(38 days)
Not Found
No
The 510(k) summary describes a mechanical cervical plate system and its components, with no mention of AI or ML technology in the intended use, device description, or performance studies.
No.
The device acts as an adjunct to fusion for stabilization and fixation of the cervical spine, rather than directly providing therapy.
No
Explanation: The Artus™ cervical plate system is described as a medical device intended for anterior fixation and stabilization of the cervical spine as an adjunct to fusion. It is explicitly designed for treatment and stabilization, not for diagnosing conditions.
No
The device description clearly states it is a "cervical plate system" and describes physical components like plates and screws, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Artus™ cervical plate system is for anterior fixation of the cervical spine to provide stabilization as an adjunct to fusion. This is a surgical implant used directly on the patient's body.
- Device Description: The description details a physical implantable device (plates and screws) designed for surgical use.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such testing.
The information provided describes a medical device used in surgery, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
The Artus™ cervical plate system is intended for anterior fixation of the cervical spine (C2 to T1). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.
Product codes
KWQ
Device Description
Artus™ is a cervical plate system that provides one- through four-level standard plate designs as well as one- and two-level midline plates. The plates are designed with a blocking mechanism to restrict screw backout. The plating system offers a variety of screw options including self-drilling, self-tapping and self-drilling/self-tapping, all available in either fixed or variable designs and in standard and rescue diameters. The implants are available in a variety of lengths to accommodate the individual anatomic and clinical circumstances of each patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2 to T1)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing of the worst case Artus™ construct was performed according to ASTM F1717 and included dynamic compression bending. The test results demonstrate that Artus™ device mechanical performance is substantially equivalent to the predicate devices. This demonstrates that the Artus™ device performs as well as or better than the primary predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
uNion™ Cervical Plate System (ulrich medical USA – K150666)
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
September 14, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a blue square and the full name in a larger blue rectangle.
Ulrich GmbH & Co. KG % Hans Stover President & CEO Ulrich Medical USA 18221 Edison Avenue Chesterfield, Missouri 63005
Re: K202227
Trade/Device Name: Artus™ cervical plate system Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 7, 2020 Received: August 7, 2020
Dear Hans Stover:
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 (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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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).
Sincerely,
Colin O'Neill, M.B.E. Acting Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K202227
Device Name Artus™ cervical plate system
Indications for Use (Describe)
The Artus™ cervical plate system is intended for anterior fixation of the cervical spine (C2 to T1). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.
| 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) | ✓ Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|---|
| ✓ Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
| Date: | 7 August 2020 |
|---|---|
| Sponsor: | ulrich GmbH & Co. KG |
| Buchbrunnenweg 12 | |
| 89081 Ulm | |
| Germany | |
| Phone: +49 (0) 731-9654-1304 | |
| Fax: +49 (0) 731-9654-2802 | |
| Sponsor Contact: | Christoph Ulrich, Managing Partner |
| 510(k) Contact: | Hans Stover |
| ulrich medical USA, Inc. | |
| 18221 Edison Avenue | |
| Chesterfield, MO 63005 | |
| (636) 519-0268 Office | |
| (636) 519-0271 Fax | |
| Trade Name: | Artus™ cervical plate system |
| Common Name: | Anterior cervical plate system |
| Regulatory Class: | Class II |
| Classification | |
| Name, Regulation, | |
| Product Code: | Spinal intervertebral body fixation orthosis, 21 CFR 888.3060, KWQ |
| Device Descripion: | Artus™ is a cervical plate system that provides one- through four-level |
| standard plate designs as well as one- and two-level midline plates. The | |
| plates are designed with a blocking mechanism to restrict screw backout. | |
| The plating system offers a variety of screw options including self-drilling, | |
| self-tapping and self-drilling/self-tapping, all available in either fixed or | |
| variable designs and in standard and rescue diameters. The implants are | |
| available in a variety of lengths to accommodate the individual anatomic | |
| and clinical circumstances of each patient. | |
| Indications for Use: | The Artus™ cervical plate system is intended for anterior fixation of the |
| cervical spine (C2 to T1). The system is to be used to provide stabilization | |
| of the anterior cervical spine as an adjunct to fusion for the treatment of | |
| degenerative disc disease (defined as neck pain of discogenic origin with | |
| the degeneration of the disc confirmed by history and radiographic studies), | |
| spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal | |
| stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or | |
| failed previous fusion. | |
| Materials: | The Artus™ implants are manufactured from titanium alloy as described by |
| ASTM F136. | |
| Primary Predicate: | uNion™ Cervical Plate System (ulrich medical USA – K150666) |
| Performance Data: | Mechanical testing of the worst case Artus™ construct was performed |
| according to ASTM F1717 and included dynamic compression bending. | |
| The test results demonstrate that Artus™ device mechanical performance | |
| is substantially equivalent to the predicate devices. This demonstrates that | |
| the Artus™ device performs as well as or better than the primary predicate | |
| device. | |
| Technological | |
| Characteristics: | The Artus™ cervical plate system possesses the same technological |
| characteristics as the predicate device. These include basic design, | |
| material, method of stabilization and anatomic location. Therefore the | |
| fundamental scientific technology of the Artus™ cervical plate system | |
| devices is the same as previously cleared devices. | |
| Conclusion: | The Artus™ cervical plate system possesses the same intended use and |
| technological characteristics as the predicate devices. Therefore the | |
| Artus™ cervical plate system is substantially equivalent for its intended use. |
4