RE: Modification of NY A85213; Classification of a titanium alignment system for BK modular limb prostheses; Articles for the Handicapped; Subheading 9817.00.96, HTSUS

HQ H355932 June 15, 2026 OT:RR:CTF:VS H355932 TMF CATEGORY: Classification Mr. Dale Sprague Cascade Orthopedic Supply Incorporated P.O. Box 649 Chester, CA 96020 RE: Modification of NY A85213; Classification of a titanium alignment system for BK modular limb prostheses; Articles for the Handicapped; Subheading 9817.00.96, HTSUS Dear Mr. Sprague: This is in reference to a ruling issued to your company concerning the tariff classification of a titanium alignment system for below the knee (BK) modular limb prostheses from Sweden under the Harmonized Tariff Schedule of the United States (“HTSUS”). Specifically, in New York Ruling Letter (“NY”) A85213, dated July 25, 1996, U.S. Customs and Border Protection (“CBP”) determined that the titanium alignment system for BK modular limb prostheses was classified under subheading 9021.30.0000, HTSUS (Annotated), which provided for other artificial parts of the body and parts thereof. CBP also determined that the merchandise was not eligible for duty-free treatment under the subheading 9817.00.96, HTSUS. We have reviewed this ruling and find it to be in error regarding the applicability of subheading 9817.00.96, HTSUS. It is now CBP’s position that the subject titanium alignment system is eligible for duty-free treatment under subheading 9817.00.96, HTSUS. For the reasons set forth below, we are modifying NY A85213 as to the 1 eligibility under subheading 9817.00.96, HTSUS, as discussed below . 1 We note that after the issuance of NY A85213, subheading 9021.30, HTSUS, was subdivided and renumbered. The subject merchandise is now classified under subheading 9021.39.00, HTSUS.” This provision covers other artificial parts of the body and parts and accessories thereof that are not “***artificial joints*** and parts and accessories thereof.” (Emphasis added). Pursuant to section 625(c)(1), Tariff Act of 1930 (19 U.S.C. § 1625(c)(1)), as amended by section 623 of Title VI (Customs Modernization) of the North American Free Trade Agreement Implementation Act, Pub. L. No. 103-182, 107 Stat. 2057, 2186 (1993), notice of the proposed action was published on February 18, 2026, in Volume 60, Number 7, of the Customs Bulletin. No comments were received in response to this notice. FACTS: In NY A85213, CBP described the subject titanium alignment system for BK modular limb prostheses as consisting of a 30mm (diameter) tube adaptor (“pylon”) with integrated four screw alignment head and sliding adaptors for either a laminate or thermoplastic socket. The tube adaptor measured approximately 30 centimeters long. The ruling also states that a complete modular below-the-knee limb prosthesis generally consists of a prosthetic socket (including sheath for residual limb), a prosthetic foot, an adaptor which connects the prosthetic foot to the prosthetic socket, and cosmetic covers. At one time, limb prostheses were all made individually by hand using various materials. The introduction of modular prostheses brought many changes to the industry. Limb prostheses could be assembled from selected manufactured components to meet the special needs of an amputee. ISSUE: Whether the titanium alignment system for BK modular limb prostheses from Sweden is eligible for duty-free treatment under subheading 9817.00.96, HTSUS, as “articles specially designed or adapted for the handicapped.” LAW AND ANALYSIS: The Nairobi Protocol to the Agreement on the Importation of Educational, Scientific and Cultural Materials of 1982, Pub. L. No. 97-446, 96 Stat. 2329,2346 (1983) established the duty-free treatment for certain articles for the handicapped. Presidential Proclamation 5978 and Section 1121 of the Omnibus Trade and Competitiveness Act of 1988, provided for the implementation of the Nairobi Protocol into subheadings 9817.00.92, 9817.00.94, and 9817.00.96, HTSUS. 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.” In Sigvaris, Inc. v. United States, 227 F. Supp 3d 1327, 1336 (CIT 2017), aff’d, 899 F.3d 1308 (Fed. Cir. 2018), the U.S. Court of International Trade (“CIT”) explained that: 2 The term “specially” is synonymous with “particularly,” which is defined as “to an extent greater than in other cases or towards others.” Webster’s Third New International Dictionary 1647, 2186 (unabr. 2002). The dictionary definition for “designed” is something that is “done, performed, or made with purpose and intent often despite an appearance of being accidental, spontaneous, or natural.” Webster’s Third New International Dictionary 612 (unabr. 2002). 