SYPHER SPACER SYSTEM

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of human profiles facing right, suggesting a sense of community and care. The text is arranged in a circular pattern around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 19, 2015 Biogennix, LLC % Ms. Meredith May Empirical Consulting 4628 Northpark Drive Colorado Springs, Colorado 80918 Re: K141798 Trade/Device Name: Sypher Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MAX Dated: January 21, 2015 Received: January 23, 2015 Dear Ms. May: 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}------------------------------------------------ Page 2 - Ms. Meredith May 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) K141798 Device Name Sypher Spacer System #### Indications for Use (Describe) The Sypher Spacer System is an intervertebral body fusion system indicated for intervertebral body fusion procedures in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use with autogenous bone graft at one or two contiguous levels of the lumbar spine (from L2 to S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis 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 to facilitate fusion. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | <span style="font-size:12px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:12px">☐</span> 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}------------------------------------------------ # 5.510(K) SUMMARY | Submitter's Name: | Biogennix, LLC | |----------------------------|----------------------------------------------------------------| | Submitter's Address: | 18011 Sky Park Circle, Suite M<br>Irvine, CA 92614 | | Submitter's Telephone: | 949.253.0994 | | Contact Person: | Meredith L. May, MS<br>Empirical Testing Corp.<br>719.337.7579 | | Date Summary was Prepared: | 01-Jul-14 | | Trade or Proprietary Name: | Sypher Spacer System | | Common or Usual Name: | Intervertebral Fusion Device With Bone Graft, Lumbar | | Device Classification: | Class II per 21 CFR §888.3080 | | Product Code: | MAX | | Classification Panel: | Division of Orthopedic Devices | ### DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The Sypher Spacer System implants are cylinder shaped blocks made of PEEK Optima® LT1 (Polyether ether ketone per ASTM F2026), with tantalum alloy radiological position markers (per ASTM F560), titanium alloy self-drilling and self-tapping bone screws (per ASTM F136), and titanium alloy cage lock assemblies (per ASTM F136). The implants are available in a variety of footprints, heights and lordotic angles. The shape of the Sypher product allows for a larger implant (height and width) to be used allowing for more surface area contact. The Sypher Spacer System is offered in a closed graft space design. The implants incorporate integrated anterior screw holes to allow for medial placement of screws, as well as a titanium alloy cage lock assembly for securing the screws once in place. Additional or other supplemental fixation may be used, as patient needs dictate. The superior and inferior surfaces of the devices have a pattern of teeth to provide increased stability and to prevent movement of the implants. The Sypher Spacer System is intended to be used with autologous bone graft. #### INDICATIONS FOR USE The Sypher Spacer System is an intervertebral body fusion system indicated for intervertebral body fusion procedures in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use with autogenous bone graft at one or two contiguous levels of the lumbar spine (from L2 to S1) for the treatment of degenerative disc disease (DDD) with up to Grade I 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 to facilitate fusion. ### TECHNOLOGICAL CHARACTERISTICS Biogennix, LLC Sypher Spacer System {4}------------------------------------------------ Sypher Spacer System is made from PEEK Optima® LT1, Tantalum, and Titanium alloy that conforms to ASTM F2026, ASTM F560, and ASTM F136, respectively. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are similar or identical between the subject and predicates: - Intended Use - Materials of manufacture ● - Structural support mechanism ● - Indications for Use ● | Table 5-1 Predicate Devices | |-----------------------------| | | | 510k<br>Number | Trade or Proprietary or Model Name | Manufacturer | Predicate Type | |---------------------|-----------------------------------------------------|---------------|----------------| | K120031 | Chesapeake® Anterior-Lumbar<br>Stabilization System | K2M | Primary | | K100089 | T-PAL Spacer | Synthes | Additional | | K103034,<br>K130913 | Apache™ Lateral Lumbar Interbody<br>Fusion System | Genesys Spine | Additional | #### PERFORMANCE DATA The Sypher Spacer System has been tested in the following test modes: - Static axial compression bending per ASTM F2077-11 ● - o Static compressive shear per ASTM 2077-11 - Static subsidence per ASTM F2267-04 and ASTM 2077-11 ● - Dynamic axial compression per ASTM 2077-11 - Dynamic compressive shear per ASTM 2077-11 ● - Expulsion per ASTM Draft Standard F-04.25.02.02 The results of this non-clinical testing show that the strength of the Sypher Spacer System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices. ### CONCLUSION The overall technology characteristics and mechanical performance data lead to the conclusion that the Sypher Spacer System is substantially equivalent to the predicate device.