(77 days)
The FortiBridge™ 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 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.
The FortiBridge™ System consists of implants and instruments for implantation. It is an anterior cervical plate and screw system which includes fixed and variable screws having standard, self-drilling or self-tapping tips, and one- through four-level plates. The implants are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient. The devices are sold sterile.
This document does not contain information about acceptance criteria or a study proving a device meets acceptance criteria in the context of an AI/ML medical device.
The provided text is a 510(k) premarket notification for the FortiBridge® Anterior Cervical Plate System, which is a physical spinal implant. The document details the device's indications for use, materials, and substantial equivalence to previously cleared predicate devices.
Specifically, page 5 states: "Performance data was not provided in this submission." This indicates that the submission relies on substantial equivalence to predicate devices rather than new performance data to demonstrate safety and effectiveness.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided text.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 26, 2016
Nanovis Spine, LLC % Karen E. Warden, Ph.D. President BackRoads Consulting, Inc. P.O. Box 566 Chesterland. Ohio 44026
Re: K162250
Trade/Device Name: FortiBridge® 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: October 3, 2016 Received: October 4, 2016
Dear Dr. 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. 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
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Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K162250
Device Name FortiBridge™ Anterior Cervical Plate System
Indications for Use (Describe)
The FortiBridge™ Anterior Cervical Plate System is interior screw fixation of the cervical spine (C2 to T1). The system is to be used as an adjunct to fusion for the treatment of dese (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 or scoliosis), pseudarthrosis or failed previous fusion.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
| Date: | 8 August 2016 |
|---|---|
| Sponsor: | Nanovis Spine, LLC |
| 5865 East State Rd. 14 | |
| Columbia City, Indiana 46725 USA | |
| (877) 907-6266 | |
| (260) 625-3834 | |
| Sponsor Contact: | Matthew Hedrick, CEO & Chief Operating Officer |
| 510(k) Contact: | Karen E. Warden, PhD |
| BackRoads Consulting | |
| PO Box 566 | |
| Chesterland, OH 44026 | |
| Office: 440.729.8457 | |
| Trade Name: | FortiBridge® 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 |
| Submission Purpose: | This submission modifies the sterilization and packaging state of theFortiBridge™ Anterior Cervical Plate System implants. These devices willbe available as sterile. |
| Device Description: | The FortiBridge™ System consists of implants and instruments forimplantation. It is an anterior cervical plate and screw system whichincludes fixed and variable screws having standard, self-drilling or self-tapping tips, and one- through four-level plates. The implants are availablein a variety of sizes to accommodate the individual anatomic and clinicalcircumstances of each patient. The devices are sold sterile. |
| Indications for Use: | The FortiBridge™ 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 degenerative disc disease (definedas neck pain of discogenic origin with the degeneration of the discconfirmed 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: | FortiBridge™ implants are manufactured from titanium alloy as described byASTM F136. |
| Primary Predicate: | FortiBridge™ System (Nanovis Spine, LLC - K143706) |
| Additional Predicate: | MaxAn® Anterior Cervical Plate System (Biomet Spine, LLC - K133518) |
| Performance Data: | Performance data was not provided in this submission |
| TechnologicalCharacteristics: | The FortiBridge™ System possesses the same technologicalcharacteristics as its predicate system. These include:• basic design,• material,• mode of operation and,• anatomic location |
Therefore the fundamental scientific technology of the FortiBridge™ System is the same as the previously cleared FortiBridge™ System.
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Conclusion:
The FortiBridge™ Anterior Cervical Plate System possesses the same
indications for use and technological characteristics as the predicate device. Therefore FortiBridge™ Anterior Cervical Plate System is substantially equivalent for its intended use.
§ 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.