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. Thus, eligibility within subheading 9817.00.96, HTSUS, depends on whether the article is “specially designed or adapted for the use or benefit of the blind or physically and mentally handicapped persons,” and whether it falls within any of the enumerated exclusions under U.S. Note 4(b), Subchapter XVII, Chapter 98, HTSUS. 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. While the HTSUS does not establish a clear definition of substantial limitation, in Sigvaris, 227 F. Supp. 3d at 1335, the CIT explained that “[t]he inclusion of the word ‘substantially’ denotes that the limitation must be ‘considerable in amount’ or ‘to a large degree.’” We must first evaluate “for whose, if anyone’s, use and benefit is the subject article specially designed,” and then, whether “those persons [are] physically handicapped [].” Sigvaris, 899 F.3d at 1314. In other words, we must consider whether such persons are suffering from a permanent or chronic physical or mental impairment which substantially limits one or more major life activities. In this case, to be able to ambulate and walk are considered life activities. This system is suitable for persons who have experienced amputations and failed prior prosthetic implants, and it is beneficial because it allows them to adapt to their physical handicap and have continued walking mobility. People who have experienced below-knee amputations are persons who would benefit from this system. The Court of Appeals for the Federal Circuit (“CAFC”) clarified 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. This definition of ‘specially designed’ is consistent with factors that Customs uses in discerning for whose use and benefit a product is ‘specially designed’ ... we adopt them in our analysis ....” Id. at 1314–15. In Danze, Inc. v. United States, 319 F. Supp. 3d 1312, 1326 (CIT 2018), the CIT held that ADA compliance alone was insufficient to show that an item was “specifically designed or adapted” for the handicapped under subheading 9817.00.96, HTSUS. 3 Thus, to determine whether the titanium alignment system for BK modular limb prostheses is “specially designed” for the use or benefit of a class of persons to an extent greater than for others, we must examine the following five factors used by CBP and adopted by the CAFC in Sigvaris, 899 F.3d at 1314–15: (1) physical properties of the article itself (e.g., whether the article is easily distinguishable in design, form and use from articles useful to non-handicapped persons); (2) presence of any characteristics 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) importation by manufacturers or distributors recognized or proven to be involved in this class or kind of articles for the handicapped; (4) sale in specialty stores that serve handicapped individuals; and (5) indication at the time of importation that the article is for the handicapped. See also T.D. 92–77 (26 Cust. Bul. 240 (1992)). The first two factors to consider in determining whether an article is “specially designed” are the physical properties of the article and any characteristics of the article that easily distinguish it from articles useful to the general public. In this case, the subject alignment system is designed for persons who are amputees and need the prostheses for mobility. The titanium alignment system works because it is specially designed to connect the prosthetic to the lower part of the knee whereby the user will be able to stand, walk and fully ambulate without assistance. The connectivity is below the knee application. The loss of limb is considered to be a chronic physical impairment which substantially limits the ability to walk and ambulate, which are major life activities. The third and fourth factors to consider in determining whether an article is “specially designed” are whether it is imported by manufacturers or distributors recognized to be involved in this class or kind of articles for the handicapped and whether it is sold in specialty stores that serve handicapped individuals. In this case, the titanium alignment system is sold by Cascade Orthopedic Supply Incorporated, the requestor, which is a distributor of orthotics and prosthetics in North America. See https://www.cascade-usa.com/home. The fifth and final factor to consider is whether at the time of importation the article is for the handicapped. At the time of importation, this product is ready for installation by a prosthetist to an amputee’s limb. Further, the merchandise is conceptualized, designed, marketed and sold exclusively for an amputee. It is not for any other purpose and is not considered a part of another device (which we will discuss further below). Headquarters Ruling Letter (“HQ”) 555704, dated June 24, 1991, stated: “CBP considers the loss of a limb to be a permanent, physical impairment that requires the subject device in order for the amputee to adapt to the limb loss and maintain a level of mobility. The issue has been previously discussed as to whether prosthetics devices, used by individuals who need the articles to replace diseased extremities, are therapeutic in nature, and therefore precluded from duty-free treatment under U.S. Note 4(b).” 