RE: The tariff classification of Metalogix Revolution External Plating System from China

U.S. Department of Homeland Security U.S. Customs and Border Protection National Commodity Specialist Division One World Trade Center, Suite 51.201 New York, NY 10007 U.S. Customs and Border Protection N364676 September 21, 2026 CLA-2-90:OT:RR:NC:N3 135 CATEGORY: Classification TARIFF NO.: 9021.10.0090 Boping Shan Fusion Orthopedics USA, LLC 6859 E Rembrandt Ave Ste122 Mesa, AZ 85212 RE: The tariff classification of Metalogix Revolution External Plating System from China Dear Mr. Shan: In your letter dated August 27, 2026, you requested a tariff classification ruling. The Metalogix Revolution External Plating System is a modular external fixation platform consisting mainly of plates including foot, I, n, J, and C plates; tibial blocks, including cascade and stacked tibial blocks; forefoot bridges, posts, threaded rods, SuperStruts, wires, half-pins, fixation hardware, including nuts, bolts, and washers; and related instrumentation. It is a versatile external fixation system indicated for treatment of a variety of broken or deformed bones. The components are assembled by the surgeon to create patient-specific external fixation constructs used to stabilize bone, correct deformities, support arthrodesis/fusion procedures, facilitate limb reconstruction, and provide prolonged stabilization during healing. The previous request letter states that the system is for use in the stabilization of both acute conditions, such as fracture and trauma, and chronic conditions, including deformity correction, joint fusion (arthrodesis), nonunion or delayed healing, bone loss, and soft tissue reconstruction. It further explains that while the device is indicated for both categories, the nature and purpose of external fixation are predominately associated with the chronic cases. In acute trauma cases, external fixation is typically used as a temporary stabilization method, often serving as a bridge to subsequent definitive internal fixation. In contrast, in chronic conditions, the Metalogix Fixation System is used as a definitive, long-term reconstructive solution, addressing structural deformity, instability, and functional impairment. You claim that the Revolution External Plating System includes several features that make it suitable for patients with chronic or permanent physical impairments requiring complex foot, ankle, or limb reconstruction. You explain in the following: The system is designed as a modular external fixation platform. Plates are secured to bone using wires or half-pins, and plates may be connected to other plates using threaded rods or SuperStruts. The SuperStruts allow angular adjustment, compression, distraction, and frame positioning, which supports deformity correction, alignment restoration, fusion, and complex reconstruction. The system also includes foot plates, welded stacked tibial blocks, welded cascade tibial blocks, forefoot bridges, posts, and walker rails. These components allow the surgeon to build foot and ankle frame constructs for conditions requiring prolonged stabilization and structural correction. The foot plates include multiple rows of holes for hardware placement and dedicated walker rail mounting holes. The walker rail is designed to follow the natural gait and support patient mobility during treatment. You state that these features are particularly relevant to chronic conditions such as Charcot neuroarthropathy, chronic foot and ankle deformity, arthrodesis/fusion, nonunion or delayed union, bone loss, diabetic wound care/offloading, and complex reconstruction. In these cases, the device is not merely used as temporary fracture stabilization; rather, it functions as a long-term reconstructive frame to stabilize bone, correct deformity, support healing, preserve limb function, and help restore or maintain mobility. You assert that the Revolution External Plating System is specially designed and adapted for use in patients with chronic or permanent physical impairments because its design and clinical application address conditions that substantially limit mobility, weight-bearing, balance, and independent ambulation. Supporting evidence includes the system’s indications for treatment of deformed bones, fusion of joints and bones, correction of bone or soft tissue deformities, correction of bone loss, and stabilization of complex conditions. Your company’s internal utilization analysis indicates that approximately 77% of reviewed Metalogix system configurations correspond to Charcot-oriented reconstruction applications. A Charcot case study shows that the components used for the Charcot reconstruction include a tibial block, n-plates, SuperStruts, foot plate, forefoot bridge, posts, and bolts. You explain that, unlike simple acute fracture stabilization, these chronic reconstructive applications require prolonged stabilization, deformity correction, alignment restoration, fusion support, offloading, and limb preservation. The system’s modular frame components, foot plate constructs, walker rails, adjustable SuperStruts, wires, half-pins, and tibial block configurations are specially adapted to support these long-term reconstructive needs. The high percentage of Charcot-related cases further confirms that the system’s principal use is directed toward chronic disabling conditions rather than temporary or transient acute conditions. The applicable subheading for the Revolution External Plating System will be 9021.10.0090, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Orthopedic appliances, including crutches, surgical belts; splints and other fracture appliances … Orthopedic and fracture appliances, and parts and accessories thereof: Other.” 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 and accessories 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. Online research indicates that the Revolution External Plating System serves the same core medical purpose and clinical use as traditional circular external fixation, with the distinction that the Revolution External Plating System uses a modified, open-ring design rather than fully closed circles. The Revolution External Plating System is marketed as an evolution of the traditional circular external fixation systems. It is modified into a modular, open ring external fixation system to improve surgical access, operative time, and patient experience. Both systems are rooted in the principles of Ilizarov fixation, a foundational orthopedic technique that uses externally connected frames, tensioned wires, and half-pins to stabilize bone from the outside. Circular external fixation is a general orthopedic treatment platform, not inherently an article for handicapped persons. The surgical technique includes “TRAUMA FRAME ASSEMBLY” examples for distal/proximal/mid-tibial shaft fractures and distal tibial fractures. Fractures are generally temporary or transient acute conditions. Your company’s internal utilization analysis shows that approximately 77% of 113 reviewed orders contained Charcot-oriented configurations, but the methodology expressly states that this is a configuration proxy and not confirmed patient diagnosis evidence. It also states the analysis “should not be described as 87 confirmed Charcot diagnoses unless independently validated from clinical indication records.” The spreadsheet does not prove that 87 orders were actually confirmed for Charcot patients. The submitted documents and additional information found online do not establish that the Revolution External Plating System qualifies for subheading 9817.00.96, HTSUS. The available documents, including the FDA 510(k) letter, surgical technique guide, your company’s internal utilization analysis, brochure, and instructions for use, as well as your website and other online resources, show that the Revolution External Plating System is a broad, versatile orthopedic external fixation system indicated for a variety of broken and deformed bones. While many of these applications may involve chronic or permanent impairments, the system is marketed and indicated as an all-in-one, versatile external fixation system for both acute fractures and trauma and chronic reconstructive conditions. The available information does not demonstrate that the system is specially designed or adapted for the use or benefit of handicapped persons within the meaning of subheading 9817.00.96, HTSUS. Its similarity to circular external fixation further indicates that it is a general orthopedic fixation platform. Accordingly, the Revolution External Plating System is not eligible for duty-free treatment under subheading 9817.00.96, HTSUS. 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