Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System

{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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 16, 2016 Renovis Surgical Technologies, Incorporated % Sharyn Orton, Ph.D. Senior Consultant MEDIcept, Incorporated 200 Homer Avenue Ashland, Massachusetts 01721 Re: K153250 Trade/Device Name: Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE, ODP Dated: February 13, 2016 Received: February 16, 2016 Dear Dr. Orton: 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {1}------------------------------------------------ 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 yours, ## 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 510(k) Number (if known) K153250 #### Device Name Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System #### Indications for Use (Describe) The Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2-T1. Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation. The Renovis Tesera SC ACF System is a stand-alone system when used with the cover plate and screws provided, and requires no additional supplemental fixation. When used as a stand-alone system, the use of three (3) screws and the cover plate assembly. When used without the cover plate and three screws the Renovis Tesera SC ACF System is a non-stand-alone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability. Type of Use (Select one or both, as applicable) | <span style="font-family: Arial, sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | |-----------------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-family: Arial, sans-serif;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | #### 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}------------------------------------------------ #### Traditional 510(k) Summary as required by 21 CFR 807.92(a) K153250 - A ) Submitted by: Renovis Surgical Technologies Inc. 1901 W. Lugonia Ave. Ste 340 Redlands, CA 92374 Phone: 909-557-2360 Fax: 909-307-8571 - Official Contact: Anthony DeBenedictis Vice President of Quality Assurance - Consultant: Sharyn Orton, Ph.D. MEDIcept, Inc. 200 Homer Ave Ashland, MA 01721 Date prepared: 1-11-2016 B) Device Name: Intervertebral body fusion device with integrated fixation, cervical - Proprietary Name: Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System Device Class: Class II Regulation number: 21 CFR 888.3080 Intervertebral body fusion device Regulation name: - Product code: OVE - intervertebral fusion device with integrated fixation, cervical ODP - intervertebral fusion device with bone graft, cervical Classification panel: Orthopedic - C) Primary Predicate: K102547 Nuvasive CoRoent Small Interlock D) Device Description: The Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System includes the Tesera Trabecular Titanium (T3) cages, bone screws (self-drilling and self-tapping options) and anterior cover plate assembly. When used with the cover plate and screws, the Tesera SC ACF System requires no supplementary fixation systems. The screws protrude through the interbody portion of the device into the adjacent vertebral bodies, stabilize the vertebral body and reduce the likelihood of expulsion of the implant. The Tesera Trabecular Titanium (T3) cages have Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System Traditional 510k Premarket Notification {4}------------------------------------------------ ## NOWIE windows in the side for visualization of the bone graft. The accompanying cover plate is designed to resist screw back-out and must be used when the screws are implanted. When used without the cover plate and screws, the Tesera SC ACF cages require supplemental fixation. The Renovis Tesera SC ACF System cages are available in a variety of sizes (widths, height, depths, and bone screw sizes) to suit the individual pathology and anatomical conditions of the patient. The cages are additively manufactured then machined from Titanium alloy (Ti-6A1-4V). The bone screws are manufactured from Titanium alloy (Ti-6Al-4V) and the cover plate assembly is manufactured from Titanium alloy (Ti-6Al-4V) and Nitinol alloy. The implants are provided to the end user sterilized through gamma irradiation. The system also consists of reusable instrumentation used to implant the cages, screws, and cover plate assembly. The Renovis Tesera SC ACF System implants comply with the following material standards: - . ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications - ASTM F2063-12 Standard Specification for Wrought Nickel-Titanium Shape Memory ● Alloys for Medical Devices and Surgical Implants E) Indications For Use: The Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2-T1. Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation. The Renovis Tesera SC ACF System is a stand-alone system when used with the cover plate and screws provided, and requires no additional supplemental fixation. When used as a stand-alone system, the cages require the use of three (3) screws and the cover plate assembly. When used without the cover plate and three screws the Renovis Tesera SC ACF System is a non-stand-alone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability. - F) Substantial Equivalence Discussion Additional predicate devices include the Depuy/Synthes Zero P (K072981) and Centinel Spine Stalif-C (K072415). The Renovis Tesera SC ACF System cage is manufactured from different material than the predicate devices, but has a similar intended use, sizes, basic design, and function. The Renovis Tesera SC ACF System cage is manufactured using the same method (additive manufacturing) as the Renovis FDA cleared S128 ALIF (K131122; K140106) and S134 ALIF (K142095) which are reference devices. {5}------------------------------------------------ ### G) Performance Testing - Bench Mechanical testing of the Renovis Tesera SC ACF System included: - . Subsidence testing without screws per ASTM F2267-04 (reapproved 2011) Standard test method for measuring load induced subsidence of intervertebral body fusion device under static axial compression - Static Compression, Dynamic Compression, Static Shear Compression, Dynamic Shear . Compression. Static Torsion and Dynamic Torsion Testing per ASTM F2077-14 Test methods for intervertebral body fusion devices - Expulsion testing with and without screws per ASTM Draft Standard F04.25.02.02 Static ● Expulsion - . Cover plate assembly corrosion per ASTM F2129-08 Standard test method for conducting cyclic potentiodynamic polarization measurements to determine the corrosion susceptibility of small implant devices - Finite Element Analysis (cage) ● Sterilization, shelf life, and packaging studies have been previously conducted. #### Conclusion The Renovis Tesera SC ACF System has a similar Indication for Use, sizes, design, and function as the predicate devices. The Renovis Tesera SC ACF System has the same manufacturing process as the reference device. Differences between the Renovis Tesera SC ACF System and the predicate devices do not raise new issues of safety or effectiveness. The Renovis Tesera SC ACF System is substantially equivalent to the predicate devices. - H) Other Standards and Guidance - ASTM F983-86 (Reapproved 2013) Standard Practice for Permanent Marking of Orthopaedic Implant Components - ASTM F565-04 (Reapproved 2013) Standard Practice for Care and Handling of ● Orthopedic Implants and Instruments - . ASTM A564 - Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes - . Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Intervertebral Body Fusion Device, October 2007 - Guidance for Industry and FDA Staff: Spinal System 510(k)s", May 2004 ● - . Accepted into previous testing - ISO 11607-2: 2009 Packaging for terminally sterilized medical devices part 1: o requirements for materials, sterile barrier systems and packaging systems - Per ASTM F1980-07 Standard guide for accelerated aging of sterile . barrier systems for medical devices Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System Traditional 510k Premarket Notification {6}------------------------------------------------ # NOWIS - ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: o Requirements for development, validation and routine control of a sterilization process for medical devices - ISO 11137-2:2013 Sterilization of health care products Radiation Part 2: O Establishing the sterilization dose - ISTA 2A, 2011, Partial-Simulation Performance Test Procedure: Packaged o Products 150lb (68 kg) or Less - ASTM D4169:2009, Standard Practice for Performance Testing of Shipping O Containers and Systems - ISO 17665-1:2006 Sterilization of health care products Moist heat -- Part 1: O Requirements for the development, validation, and routine control of a sterilization process for medical devices.