LDR Spine ROI-C Cervical Cage System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 faces in profile, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 17, 2015 LDR Spine USA Mr. Brad Strasser Manager, U.S. Regulatory Affairs 13785 Research Boulevard, Suite 200 Austin, Texas 78750 Re: K150765 Trade/Device Name: LDR Spine ROI-C Cervical Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: August 20, 2015 Received: August 21, 2015 Dear Mr. Strasser: 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 – Mr. Brad Strasser 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" (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 vours. 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) K150765 Device Name LDR Spine ROI-C Cervical Cage System #### Indications for Use (Describe) The LDR Spine ROI-C Cervical Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The LDR Spine ROI-C Cervical Cage System is to be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft and placed via an open, anterior approach. Supplemental internal fixation is required to properly utilize this system. Type of Use (Select one or both, as applicable) | <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | |--------------------------------------------------------------------------------------------------------------------------------| | <span style="font-size: 10pt;"> <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}------------------------------------------------ # 510(k) Summary | Device Trade Name: | LDR Spine ROI-C Cervical Cage System | |--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer: | LDR Spine USA<br>13785 Research Boulevard, Suite 200<br>Austin, TX 78750<br>Phone: (512) 344-3333<br>Fax: (512) 344-3350 | | Contact: | Mr. Brad Strasser<br>Manager, U.S. Regulatory Affairs<br>Phone: (512) 344-3395 | | Prepared by: | Mr. Justin Eggleton<br>Musculoskeletal Clinical Regulatory Advisers, LLC<br>1331 H Street NW, 12th Floor<br>Washington, DC 20005<br>Phone: (202) 552-5800<br>jeggleton@mcra.com | | Date Prepared: | September 15, 2015 | | Classifications: | 21 CFR §888.3080, Intervertebral body fusion device | | Class: | II | | Product Codes: | OVE | ## Indications For Use: The LDR Spine ROI-C Cervical Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The LDR Spine ROI-C Cervical Cage System is to be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft and placed via an open, anterior approach. Supplemental internal fixation is required to properly utilize this system. #### Device Description: The LDR Spine ROI-C Cervical Cage System consists of 'D' shaped blocks in a variety of heights and length x width configurations, and features an enclosed graft space. Lateral rows of teeth are present on both the caudal and cephalic surfaces of the flat of the 'D' shape represents the anterior most portion of the device, and includes features for attachment to instrumentation for insertion, and the slots for the anchors. {4}------------------------------------------------ The D-shaped ROI-C PEEK implants (PEEK OPTIMA LT1) feature two slots which allow for use with specially designed supplemental fixation - the ROI-C VerteBRIDGE anchoring plate. The anchoring plate, made of titanium alloy (TiA16V4) can be inserted to obtain fixation to the vertebral bone and create a standalone cervical interbody fusion cage construct. The anchoring plate locks securely in place to the PEEK implant via locking tabs on either side of the anchoring plate. The ROI-C PEEK cages are available in two shapes - an anatomic design with a curved superior surface and a lordotic design with flat superior and inferior surfaces to create 7° of lordosis. The device is manufactured from medical grade PEEK OPTIMA® LT1 The purpose of the subject 510(k) was to expand the indications to include use with allograft. ## Predicate Device: The subject LDR Spine ROI-C Cervical Cage System is substantially equivalent to the primary predicate LDR Spine ROI-C Cervical Cage System (K113559) with respect to indications, design, function, and materials. An additional (secondary) predicate device was cited in the 510(k), which was the Amedica® Corporation Valeo™ Spacer System (K142264). ## Substantial Equivalence: The LDR Spine ROI-C Cervical Cage System and primary predicate LDR Spine ROI-C Cervical Cage System (K113559) are similar in design, materials, and indicated use, and are both cleared devices. The LDR Spine ROI-C Cervical Cage System and additional (secondary) predicate Amedica® Corporation Valeo™ Spacer System (K142264) are similar in design, and indicated use, and are both cleared devices. #### Performance Testing: Comprehensive, clinical literature review data have been provided to investigate the risks and benefits associated with using allogenic bone graft with the LDR Spine ROI-C Cervical Cage System. The published clinical outcomes demonstrated that the use of allograft (i.e., cancellous and/or corticocancellous bone graft) in cervical interbody fusion devices to treat patients diagnosed with cervical degenerative disc disease as defined above, poses no new risks to patients. No new mechanical tests were performed since there were no design changes to the device. #### Conclusion: The LDR Spine ROI-C Cervical Cage System has been modified to expand the indications to permit use with allograft. The 510(k) demonstrates substantial equivalence to predicate devices.