OT:RR:CTF:VSP H353886 SS
Mr. T. Min James III
1629 K Street NW, 300
Washington, DC 20006
RE: Applicability of Subheading 9817.00.96, HTSUS, to VADER Pedicle System and
VADERone Pedicle System
Dear Mr. James:
This is in response to your request, on behalf of icotec AG, dated September 12, 2025, for
a binding ruling regarding the eligibility of the VADER Pedicle System and VADERone Pedicle
System for subheading 9817.00.96, Harmonized Tariff Schedule of the United States
(“HTSUS”), treatment. Our ruling is set forth below.
FACTS:
icotec AG is an FDA-registered Swiss company that specializes in the development and
distribution of spinal implant systems. The imported merchandise concerns icotec AG’s VADER
Pedicle System and VADERone Pedicle System, (together the “VADER Systems”). The
VADER Systems are implanted permanently into a patient’s spine to restore the integrity of their
spinal columns. The VADER Systems function similarly except the VADER Pedicle System
utilizes fenestrated screws to permit augmented fixation using bone cement injected into the
vertebral body after screw placement while the VADERone Pedicle System lacks fenestrated
screws and cannot be used with bone cement. The VADER Systems consist of polyaxial pedicle
screws and rods, made of icotec AG’s proprietary BlackArmor® carbon-fiber reinforced
polyetheretherketone (Carbon/PEEK) and/or titanium alloy. In addition to the screws and rods,
connectors are made of BlackArmor® Carbon/PEEK, and cross-links and nut screws are made of
titanium alloy. icotec AG states the VADER Systems work by stabilizing weakened or damaged
segments of the spine in patients who have spinal tumors and infections by anchoring
BlackArmor® Carbon/PEEK pedicle screws into the vertebrae, which are connected by rods.
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icotec AG explains that the VADER Systems relieve pressure on the spinal cord and nerves,
prevents further collapse or deformity, and enables patients to regain or preserve mobility and
function. Without such intervention, icotec AG submits that those affected would be unable to
perform basic life functions, such as standing, sitting upright, and walking, and would possibly
be left entirely immobile.
icotec AG states that the VADER Systems are used for patients with advanced stage
cancerous tumors causing such instability of the spine that spinal fusion surgeries are not an
option. Additionally, the VADER Systems are used for patients with severe spinal infections that
impair spinal stability, such as spondylodiscitis and osteomyelitis.
The VADER Systems include the following parts, which come in varying sizes to
conform to a patient’s spinal structure: nuts, cross links, straight and curved rods, polyaxial
screws, and axial and parallel connectors, which are composed of BlackArmor® Carbon/PEEK
or titanium alloy. All parts for the VADER Systems are manufactured by icotec AG solely for
use with the VADER Systems and must meet precise specifications and sterility requirements as
articles to be implanted permanently in the human body. icotec AG states that there is no other
use for the VADER Systems besides the uses noted above and the VADER Systems may only be
ordered by a prescribing physician and installed by a surgeon.
ISSUE:
Whether the VADER Systems imported by icotec AG are eligible for duty-free treatment
under subheading 9817.00.96, HTSUS.
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:
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,
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spontaneous, or natural.” Webster’s Third New International Dictionary 612 (unabr. 2002).
Subheading 9817.00.96 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.
Accordingly, eligibility within subheading 9817.00.96, HTSUS, depends on whether the
article in question 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. See subheading 9817.00.96, HTSUS; U.S. Note 4(b), Subchapter XVII, Chapter 98,
HTSUS. Note 4(a) to Chapter 98, HTSUS, provides:
(a) For purposes of subheadings 9817.00.92, 9817.00.94 and 9817.00.96, 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. This list of exemplar activities indicates
that the term “handicapped persons” is to be liberally construed so as to encompass a wide range
of conditions, provided the condition substantially interferes with a person’s ability to perform an
essential daily task. While the HTSUS and subchapter notes do not provide a proper definition
of “substantial” limitation, the inclusion of the word “substantially” denotes that the limitation
must be “considerable in amount” or “to a large degree.”
CBP has recognized several factors to be utilized and weighed against each other on a
case-by-case basis when determining whether a particular product is “specially designed or
adapted” for the benefit or use of handicapped persons. See U.S. Customs Serv. Implementation
of the Duty-Free Provisions of the Nairobi Protocol, Annex E, to the Florence Agreement, T.D.
