XYcor® Expandable Spinal Spacer 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. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 24, 2016 Alphatec Spine, Incorporated Ms. Renée L. Murphy Senior Regulatory Affairs Specialist 5818 El Camino Real Carlsbad, California 92008 Re: K160646 Trade/Device Name: XY cor Expandable Spinal Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MQP Dated: July 25, 2016 Received: July 26, 2016 Dear Ms. Murphy: 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 Parts 801); medical device reporting (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, # 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) K160646 Device Name XYcor® Expandable Spinal Spacer System #### Indications for Use (Describe) When used as an Intervertebral Body Fusion device, the XY cor Expandable Spinal is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should have had six mon-operative treatment. The XY cor Expandable Spinal Spacer System is intended for use with autograft and with supplemental spinal fixation systems and that have been cleared by the FDA. When used as a Vertebral Body Replacement device, the XY cor Expandable Spinal Spacer System is intended for use in the thoracolumbar spine (TI-L5) to replace a collapsed, damaged or unstable partial or total vertebral body due to tumor or trauma (i.e. fracture). VBRs are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The XY cor Expandable Spinal Spacer System is intended for use with autograft and with supplemental spinal fixation systems and that have been cleared by the FDA. | Type of Use (Select one or both, as applicable) | |-----------------------------------------------------------------| | <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | | <span> 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: XYcor® Expandable Spinal Spacer System Manufacturer: Alphatec Spine, Inc., 5818 El Camino Real Carlsbad, CA 92008 USA Contact: Ms. Renée L. Murphy Senior Regulatory Affairs Specialist Phone: 760-494-6739 Prepared by: Mr. Justin Eggleton Director, Spine Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1331 H Street NW、12th Floor Washington, DC 20005 Phone: (202) 552-5800 jeggleton(@mcra.com Date Prepared: July 27, 2016 | Classification: | 21 CFR §888.3080, Intervertebral body fusion device<br>21 CFR §888.3060, Spinal intervertebral body fixation device | |-----------------|---------------------------------------------------------------------------------------------------------------------| | Class: | II | | Product Codes: | MAX, MQP | | Primary Predicate Device: | Alphatec Spine Novel Spinal Spacer System (K080699) | |---------------------------|---------------------------------------------------------------------------------------| | Additional Predicates: | Vertebration XYcor Spinal Implant (K082466)<br>Globus Medical LATIS Spacers (K123913) | #### Indications for Use: When used as an Intervertebral Body Fusion device, the XY cor Expandable Spinal Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients mav also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The XY cor Expandable Spinal Spacer System is intended for use with autograft and with supplemental spinal fixation systems and that have been cleared by the FDA. When used as a Vertebral Body Replacement device, the XY cor Expandable Spinal Spacer System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable partial or total vertebral body due to tumor or trauma (i.e. fracture). VBRs are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The X Ycor Expandable Spinal Spacer System is intended for use with autograft and/or allograft and with supplemental spinal fixation systems and that have been cleared by the FDA. {4}------------------------------------------------ ## Device Description: The XY cor Expandable Spinal Spacer System is an intervertebral body fixation system and vertebral body replacement consisting of implants with various widths, and lordosis to accommodate individual patient pathology. The devices are intended to deploy using Alphatec Spine instruments once placed into the spinal interbody space. System implants and instruments are manufactured from implant grade titanium (Ti-6AI-4V ELI per ASTM F136) and surgical grade stainless steel and silicone rubber respectively. These implants are intended for use with supplemental spinal fixation and bone graft. ## Comparison to Predicate Device: The subject XY cor Expandable Spinal Spacer System is substantially equivalent to the predicate Alphatec Spine Novel Spinal Spacer System (K080699), XYcor Spinal System (K082644), and the Globus Medical LATIS Spacers (K123913) with respect to technological characteristics of indications, design, materials, function, and performance. ## Substantial Equivalence: The subject XY cor Expandable Spinal Spacer System and the cited predicates are similar in design, material, and indications for use. An animal study was performed to evaluate fusion in a sheep model. A cadaver study was performed to validate the surgical technique and implantation of this device for the interbody cage indications. Mechanical testing was performed to demonstrate acceptable performance characteristics and substantial equivalence. ASTM F2077: Static Axial Compression. Static Compressive Shear. Static Torsion. Cyclical Axial Compression, Cyclical Compressive Shear, Cyclical Torsion Testing ASTM F266, Static Subsidence ASTM Draft Standard F-04.25.02.02, Static Expulsion Lateral and Flexion Extension Bending Subsidence #### Conclusion: The Alphatec Spine XY cor Expandable Spinal Spacer System includes implant and instrument design modifications and the indications for use have been expanded to include lumbar interbody fusion. The 510(k) demonstrates substantial equivalence to predicate devices.