedicle screws, rods, and locking set screws, which prevent migration or collapse under continuous multi-axial physiological loads. You further state that whether used in tandem with an interbody fusion cage or as the primary mechanical constraint for a bone graft, the CapLOX II® or TowerLOX® MIS Pedicle Screw System is dedicated to the treatment of chronic spinal impairments. Since CBP has already determined that the interbody fusion cage is specially designed or adapted for the use or benefit of persons with chronic physical impairments under subheading 9817.00.96, HTSUS, the CapLOX II® or TowerLOX® MIS Pedicle Screw System as the matching posterior fixation system implanted in the same patient population during the same procedure for the same permanent duration, also qualifies for duty-free treatment under subheading 9817.00.96, HTSUS. Accordingly, the Polyaxial Pedicle Screws, MIS Extended-Tab Pedicle Screws, and Locking Set Screws that are components of the CapLOX II® or TowerLOX® MIS Pedicle Screw 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