(324 days)
The Magnes-C™ Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2 to T1). The system is to be used as an adjunct to fusion for the following indications: 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), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumors, pseudarthrosis or failed previous fusion.
The Magnes-C™ Anterior Cervical Plate System components are intended for anterior screw fixation and stabilization of the cervical spine during the development of cervical interbody spinal fusion. The Magnes-C™ Anterior Cervical Plate System consists of one through three-level plates and fixed and variable screws, in a variety of sizes to accommodate individual patient anatomy. The Magnes-C components are provided nonsterile. Instruments to facilitate unilateral anterior fixation are included.
The provided text describes a medical device, the Magnes-C Anterior Cervical Plate System, and its clearance by the FDA. However, it does not include information about acceptance criteria for an AI/ML powered device, nor a study proving meeting such criteria. Instead, it details the indications for use, device description, materials, and mechanical testing results to demonstrate substantial equivalence to predicate devices for a spinal implant.
Therefore, I cannot provide the requested information regarding acceptance criteria and performance study for an AI-powered device based on the given text.
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March 1, 2023
Fellowship of Orthopaedic Researchers, Inc. % Dr. Karen Warden President BackRoads Consulting Inc. PO Box 566 Chesterland, Ohio 44026
Re: K221053
Trade/Device Name: Magnes-C Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: January 24, 2023 Received: January 26, 2023
Dear Dr. Karen Warden:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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542 of the Act); 21 CFR 1000-1050.
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 (QS) 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-
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,
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Colin O'Neill, M.B.E. 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
K221053
Device Name
Magnes-CTM Anterior Cervical Plate System
Indications for Use (Describe)
The Magnes-C™ Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2 to T1). The system is to be used as an adjunct to fusion for the following indications: 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), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumors, 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) |
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510(k) Summary
| Date: | 28 February 2023 |
|---|---|
| Sponsor: | Fellowship of Orthopaedic Researchers, Inc.320 Metairie Hammond Highway, Suite 406Metairie, LA 70005504-309-9845 |
| Sponsor Contact: | Stephen D. Cook, PhD, Executive Director |
| 510(k) Contact: | Karen E. Warden, PhDBackRoads ConsultingPO Box 566Chesterland, OH 44026Office: 440.729.8457 |
| Trade Name: | Magnes-C™ Anterior Cervical Plate System |
| Common Name: | Anterior cervical plate system |
| Regulatory Class: | Class II |
| Classification Name,Regulation, ProductCode: | Appliance, fixation, spinal intervertebral body, 888.3060, KWQ |
| Device Description: | The Magnes-C™ Anterior Cervical Plate System components are intendedfor anterior screw fixation and stabilization of the cervical spine during thedevelopment of cervical interbody spinal fusion. The Magnes-C™ AnteriorCervical Plate System consists of one through three-level plates and fixedand variable screws, in a variety of sizes to accommodate individual patientanatomy. The Magnes-C components are provided nonsterile. Instrumentsto facilitate unilateral anterior fixation are included. |
| Indications for Use: | The Magnes-C™ Anterior Cervical Plate System is intended for anteriorscrew fixation of the cervical spine (C2 to T1). The system is to be used asan adjunct to fusion for the treatment of the following indications:degenerative disc disease (defined as neck pain of discogenic origin withthe degeneration of the disc confirmed by history and radiographic studies),spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis,deformity (i.e., kyphosis, lordosis or scoliosis), tumors, pseudarthrosis orfailed previous fusion. |
| Materials: | The patient contacting portion of the Magnes-C™ Anterior Cervical PlateSystem implants are manufactured from titanium alloy as described byASTM F136. All instruments are manufactured from medical grade stainlesssteels according to ASTM F899, some of which have silicone or Radelhandles. |
| Primary Predicate: | Zavation Cervical Plate System (Zavation LLC – K130030) |
| Additional Predicates: | Cervical Spine Locking Plate (CSLP) (Synthes Spine – K945700), BiometMaxAn® Anterior Cervical Plate System (Biomet Spine LLC – K133518) |
| Performance Data: | Mechanical testing of the worst case Magnes-C™ Anterior Cervical PlateSystem construct was performed according to ASTM F1717 and includedstatic and dynamic compression and static torsion.The mechanical test results demonstrate that the Magnes-C™ AnteriorCervical Plate System device performance is substantially equivalent to thepredicate devices.Additionally, MR Compatibility testing per ASTM F2503 was performed. Theresults demonstrate that the Magnes-C™ Anterior Cervical Plate System |
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can be safely scanned in an MR system.
Technological The Magnes-C™ Anterior Cervical Plate System possesses the many of the same technological characteristics as the predicate devices. These include Characteristics: basic design, material, method of stabilization and anatomic location. Differences between the subject and predicate devices did not raise new questions of safety and effectiveness. Therefore the fundamental scientific technology of the Magnes-C™ Anterior Cervical Plate System devices is similar to previously cleared devices. The Magnes-C™ Anterior Cervical Plate System possesses the same Conclusion:
intended use and similar technological characteristics as the predicate devices. Therefore the Magnes-C™ Anterior Cervical Plate System is substantially equivalent for its intended use.
N/A