(26 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an anterior cervical plate intended for fixation to the cervical spine to address various conditions such as degenerative disc disease, spondylolisthesis, and spinal stenosis. This indicates it is used for treatment and management of medical conditions.
No
The device, Elegance® Anterior Cervical plate, is described as a surgical implant for anterior fixation to the cervical spine, designed to restore intervertebral height and lordosis. Its intended use and device description clearly indicate it is a therapeutic or reconstructive device, not one used for diagnosis.
No
The device description explicitly states it is a cervical plate system made of titanium alloy, including plates, screws, and locking systems, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Elegance® Anterior Cervical plate is a physical implant designed for surgical fixation of the cervical spine. It is a structural device, not a diagnostic test.
- Intended Use: The intended use is for anterior fixation to the cervical spine to treat various conditions. This is a therapeutic intervention, not a diagnostic process.
- Lack of Diagnostic Elements: The description does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
The Elegance® Anterior Cervical plate is a surgical implant used for spinal fixation.
N/A
Intended Use / Indications for Use
The Elegance® Anterior Cervical plate is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:
- Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies)
- Spondylolisthesis
- Spinal stenosis
- Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
- Pseudoarthrosis
- Revision of previous surgery
Product codes
KWQ
Device Description
The Elegance® Anterior Cervical plate is designed for use as a cervical plate system. The device has a shape which restores the intervertebral height and lordosis. The Elegance® Anterior Cervical plate consists in a variety of shapes and sizes of cervical plates with rounded corners, featuring bone screw's holes, locking systems and bone screws. The plates go from one (1) to five (5) levels, and the screws are self-drilling or self-tapping, and fixed or variable. The fixation is provided by the bone screws inserted into the vertebral body by means of an anterior approach. The Elegance® plates, as well as the bone screws, are made of compliant ASTM F136 Titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine from C2 to C7
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The subject Elegance® Anterior Cervical plate has been tested in the following tests:
- Static Torsion Test (ASTM F1717)
- Axial Compression (ASTM F1717)
- Dynamic Compression (ASTM F1717)
The results of this non-clinical testing show that the subject Elegance® Anterior Cervical plate is substantially equivalent to legally marketed predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
January 14, 2025
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Clariance Quang Tran Clinical & Ouality & Regulatory Affairs VP 18. rue Robespierre Beaurains, 62217 France
Re: K243904
Trade/Device Name: Elegance® Anterior Cervical plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: November 29, 2024 Received: December 19, 2024
Dear Quang Tran:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Ethan R. Naylor -S
for Ronald P. Jean, Ph.D. Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Elegance® Anterior Cervical plate
Indications for Use (Describe)
The Elegance® Anterior Cervical plate is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:
-
- Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies)
-
Spondylolisthesis
-
Spinal stenosis
-
Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
-
Pseudoarthrosis
-
Revision of previous surgery
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(K) SUMMARY
CLARIANCE's Elegance® Anterior Cervical plate
Submitter
Clariance 18 rue Robespierre 62217 Beaurains, France
Phone: + 33(0)3 21 16 12 15
Contact Person: Quang TRAN, Quality Assurance, Regulatory Affairs and Clinical VP Date Prepared: November 29th, 2024
Name of Device: Elegance® Anterior Cervical plate
Common or Usual Name: Appliance, Fixation, Spinal Intervertebral Body
Classification Name: Spinal intervertebral body fixation orthosis, 21 CFR § 888.3060
Regulatory Class: Class II
Product Code: KWQ
Predicate Device: Aggeris™-C, CLARIANCE (K220182)
Device Description
The Elegance® Anterior Cervical plate is designed for use as a cervical plate system. The device has a shape which restores the intervertebral height and lordosis. The Elegance® Anterior Cervical plate consists in a variety of shapes and sizes of cervical plates with rounded corners, featuring bone screw's holes, locking systems and bone screws. The plates go from one (1) to five (5) levels, and the screws are self-drilling or self-tapping, and fixed or variable. The fixation is provided by the bone screws inserted into the vertebral body by means of an anterior approach. The Elegance® plates, as well as the bone screws, are made of compliant ASTM F136 Titanium alloy.
Intended Use / Indications for Use
The Elegance® Anterior Cervical plate is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:
-
Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies)
-
Spondylolisthesis
-
- Spinal stenosis
-
- Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
-
- Pseudoarthrosis
-
- Revision of previous surgery
5
Summary of Technological Characteristics
The subject and predicate (K220182) devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicate:
- · Same material (ASTM F136 Titanium alloy)
- · Same plate lengths and curvatures
- · Same manufacturing process.
Performance Data
The subject Elegance® Anterior Cervical plate has been tested in the following tests:
- · Static Torsion Test (ASTM F1717)
- · Axial Compression (ASTM F1717)
- · Dynamic Compression (ASTM F1717)
The results of this non-clinical testing show that the subject Elegance® Anterior Cervical plate is substantially equivalent to legally marketed predicate device.
Conclusions
Elegance® Anterior Cervical plate has the same intended use and indications, principles of operation and similar technological characteristics as the cleared Aggeris™-C (K220182). In addition, the minor technological differences between the Elegance® Anterior Cervical plate and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that Elegance® Anterior Cervical plate is as safe and effective as the cleared Aggeris™-C (K220182). Thus, the subject Elegance® Anterior Cervical plate is substantially equivalent to the cleared Aggeris™-C (K220182).