Rule2026-11306
Medical Devices; Orthopedic Devices; Classification of the Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented or Uncemented Prosthesis
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 5, 2026
Effective
June 5, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is classifying the shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Full Text
<html>
<head>
<title>Federal Register, Volume 91 Issue 108 (Friday, June 5, 2026)</title>
</head>
<body><pre>
[Federal Register Volume 91, Number 108 (Friday, June 5, 2026)]
[Rules and Regulations]
[Pages 34152-34154]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-11306]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 888
[Docket No. FDA-2026-N-5830]
Medical Devices; Orthopedic Devices; Classification of the
Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem
Cemented or Uncemented Prosthesis
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is classifying the
shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem
cemented or uncemented prosthesis into class II (special controls). The
special controls that apply to the device type are identified in this
order and will be part of the codified language for classification of
the shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem
cemented or uncemented prosthesis. We are taking this action because we
have determined that classifying the device into class II will provide
a reasonable assurance of safety and effectiveness of the device. We
believe this action will also enhance patients' access to beneficial
innovative devices, in part by reducing regulatory burdens.
DATES: This order is effective June 5, 2026. The classification was
applicable on December 16, 2022.
FOR FURTHER INFORMATION CONTACT: Joseph Russell, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4566, Silver Spring, MD 20993-0002, 240-402-4210,
<a href="/cdn-cgi/l/email-protection#d298bda1b7a2bafc80a7a1a1b7bebe92b4b6b3fcbabaa1fcb5bda4"><span class="__cf_email__" data-cfemail="eda7829e889d85c3bf989e9e888181ad8b898cc385859ec38a829b">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA (the Agency or we) has classified the shoulder
joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or
uncemented prosthesis into class II (special controls), which we have
determined will provide a reasonable assurance of safety and
effectiveness of the device. In addition, we believe this action will
enhance patients' access to beneficial innovation, in part by reducing
regulatory burdens by placing the device into a lower device class than
the automatic class III assignment.
The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified into, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate device by means of the
procedures for premarket notification under section 510(k) of the FD&C
Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act (see also part 860, subpart D (21 CFR part 860, subpart D)).
Section 207 of the Food and Drug Administration Modernization Act of
1997 (Pub. L. 105-115) established the first procedure for De Novo
classification. Section 607 of the Food and Drug Administration Safety
and Innovation Act (Pub. L. 112-144) modified the De Novo
classification process by adding a second procedure. A device sponsor
may utilize either procedure for De Novo classification.
Under the first procedure, the person submits a premarket
notification (510(k)) for a device that has not previously been
classified. After receiving an order from FDA classifying the device
into class III under section 513(f)(1) of the FD&C Act, the person then
requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see section 513(f)(2)(B)(i) of the
FD&C Act). As a result, other device sponsors do not have to submit a
De Novo request or premarket approval application to market a
substantially equivalent device (see section 513(i) of the FD&C Act,
defining ``substantial equivalence''). Instead, sponsors can use the
less
[[Page 34153]]
burdensome 510(k) process, when necessary, to market their device.
II. De Novo Classification
For this device, FDA issued an order on April 30, 2020, finding the
Tornier Pyrocarbon Humeral Head not substantially equivalent to a
predicate not subject to PMA. Thus, the device remained in class III in
accordance with section 513(f)(1) of the FD&C Act when we issued the
order.
On February 8, 2022, FDA received Tornier SAS's request for De Novo
classification of the Tornier Pyrocarbon Humeral Head device. FDA
reviewed the request in order to classify the device under the criteria
for classification set forth in section 513(a)(1) of the FD&C Act.
We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness of the device, but there is sufficient information to
establish special controls that, in combination with the general
controls, provide reasonable assurance of the safety and effectiveness
of the device for its intended use (see section 513(a)(1)(B) of the
FD&C Act). After review of the information submitted in the request, we
determined that the device can be classified into class II with the
establishment of special controls. FDA has determined that these
special controls, in addition to the general controls, will provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, on December 16, 2022, FDA issued an order to the
requester classifying the device into class II. In this final order,
FDA is codifying the classification of the device by adding 21 CFR
888.3695.\1\ We have named the generic type of device ``shoulder joint
humeral (hemi-shoulder) ceramic head/metallic stem cemented or
uncemented prosthesis,'' and it is identified as a device using a
replacement humeral head made of ceramic materials such, as pyrolytic
carbon, and a stem made of alloys, such as cobalt-chromium-molybdenum.
It is intended to be implanted to replace the articular surface of the
proximal end of the humerus and to be fixed with or without bone cement
(21 CFR 888.3027). This device is not intended for use in total
shoulder arthroplasty.