92-77, 26 Cust. B. & Dec. 240, 241 (1992) (“Implementation of the Nairobi Protocol”) at 243-
244. These factors include: (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. See also Danze, Inc. v. United
States, Slip Op. 18-69 (Ct. Int’l Trade 2018); Sigvaris, Inc. v. United States, 227 F.Supp.3d 1327
(Ct. Int’l Trade, 2017), aff’d, 899 F.3d 1308 (Fed. Cir. 2018). The court in Sigvaris, 899 F.3d.
1308 (Fed. Cir. 2018), found that “[t]hese factors aid in assessing whether the subject
merchandise is intended for the use or benefit of a specific class of persons to a greater extent
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than for the use or benefit of others.” The court adopted these factors into its analysis.
Analysis of the five Sigvaris factors shows that that the VADER Systems are specifically
designed for the use of the handicapped. First, the VADER Systems consist of polyaxial pedicle
screws and rods, made of icotec AG’s proprietary BlackArmor® carbon-fiber reinforced
polyetheretherketone (Carbon/PEEK) and/or titanium alloy. The screws and rods are
complemented with connectors made of BlackArmor® Carbon/PEEK, and cross-links and nut
screws made of titanium alloy. As such, we find the VADER Systems possess design features
that distinguish them from ordinary screws and rods. Second, given the fact that the VADER
Systems must be surgically implanted by a surgeon into a patient’s spine, it is improbable that an
individual would seek out the VADER Systems unless they had physical disabilities, such as
spinal instability, that necessitated its use. Third, the importer has identified themselves as an
FDA-registered Swiss company that specializes in the development and distribution of spinal
implant systems. Fourth, the VADER Systems can only be ordered by prescribing physical and
then installed by a surgeon. Fifth, the submitted samples have specialized features that suggest
the articles are suitable for the handicapped.
This ruling is similar to previous rulings in which CBP has considered whether various
spinal implant devices are for the use of the handicapped. In New York Ruling Letter (NY)
N201418, dated February 17, 2012, CBP agreed with a secondary classification of Medtronic’s
Capstone Peek Spinal Fusion System, which was composed of pieces such as tantalum pins, as
well as other spinal fusion systems and pedicle screw systems, as articles specially designed or
adapted for the use or benefit of the handicapped in subheading 9817.00.96, HTSUS. In
addition, Headquarters Ruling Letter (HQ) H313200, dated November 9, 2020, CBP held that
tantalum pins used by surgeons to install spinal implant systems were essential components and
thus, were eligible for duty-free treatment under subheading 9817.00.96, HTSUS, as a part of an
article specially designed or adapted for the use or benefit of the handicapped. We have no
reason to question the decision in either ruling and we find the VADER Systems are similar to
the spinal fusion systems and pedicle screw systems that were integrated into patient’s
compromised spines to help with spinal stabilization and movement.
Subheading 9817.00.96, HTSUS, also excludes therapeutic and diagnostic articles. In
Richards Medical Co. v. U.S., 13 C.I.T. 519 (1989), “the Court {found} that the term
‘therapeutic’ distinguishes articles, which are used to heal the condition causing a handicap, from
those duty-free articles which are designed to compensate for, or adapt to, the handicapped
condition.” The court determined that a prosthetic hip was not a therapeutic article. Further, in
Travenol Lab. V. U.S., 17 C.I.T. 69 (1993), the court determined that, because kidney dialysis
does not restore the kidney function of a person with renal failure, it was not a therapeutic
procedure. Like prosthetic hip and dialysis articles, the VADER Systems help manage
but do not cure an underlying condition. Like the prosthetic hip, these systems simply help
manage spinal conditions. Therefore, the VADER Systems are eligible for duty-free treatment
under subheading 9817.00.96, HTSUS.
HOLDING:
The VADER Systems at issue are eligible for duty-free treatment under subheading
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9817.00.96, HTSUS, as articles specially designed or adapted for the use or benefit of the blind
or other physically or mentally handicapped persons.
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 on the internet at
https://hts.usitc.gov.
Please note that 19 C.F.R. § 177.9(b)(1) provides that “[e]ach ruling letter is issued on the
assumption that all of the information furnished in connection with the ruling request and
incorporated in the ruling letter, either directly, by reference, or by implication, is accurate and
complete in every material respect. The application of a ruling letter by a Customs Service field
office to the transaction to which it is purported to relate is subject to the verification of the facts
incorporated in the ruling letter, a comparison of the transaction described therein to the actual
transaction, and the satisfaction of any conditions on which the ruling was based.”
A copy of this ruling letter should be attached to the entry documents filed at the time the
goods are entered. If the documents have been filed without a copy, this ruling should be
brought to the attention of the CBP officer handling the transaction.
Sincerely,
Monika R. Brenner, Chief
Valuation and Special Programs Branch
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