CLA-2-OT:RR:NC:N3:135
Craig Lewis
Hogan Lovells US LLP
555 13th St. NW
Washington, DC 20004
RE: The eligibility of humeral stem forgings under the Nairobi Protocol treatment from an undisclosed
country
Dear Mr. Lewis:
In your letter dated January 8, 2026, you requested a tariff classification ruling on behalf of your client,
Advita Ortho, LLC. Samples were received, examined, and disposed of. The classification of the vitamin E
bar stock will be addressed under separate correspondence.
The products under consideration are Humeral Stem Forgings in varying lengths used to create Equinoxe®
press-fit primary humeral stems. The Humeral Stem Forgings are imported in an unfinished condition, but
they have already taken on the size and shape of the finished humeral stem. They enter the United States with
a pre-existing end use to be further processed via computer numerically controlled (“CNC”) machining into
the finished humeral stem. Specifically, the proximal face of each Humeral Stem Forging is machined to
create the mating feature for the humeral adaptor tray or replicator plate based on the intended shoulder
procedure. The forgings are hand polished using a buffing wheel, the polished and machined surfaces are
then masked, and the remaining exposed surface is sandblasted to create a higher friction surface which
interfaces with the recipient’s proximal humerus. The stem then undergoes a passivation process to remove
any impurities left from the physical production processes before it is laser-marked with product and lot
information and finally cleaned through an ultrasonic cleaning process. The finished humeral stem is then
packaged and undergoes a sterilization process via gamma irradiation before distribution.
The complete humeral stem is a component of the Equinoxe® Shoulder System, which allows surgeons to
replicate a patient’s unique anatomy by independently adjusting parameters in situ. Each component
effectively replaces a separate part of the patient’s shoulder anatomy to restore mobility and functionality.
The humeral stem replaces the internal load-bearing portion of the proximal humerus. It is inserted inside the
humeral canal and substitutes for the function of the removed or damaged humeral head and metaphyseal
bone during a shoulder arthroplasty.
In your submission you requested consideration of a classification under 9817.00.96, Harmonized Tariff
Schedule of the United Sates (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.
In New York Ruling NY 898509, dated June 22, 1994, CBP determined that unfinished femoral stems of hip
prosthesis systems that were the same shape as the finished products were classifiable under subheading
9817.00.96, HTSUS. Headquarters Ruling Letter (“HQ’) H346403, dated July. 18, 2025, states “unfinished
articles can qualify for duty-free treatment under subheading 9817.00.96, HTSUS, but the article must have
the essential character or essential shape of the qualifying, finished article.” In their imported condition, the
subject Humeral Stem Forgings possess the essential character of the finished humeral stems due to their size,
shape, and pre-determined use. A finished humeral stem is a key component of an artificial shoulder joint and
is used to replace the internal load-bearing portion of the proximal humerus during a shoulder arthroplasty
(shoulder replacement surgery). Furthermore, the U.S. Court of International Trade ruled that the hip
prostheses qualified for duty-free treatment under the Nairobi Protocol in Richards Medical Company v.
United States.720 F. Supp. 998 (CIT 1989). Accordingly, we find that the Humeral Stem Forgings are
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 Frequently Asked Questions on
the Trade Remedy/IEEPA page at
https://www.cbp.gov/trade/programs-administration/trade-remedies/IEEPA-FAQ.
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 [email protected].
Sincerely,
(for)
Denise Faingar
Designated Official Performing the Duties of the Division Director
National Commodity Specialist Division