Rampart One Lumbar Interbody Fusion Device

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, with flowing lines extending downward from the bottom profile. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 8, 2017 Spineology Inc. Jacqueline A. Hauge Regulatory Affairs Manager 7800 3rd Street N., Suite 600 Saint Paul, Minnesota 55128 Re: K163670 Trade/Device Name: Rampart One Lumbar Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: April 10, 2017 Received: April 11, 2017 Dear Ms. Hauge: 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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. {1}------------------------------------------------ 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" (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, # Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K163670 Page 1 of 1 Device Name Rampart One Lumbar Interbody Fusion Device ### Indications for Use (Describe) The standard and oblique Rampart One devices are integrated intervertebral body fusion devices indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months non-operative treatment. The standard and oblique Rampart One devices are designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and are intended for use with supplemental fixations systems cleared by FDA for use in the lumbar spine. 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) # 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 PRAStaff(@fda.hhs.gov "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}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the word "Spineology" in a bold, sans-serif font. To the right of the word is a purple graphic that looks like a cluster of dots arranged in a circular pattern. The logo appears to be for a company or organization named Spineology. | Date Prepared: | May 3, 2017 | |-----------------|-------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Spineology Inc.<br>7800 3rd Street North<br>Suite 600<br>Saint Paul, MN 55128<br>Establishment Registration Number: 2135156 | | Contact Person: | Jacqueline A. Hauge<br>Regulatory Affairs Manager<br>Phone: 651.256.8534<br>Fax: 651.256.8505<br>Email: jhauge@spineology.com | # Device Name and Classification | Trade Name: | Rampart One Lumbar Interbody Fusion Device | |--------------------|-------------------------------------------------------| | Common Name: | Intervertebral fusion device with integrated fixation | | Product Codes: | OVD | | Regulatory Class: | Class II | | Regulation Number: | 21 CFR 888.3080 | | Panel: | Orthopedic | | Predicate Devices | | | |-------------------|---------|-------------------------------------------------------------------| | Primary: | K153082 | Rampart A Lumbar Interbody Fusion Device (Spineology Inc.) | | Additional: | K111880 | Rampart P Lumbar Interbody Fusion Device (Spineology Inc.) | | | K160906 | Rampart A, O, T Lumbar Interbody Fusion Devices (Spineology Inc.) | | | K150321 | EVOS Lumbar Interbody Fusion Device (Cutting Edge Spine, LLC) | | | K072253 | SynFix LR (Synthes Spine) | | | K163543 | Durango Stand-Alone ALIF System (Biomet Spine) | #### I. Purpose The purpose of this premarket notification is to obtain initial 510(k) clearance of Spineology's Rampart One Lumbar Interbody Fusion Device. #### II. Submission History There have been no prior submissions submitted to FDA for the Rampart One Lumbar Interbody Fusion Device. {4}------------------------------------------------ #### III. Device Description Rampart One implants are intervertebral body fusion devices for use with bone graft in the intervertebral disc space to stabilize spinal segments as an adjunct to fusion. These devices are manufactured from PEEK-OPTIMA HA Enhanced (spacer), titanium alloy (face plate), and tantalum (radiopaque markers) materials. Rampart One devices incorporate integrated fixation in the form of titanium allov screws. Rampart One devices are provided in standard and oblique configurations. The standard device accommodates four screws and the oblique device accommodates two screws. In each device the screws are inserted through the anteriorly-located face plate into the adjacent vertebral bodies. Rampart One devices are provided in various heights and lordotic angles and contain a hollow core to receive autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Placement is achieved with an insertion instrument that allows for manipulation of the implant in the intervertebral disc space. #### IV. Indications for Use The standard and oblique Rampart One devices are integrated intervertebral body fusion devices indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months non-operative treatment. The standard and oblique Rampart One devices are designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and are intended for use with supplemental fixation systems cleared by FDA for use in the lumbar spine. #### V. Comparison to Predicate When compared to the predicate devices, Rampart One Lumbar Interbody Fusion Device has the same or similar: - Intended Use ● - . Indications for Use - . Fundamental Scientific Technology - Principle of Operation - Biological Safety ● - Base Materials - . Size Offering #### VI. Non-Clinical Testing The following mechanical testing was conducted in accordance with FDA's Class II Special Controls Guidance Document: Intervertebral Fusion Device (2007) and applicable American Society for Testing and Materials (ASTM) standards: | ASTM F2077 | ASTM F2267 | ASTM F543-13 | |----------------------------------------------------------------------------|--------------|-----------------| | • Static and Dynamic Compression<br>• Static and Dynamic Compression Shear | • Subsidence | • Axial Pullout | - . Static and Dynamic Compression Shear Anti-Screw Backout Expulsion Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011. #### VII. Conclusion Spineology has demonstrated that the Rampart One Lumbar Interbody Fusion Device is substantially equivalent to the predicate devices.