N364676

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 f

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