4 With respect to whether the subject titanium alignment system is therapeutic, we refer to Richards Medical Co. v. United States, 13 C.I.T. 519 (1989), which held that certain hip prosthetic articles were not therapeutic because they did not heal the handicapped person nor cure the disease which cause the handicap. In this case, the subject titanium alignment system’s functionality and purpose are not therapeutic in nature. Rather, it is prescribed for limb loss patients with the sole purpose of improving their quality of life by serving to facilitate walking and ambulation, both which are life activities. The subject titanium alignment system is similar to the prosthetics in Richards, supra as it is a therapeutic article that allows the user to adapt to the limb loss and still function; it is not a limb replacement, nor a cure for any underlying condition. See also Travenol Lab. v. United States, 17 C.I.T. 69 (1993), in which the court determined that kidney dialysis was not therapeutic because it did not restore the kidney function of a person with renal failure. Furthermore, the subject titanium alignment system is “specifically designed or adapted” for the handicapped and falls outside of the text “parts and accessories (except parts and accessories of braces and artificial limb prosthetics) that are specially designed or adapted for use in the foregoing…” to subheading 9817.00.96, HTSUS, which was added via Presidential Proclamation 6821, 60 Fed. Reg. 47,663 (1995), Its design and use is a significant adaptation, and not a generic part or accessory that is useable in other articles; rather, it is exclusively for use by the amputee community. In HQ 555704, dated June 24, 1991, CBP stated that prosthetic devices, though capable of use in conjunction with other prosthetic devices, are complete articles and not parts of articles. This ruling goes on to add: “[it is a] well known maxim that the mere fact that two articles are designed and constructed to be used together does not necessarily make either a part of the other.” Mattel, Inc. v. United States, 475 F.Supp. 683, 687 (Cust. Ct. 1979), rev’d on other grounds, 624 F.2d 1076 (C.C.P.A. 1980). In addition, “[i]t must be shown that the article claimed to be a part subserves an essential purpose in the thing for which it is destined, without which the article it is to be joined could not function as such article.” Westfield Manufacturing Company v. United States, 191 F. Supp. 578, 582 (Cust. Ct. 1961), aff’d, 49 C.C.P.A. 96 (1962); see also NY N289057, dated September 5, 2017, which found a prosthetic handset was eligible for duty-free treatment under subheading 9817.00.96, HTSUS. In NY N289057, CBP determined that the self-functioning prosthetic devices were eligible where their identity and primary use were clearly for handicapped persons. In sum, this system is functionally self- sufficient and is not a part. Finally, we find that the general public would never use this product. By virtue of its design alone, the subject article’s design and utility is in itself a significant adaptation that exclusively benefits the handicapped community. Accordingly, we find that the subject titanium alignment system for BK (below the knee) modular limb prostheses is an adaptive article that is exclusively designed for the handicapped and eligible for duty- free treatment under subheading 9817.00.96, HTSUS. 5 Accordingly, we determine that NY A85213, dated July 25, 1996, erroneously denied duty-free treatment under subheading 9817.00.96, HTSUS, to this product, and this ruling is modified. HOLDING: The titanium alignment system for BK modular limb prostheses is eligible for subheading 9817.00.96, HTSUS, which provides for as “articles specially designed or adapted for the use or benefit of the blind or other physically or mentally handicapped persons . . . other.” EFFECT ON OTHER RULINGS: NY A85213, dated July 25, 1996, is hereby MODIFIED as to the application of subheading 9817.00.96, HTSUS, treatment. In accordance with 19 U.S.C. §1625(c), this ruling will become effective 60 days after its publication in the Customs Bulletin. Sincerely, Yuliya A. Gulis, Director Commercial Trade and Facilitation Division 6