Genesys Spine Apache Interbody Fusion System

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 26, 2016 Genesys Spine Mr. Dave Lamb Vice President of Compliance 1250 South Capitol of Texas Highway, Building 3, Suite 600 Austin, Texas 78746 Re: K153123 Trade/Device Name: Genesys Spine Apache® Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 23, 2016 Received: March 29, 2016 Dear Mr. Lamb: 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/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 yours, # Lori A. Wiggins -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 STATEMENT DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use 510(k) Number (if known) K153123 #### Device Name Genesys Spine Apache® Interbody Fusion System #### Indications for Use (Describe) The Genesys Spine Apache@ Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine. from L2 to S1, in skeletally mature patients who had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Type of Use (Select one or both, as applicable) > 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}------------------------------------------------ # 510(k) Summary | Submitter's Name: | Genesys Spine | |------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter's Address: | 1250 Capital of Texas Highway South<br>Building Three, Suite 600<br>Austin, Texas 78746 | | Submitter's Telephone: | 512-381-7094 | | Submitter's Fax: | 800-817-4938 | | Contact Name: | Dave Lamb | | Date Summary was<br>Prepared: | April 22, 2016 | | Trade or Proprietary Name: | Genesys Spine Apache® Interbody Fusion System | | Common or Usual Name: | Intervertebral Fusion Device | | Classification: | Class II per 21 CFR §888.3080 | | Product Codes: | MAX | | Classification Panel: | Orthopedic and Rehabilitation Devices Panel | | Legally Marketed<br>(unmodified) device: | Primary Predicate: Genesys Spine Interbody Fusion<br>System (K103034)<br>Additional Predicates: K2M Aleutian IBF System<br>(K082698); Alphatec Epicage Interbody Fusion System<br>(K130548); Custom Spine, Inc Pathway ELIF (K143143);<br>Medtronic Sofamor Danek Perimeter Interbody Fusion<br>Device (K090353 & K111525); Spine Works Anterior<br>Lumbar Device (K133340); Medtronic Sofamor Danek<br>CAPSTONE Spinal System (K073291) | # DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The Genesys Spine Apache® Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of a Genesys Spine interbody fusion device, which may be implanted as a single device via: - Bi-laterally via a posterior (PLIF) approach ■ - As a single device via a transforaminal (TLIF) approach or ■ - I As a single device via an anterior/anterolateral (ALIF) approach. The system implant components are made of polyether ether ketone (PEEK Optima LT1) that conforms to ASTM F2026. Additionally the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device. {4}------------------------------------------------ ## INDICATIONS FOR USE The Genesys Spine Apache® Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of nonoperative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. ## TECHNICAL CHARACTERISTICS The Genesys Spine Apache® Interbody Fusion System is comprised of various device configurations designed to accommodate patient anatomy and provide the surgeon with different surgical approach options. The Genesys Spine Apache® Interbody Fusion System implant components are made of polyether ether ketone (Invibio PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device. The additional implant offering being proposed has similar technological characteristics and identical indications as the currently cleared product line. ## PERFORMANCE DATA The Genesys Spine Apache® Interbody Fusion System was tested in static subsidence per ASTM F2267-04 and static expulsion per ASTM draft standard F-04.25.02.02. Confirmatory testing, Cross-Sectional Area calculations, and validated FEA analysis showed that a new worst-case device was not created when compared the predicate Genesys Spine Interbody Fusion System (K103034). The performance data were sufficient to allow for a substantial equivalence designation for the subject device. ### CONCLUSION The overall technology characteristics and mechanical performance data lead to the conclusion that Genesys Spine Apache Interbody Fusion System is substantially equivalent to the Genesys Spine Interbody Fusion System (K103034), K2M Aleutian IBF System (K082698), Alphatec Epicage Interbody Fusion System (K130548). Custom Spine, Inc Pathway ELIF (K143143), Medtronic Sofamor Danek Perimeter Interbody Fusion Device (K090353 & K111525), Spine Works Anterior Lumbar Device (K133340), and the Medtronic Sofamor Danek CAPSTONE Spinal System (K073291). As a result of the testing and analysis performed a result of substantially equivalence was determined.