Keos Lumbar IBFD

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an image of three faces in profile, stacked on top of each other. The faces are stylized and appear to be looking to the right. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 15, 2016 Keos Mr. Mark F. Schenk Director of Ouality Assurance/Regulatory Affairs 1824 Colonial Village Lane Lancaster, Pennsylvania 17601 Re: K160631 Trade/Device Name: Keos Lumbar IBFD Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 14, 2016 Received: June 14, 2016 Dear Mr. Schenk: 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 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) K160631 Device Name Keos Lumbar IBFD #### Indications for Use (Describe) Keos Lumbar IBFD is indicated for spinal fusion procedure at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. DDD may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The Keos Lumbar IBFD is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e., posterior pedicle screws anterior plate systems, and anterior screw and rod systems). The device(s) is intended to be used with autogenous bone graft. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. The Keos Lumbar IBFD can be used in one of two methods: Transforaminal Lumbar Interbody Fusion (TLIF) Used as a TLIF, a single device is implanted in the appropriate location (L2-S1) to provide support for a transforminal approached surgery. Posterior Lumbar Interbody Fusion (PLIF) Used as a PLIF, two devices are implanted in the appropriate locations (L2-S1) to provided support to the spine for a posterior surgery. Type of Use (Select one or both, as applicable) | <div> <span style="font-size: 10pt;"> <span style="font-family: Symbol;"> ☑ </span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <span style="font-size: 10pt;"> <span style="font-family: Symbol;"> ☐ </span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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 section 807.92(c). | Submitter: | Keos<br>1824 Colonial Village Lane<br>Lancaster, PA 17601 | |----------------|-------------------------------------------------------------------------------------------------| | Contact Person | Mark F. Schenk<br>Director of QA/RA<br>Phone: 610-507-8255<br>Email: mfschenk@lokconsulting.net | | Date Updated | 5/26/16 | | Trade Name | Keos Lumbar IBFD | |---------------------------------------------|------------------------------------------------------| | Common Name | Intervertebral body fusion device | | Device Class | Class II | | Classification Name<br>and Number | Intervertebral Body Fusion Device<br>21 CFR 888.3080 | | Classification Panel: | Orthopedic | | Product Code | MAX | | Reason for 510k | New Device | | Primary Predicate | K080281, Custom Spine Pathway | | Additional Predicate<br>Device for Material | K150321, EVOS Lumbar Interbody System | | Device Description | The series of intervertebral body fusion devices are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. They are designed to be used in conjunction with supplemental spinal fixation instrumentation. The series is comprised of cages of various fixed heights and shapes for placement in the spine. There are different cages designed for specific regions of the spine and approaches to the spine. Each cage has a hollow center to allow placement of graft material inside of the cage. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.<br><br>The series of intervertebral body fusion devices are made from the PEEK radiolucent material and HA enhanced PEEK with embedded tantalum x-ray markers as specified in ASTM F2026 and ASTM F560, respectively. | |--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| {4}------------------------------------------------ | Indications for Use | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Keos Lumbar IBFD is indicated for spinal fusion procedure at one<br>or two contiguous levels (L2-S1) in skeletally mature patients<br>with degenerative disc disease (DDD). DDD is defined as discogenic<br>pain with degeneration of the disc confirmed by patient history and<br>radiographic studies. DDD may also have up to Grade 1<br>spondylolisthesis or retrolisthesis at the involved levels. These<br>patients may have had a previous non-fusion spinal surgery at the<br>involved spinal level(s). | | The Keos Lumbar IBFD is intended to be used with supplemental<br>spinal fixation systems that have been cleared for lumbosacral<br>spine (i.e., posterior pedicle screws and rod systems, anterior<br>plate systems, and anterior screw and rod systems). The<br>device(s) is intended to be used with autogenous bone graft. | | Patients should have at least six (6) months of non-operative<br>treatment prior to treatment with an intervertebral cage. | | The Keos Lumbar IBFD can be used in one of two methods: | | Transforaminal Lumbar Interbody Fusion (TLIF)<br>Used as a TLIF, a single device is implanted in the appropriate<br>location (L2-S1) to provide support for a transforaminal<br>approached surgery. | | Posterior Lumbar Interbody Fusion (PLIF)<br>Used as a PLIF, two devices are implanted in the appropriate<br>locations (L2-S1) to provided support to the spine for a posterior<br>surgery. | | Materials: | The implant is manufactured from ASTM2026 implant grade PEEK-<br>OPTIMA and PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced). | |------------|----------------------------------------------------------------------------------------------------------------------------| |------------|----------------------------------------------------------------------------------------------------------------------------| | Statement of<br>Technological<br>Comparison | Keos Lumbar IBFD and its predicate devices have the same indications for<br>use, similar design, and test results. Both devices are manufactured using<br>materials with a long history of use in orthopaedic implants. | |---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| {5}------------------------------------------------ | Nonclinical Test<br>Summary | The following tests were performed to demonstrate that the Keos Lumbar IBFD is<br>substantially equivalent to other predicate devices.<br><br>Static and Dynamic Compression Test per ASTM F2077 Static and Dynamic Compression Shear ASTM F2077 Subsidence Test per ASTM F2267 Static Expulsion Test<br>The results of these studies showed that the Keos Lumbar IBFD met the acceptance criteria. | |-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Clinical Test<br>Summary | No clinical tests were performed. | | Sterilization Information | | |---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Implants | The Implant will be shipped non-sterile and will be autoclaveable, validation testing of<br>the process was conducted (using the half-cycle method) to a Sterility Assurance Level<br>(SAL) of 10-6 per ISO 17665. | | Instruments and<br>Case | The instrument and case will be shipped non-sterile and will be autoclaveable,<br>validation testing of the process was conducted (using the half-cycle method) to a<br>Sterility Assurance Level (SAL) of 10-6 per ISO 17665. | | | The Keos Lumbar IBFD is substantially equivalent to its predicate devices. This | |------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Conclusion | conclusion is based upon the fact the Keos Cage and its predicate devices have the same indications for use, have a similar design and technical characteristics, similar test results, and any differences do not raise question of safety and effectiveness. |