---------------------------------------------------------------------------
\1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
---------------------------------------------------------------------------
FDA has identified the risks to health associated with this type of
device and the measures required to mitigate these risks in table 1.
Table 1--Risks to Health and Mitigation Measures for Shoulder Joint
Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented or
Uncemented Prostheses
------------------------------------------------------------------------
Identified risks to health Mitigation measures
------------------------------------------------------------------------
Adverse events of the index shoulder Clinical data; Non-clinical
including pain, unanticipated adverse performance testing; and
device effects, subsequent surgical Biocompatibility evaluation
interventions, wear of the native
bone, osteolysis, loosening and
migration, and revision including
revision due to device wear, component
dissociation, or device brittle
fracture.
Adverse tissue reaction due to......... Biocompatibility evaluation;
and Non-clinical performance
testing.
<bullet> Device materials..........
<bullet> Fretting and corrosion....
<bullet> Wear particulates.........
Infection.............................. Sterilization validation;
Reprocessing validation; Shelf
life testing; Pyrogenicity
testing; and Labeling.
Insufficient range of motion........... Non-clinical performance
testing.
------------------------------------------------------------------------
FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness of the device. For a device to
fall within this classification, and thus avoid automatic
classification in class III, it would have to comply with the special
controls named in this final order. The necessary special controls
appear in the regulation codified by this final order.
Under the FD&C Act, submission of a premarket notification under
section 510(k) is required to reasonably assure the safety and
effectiveness of class II devices unless FDA determines that the device
type should be exempt under section 510(m) of the FD&C Act. At this
time FDA has not made this determination for shoulder joint humeral
(hemi-shoulder) ceramic head/metallic stem cemented or uncemented
prostheses. This device is therefore subject to premarket notification
requirements under section 510(k) of the FD&C Act.
III. Analysis of Environmental Impact
The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not normally have a significant effect on the human
environment. Therefore, neither an environmental assessment nor an
environmental impact statement is required.
IV. Paperwork Reduction Act of 1995
This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections
of information in part 860, subpart D, regarding De Novo classification
have been approved under OMB control number 0910-0844; the collections
of information in 21 CFR part 814, subparts A through E, regarding
premarket approval have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding
premarket notification submissions have been approved under OMB control
number 0910-0120; the collections of information in 21 CFR part 820
regarding quality management system regulation have been approved under
OMB control number 0910-0073; and the collections of information in 21
CFR part 801 regarding labeling have been approved under OMB control
number 0910-0485.
[[Page 34154]]
List of Subjects in 21 CFR Part 888
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
888 is amended as follows:
PART 888--ORTHOPEDIC DEVICES
0
1. The authority citation for part 888 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 888.3695 to subpart D to read as follows:
Sec. 888.3695 Shoulder joint humeral (hemi-shoulder) ceramic head/
metallic stem cemented or uncemented prosthesis.
(a) Identification. A shoulder joint humeral (hemi-shoulder)
ceramic head/metallic stem cemented or uncemented prosthesis is a
device using a replacement humeral head made of ceramic materials such,
as pyrolytic carbon, and a stem made of alloys, such as cobalt-
chromium-molybdenum. It is intended to be implanted to replace the
articular surface of the proximal end of the humerus and to be fixed
with or without bone cement (Sec. 888.3027). This device is not
intended for use in total shoulder arthroplasty.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Clinical data must demonstrate that the device performs as
intended under anticipated conditions of use and include the following:
(i) Evaluation of improvement of shoulder function and reduction of
symptoms, including pain and function, for the indications for use; and
(ii) Evaluation of adverse events, including pain, unanticipated
adverse device effects, subsequent surgical interventions, wear of the
native bone, osteolysis, loosening and migration, and revision,
including revision due to device wear, component dissociation, or
device brittle fracture.
(2) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use and
include the following:
(i) Evaluation of the mechanical function (mechanical fatigue
strength including evaluation of fretting and corrosion, static
mechanical strength, modular component disassembly strength, and wear
analysis) and durability of the implant; and
(ii) Evaluation of worst-case device range of motion.
(3) All patient-contacting components of the device must be
demonstrated to be biocompatible.
(4) Performance data must support the sterility and pyrogenicity of
the device components intended to be sterile.
(5) Performance data must validate the reprocessing instructions
for the reusable components of the device.
(6) Performance data must support the shelf life of the device by
demonstrating continued sterility, package integrity, and device
functionality over the identified shelf life.
(7) Labeling must include the following:
(i) Validated methods and instructions for reprocessing of any
reusable components; and
(ii) A shelf life.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-11306 Filed 6-4-26; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on June 5, 2026.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.