VLIFT-s Vertebral Body Replacement System

{0}------------------------------------------------ January 10, 2019 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" below it. Stryker Spine Renee Norby Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401 Re: K183071 Trade/Device Name: VLIFT®-s Vertebral Body Replacement System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: PLR, MQP Dated: December 14, 2018 Received: December 17, 2018 Dear Ms. Norby: 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 {1}------------------------------------------------ 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, ### Melissa Hall -S For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K183071 Device Name VLIFT®-s Vertebral Body Replacement System #### Indications for Use (Describe) VLIFT®-s Vertebral Body Replacement System is indicated for use in the cervical spine (C3-C7) and the thoracolumbar spine (T1-L5) in skeletally mature patial or total replacement of a diseased, collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e., fracture), or for reconstruction following corpectorny performed to achieve decompression of the spinal cord and neural tissue in degenerative disorders. The VLIFT®-s Vertebral Body Replacement System is intended for use with autograft oone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The VLIFT®-s Vertebral Body Replacement System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion. The VLIFT®-s Vertebral Body Replacement System is intended to be used with FDA-cleared spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, anterior plate systems, and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------|----------------------------------------------------------| | <div><span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div>□ Over-The-Counter Use (21 CFR 801 Subpart C)</div> | 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}------------------------------------------------ ## stryker ## 510(k) Summary | 510(k) Summary: VLIFT®-s Vertebral Body Replacement System | | |------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Stryker Spine<br>2 Pearl Court<br>Allendale, NJ 07401 | | Contact Person : | Name: Renee Norby<br>Phone: 201-749-8074<br>Email: renee.norby@stryker.com | | Date Prepared: | January 7, 2019 | | Trade Name: | VLIFT®-s Vertebral Body Replacement System | | Common Name: | Spinal Vertebral Body Replacement Device | | Proposed Class: | Class II | | Classification Name: | Spinal Intervertebral Body Fixation Orthosis (21 CFR 888.3060) | | Product Code: | PLR, MQP | | Predicate Devices: | The VLIFT®-s Vertebral Body Replacement System was shown to be<br>substantially equivalent to the device listed below:<br><br>Primary Predicate:<br>Aesculap® Implant Systems, Inc., Modulift Vertebral Body Replacement (VBR) System, K172032 Additional Predicates: Zavation Normandy VBR System, K180673Globus Medical Inc., FORTIFY® Corpectomy Spacers, K162315Cardinal Spine, LLC, C-VBR, K152568NuVasive® Incorporated, NuVasive® X-Core® Mini Cervical Expandable VBR System, K151651Stryker Spine, VLIFT®-s Vertebral Body Replacement System, K091946Ulrich GmbH, Obelisc VBR, K060416 Reference Devices: Stryker Spine, AVS® AS PEEK Spacer, K120486Stryker Spine, Tritanium® C Anterior Cervical Cage, K171496 | | Device Description: | The VLIFT®-s Vertebral Body Replacement System is intended for use as an aid<br>in spinal fusion and consists of a single, pre-assembled distractible implant. The<br>device may be distracted continuously via an inner concentric ring. The hollow<br>core of the cage allows for packing bone graft. As the implant is distracted via<br>its inner concentric ring, additional slotted openings appear. | | | 510(k) Summary: VLIFT®-s Vertebral Body Replacement System | | | The VLIFT®-s cages are available in various diameters and heights. | | | Modular end caps snap into each end of the VLIFT®-s implant. Serrated teeth at<br>the rim of the end cap attachments help to anchor the implant to the end plates<br>of the vertebral bodies. The VLIFT®-s end caps are available in both flush and<br>contoured designs and are offered in a variety of angles. | | | Extension pieces are available for each diameter for the VLIFT®-s implants.<br>Extension pieces may be used to achieve the desired height. The use of<br>extension pieces is optional. | | Intended Use: | The Stryker Spine VLIFT®-s Vertebral Body Replacement System is indicated<br>for use in the cervical spine (C3-C7) and the thoracolumbar spine (T1-L5) in<br>skeletally mature patients for partial or total replacement of a diseased,<br>collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis,<br>trauma (i.e., fracture), or for reconstruction following corpectomy performed to<br>achieve decompression of the spinal cord and neural tissue in degenerative<br>disorders. | | | The VLIFT®-s Vertebral Body Replacement System is intended for use with<br>autograft or allogenic bone graft comprised of cancellous and/or<br>corticocancellous bone graft, as an adjunct to fusion. The VLIFT®-s Vertebral<br>Body Replacement System is also intended to restore the integrity of the spinal<br>column even in the absence of fusion for a limited time period in patients with<br>advanced stage tumors involving the cervical, thoracic, and lumbar spine in<br>whom life expectancy is of insufficient duration to permit achievement of<br>fusion, with bone graft used at the surgeon's discretion. | | | The VLIFT®-s Vertebral Body Replacement System is intended to be used with<br>FDA-cleared supplemental spinal fixation systems that have been labeled for<br>use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod<br>systems, anterior plate systems, and anterior screw and rod systems). When<br>used at more than two levels, supplemental fixation should include posterior<br>fixation. | | Summary of the<br>Technological<br>Characteristics | The subject VLIFT®-s Vertebral Body Replacement System and the predicate<br>was shown to be substantially equivalent based on material, design, and<br>mechanical performance. | | | The purpose of this 510(k) submission is to seek clearance for use in the<br>cervical spine. No changes have been made to the actual implants. | | 510(k) Summary: VLIFT®-s Vertebral Body Replacement System | | | Summary of the<br>Performance Data | The published clinical literature demonstrates the substantial equivalence of<br>VLIFT®-s Vertebral Body Replacement to other legally marketed cervical<br>vertebral body replacement devices. No changes were made to the existing<br>devices, nor were any new components added to the system. Therefore, no<br>additional testing was required or performed. | | Conclusion | The design features, materials used, manufacturing, and sterilization methods<br>are identical to the previously cleared VLIFT®-s Vertebral Body Replacement<br>System with the exception of broadening the indications to include the cervical<br>spine. Additionally, the design features, materials used, manufacturing, and<br>sterilization methods are similar to the predicates identified in this submission.<br>Based on information provided, the subject device has been determined to be<br>substantially equivalent to the predicate devices. | {4}------------------------------------------------ # stryker {5}------------------------------------------------ # stryker