FORTICORE

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. To the left of the caduceus is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 5, 2014 Nanovis. LLC % Karen E. Warden, Ph.D. BackRoads Consulting, Incorporated 8202 Sherman Road Chesterland, Ohio 44026 Re: K140280 Trade/Device Name: FortiCore™ Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MAX Dated: August 1, 2014 Received: August 6, 2014 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {1}------------------------------------------------ Page 2 - Karen E. Warden, Ph.D. 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/Resourcesfor You/Industry/default.htm. 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 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 yours. Ronald#Alean -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use ## 510(k) Number (if known) ## K140280 Device Name FortiCore™ #### Indications for Use (Describe) When used as a cervical intervertebral body fusion device, FortiCore™ is intended for spinal fusion procedures in skeletally nature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the discorv and radiographic studies) at one spinal level from C2-T1. These patients should have had at least six weeks of non-operative treatment. FortiCore™ devices are to be used with autogenous bone graft and in combination with supplemental fixation indicated for cervical fusion procedures. When used as a lumbar intervertebral body fusion device, FortiCore™ is intended for spinal fusion procedures in skeletally mature patients with degenerative disc discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). FortiCore™ devices are to be used with autogenous bone graft and in combination with supplemental fixation indicated for lumbar spinal fusion procedures. Type of Use (Select one or both, as applicable) 区 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) {3}------------------------------------------------ # Section 8 - 510(k) Summary | Date: | 31 January 2014 | |-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sponsor: | Nanovis, LLC<br>5865 East State Rd. 14<br>Columbia City, Indiana 46725 USA<br>(877) 907-6266<br>(260) 625-3834 | | Contact Person: | Matthew Hedrick, CEO & Chief Operating Officer | | Trade Name: | FortiCore™ | | Common Name: | Interbody fusion device | | Device Classification | Class II | | Classification Name: | Intervertebral body fusion device | | Regulation: | 888.3080 | | Device Product<br>Codes: | ODP, MAX | | Device Description: | FortiCore™ consists of implants and instruments for implantation.<br>The upper and lower aspects of the implant are open and have an<br>integrated titanium scaffold which assists in securing the implant in<br>the intervertebral space. The devices are available in a variety of<br>sizes to accommodate the individual anatomic and clinical<br>circumstances of each patient. | | Intended Use: | When used as a cervical intervertebral body fusion device,<br>FortiCore™ is intended for spinal fusion procedures in skeletally<br>mature patients with degenerative disc disease (defined as neck pain<br>of discogenic origin with degeneration of the disc confirmed by<br>history and radiographic studies) at one spinal level from C2-T1.<br>These patients should have had at least six weeks of non-operative<br>treatment. FortiCore™ devices are to be used with autogenous bone<br>graft and in combination with supplemental fixation indicated for<br>cervical fusion procedures.<br>When used as a lumbar intervertebral body fusion device,<br>FortiCore™ is intended for spinal fusion procedures in skeletally<br>mature patients with degenerative disc disease (defined as<br>discogenic back pain with degeneration of the disc confirmed by<br>history and radiographic studies) at one or two contiguous spinal<br>levels from L2-S1. These patients should have had six months of<br>nonoperative treatment. These patients may have had a previous<br>non-fusion spinal surgery and/or may have up to Grade 1<br>spondylolisthesis or retrolisthesis at the involved spinal level(s).<br>FortiCore™ devices are to be used with autogenous bone graft and<br>in combination with supplemental fixation indicated for lumbar spinal<br>fusion procedures. | | Materials: | FortiCore devices are manufactured from polyetheretherketone<br>(PEEK-OPTIMA® LT1, Invibio®) as described by ASTM F2026. The<br>integrated scaffold (BioSync-Ti, Sites Medical) is manufactured from<br>CP titanium as described by ASTM F67. | | Predicate Devices: | Nanovis Intervertebral Body Fusion System, (Nanovis LLC,<br>K110442) | | | Zeus Lumbar Intervertebral Body Fusion Devices (Amendia,<br>K081614) | | Performance Data: | Mechanical testing of the worst case FortiCore™ devices was<br>performed according to ASTM F2077 and included static and<br>dynamic compression and static and dynamic torsion. Subsidence<br>testing according to ASTM F2267 was performed on the worst case<br>FortiCore devices. | | | Shear and tension testing were performed according to ASTM F1044<br>and F1147, respectively, to evaluate the metal polymer interface.<br>The mechanical test results demonstrate that the FortiCore device<br>performance is substantially equivalent to the predicate devices. | | Technological<br>Characteristics: | FortiCore possesses the same technological characteristics as the<br>predicate devices. These include: performance (as described above), basic design (hollow structural frame), implant grade materials (PEEK polymer and titanium), and sizes (widths, lengths and heights are within the range(s) offered by the predicates). | | | Technological characteristics which are different have been<br>supported with descriptive information and/or performance data.<br>Therefore the fundamental scientific technology of the FortiCore<br>devices is the same as previously cleared devices. | | Conclusion: | FortiCore possesses the same intended use and technological<br>characteristics as the predicate devices. Therefore FortiCore is<br>substantially equivalent for its intended use. | {4}------------------------------------------------