RE: The tariff classification of bone cements from Germany

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 N365506 October 22, 2026 CLA-2-30:OT:RR:NC:N3: 143 CATEGORY: Classification TARIFF NO.: 3006.40.0000; 9817.00.96 Kimberly Atkinson Heraeus Medical LLC 770 Township Line Road Ste 300 Yardley, PA 19067-4232 RE: The tariff classification of bone cements from Germany Dear Ms. Atkinson: In your letter dated September 29, 2026, you requested a tariff classification ruling. The products under consideration are PALACOS® and PALACOS® PRO bone cements. The bone cements are standard-setting, high-viscosity, radiopaque cements made primarily of poly (methyl methacrylate) (PMMA). They contain zirconium dioxide as an X-ray contrast medium. Each bone cement consists of a polymer powder and a monomer liquid, which are mixed immediately before use at an approximate ratio of 68 percent powder to 32 percent liquid. Mixing produces a ductile dough that sets within a few minutes. The cement components in PALACOS® and PALACOS® PRO are the same. The principal difference is the packaging and handling system. Standard PALACOS® is mixed using a separate mixing device, while PALACOS® PRO is supplied in a closed system for mixing and application. The bone cement is intended for use by trained healthcare professionals in clinical settings. Because product performance and handling characteristics may vary based on temperature, humidity, and mixing technique, surgeons must be familiar with the products’ properties and instructions for use. The applicable subheading for the PALACOS ® and PALACOS ® PRO bone cements will be 3006.40.0000 Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Dental cements and other dental fillings; bone reconstruction cements.” The general rate of duty will be free. In your submission you also requested consideration of a 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. Based on the information provided, bone cement is used in joint-replacement surgeries for patients with osteoarthritis (OA) to provide continuous stability and fixation of the implant within the body. The PALACOS and PALACOS PRO bone cement are indicated for use in joint replacement procedures in hip, knee and other joints to fix plastic or metal prosthetic parts to living bone when reconstruction is necessary. OA is a progressive degenerative joint disease involving inflammatory and metabolic factors that can cause significant pain and impaired function. Over time, the pain may become constant and interfere with daily activities, including walking and other routine tasks. Although there is no cure for OA, joint replacement may help relieve pain and improve function, particularly when commonly affected joints, such as the hip or knee, are involved. When OA becomes severe and debilitating and conservative treatments no longer provide adequate relief, surgical treatment may be an appropriate standard option. OA is a common indication for arthroplasty, a procedure that replaces all or part of an affected joint. While there is no cure for OA, as it is a degenerative joint disease in cartilage and implants can replace the damaged joint surface to relieve pain and restore function, the underlying disease process remains affecting the individual from performing daily activities, including walking and other routine tasks. You indicate that the percentage of conditions treated bone cement is approximately 90 percent suffering from OA verses 10 percent of patients that only had a fracture. The use and marketing of these products are only permissible in patients who are receiving joint replacements as a result of OA or hip fracture or when reconstruction is necessary. You state that the cemented joint arthroplasty has high success rate and furthermore reduces the need for the use of painkillers such as opioids. Most implants last a lifetime and only 2.02% of patients will need at least a second surgery, while around 90% of patients are experiencing meaningful clinical improvement. Based on facts presented, we are of the opinion that bone cements, which are primarily used in patients with OA when conservative treatment fails to delay disease progression, are used to treat a condition that substantially limits major life activities, specifically walking, satisfy description set forth in Chapter 98, Subchapter XVII, U.S. Note 4(a). As such, the PALACOS and PALACOS PRO bone cements are eligible for duty-free treat 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 Dionisia Melman at dionisia.y.melman@cbp.dhs.gov. Sincerely, (for) James P. Forkan Director National Commodity Specialist Division