PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System

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April 21, 2023 Kyocera Medical Technologies, Inc. % Nathan Wright, MS Engineer & Regulatory Specialist Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918 Re: K230808 Trade/Device Name: PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: March 23, 2023 Received: March 23, 2023 Dear Mr. Wright: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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Sincerely, Brent Showalter -S Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use Submission Number (if known) K230808 Device Name PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System #### Indications for Use (Describe) The KMTI PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S 1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radio graphic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). KMTI PEEK SA ALIF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The KMTI PEEK SA ALIF System is a stand-alone device and is intended to be used with the cover plate and screws provided and requires no additional supplementary fixation. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided. Should the surgeon choose to use fewer than the four screws provided, additional supplemental fixation cleared by the FDA for use inthe lumbar spine must be used. Supplemental fixation, cleared by the FDA for use inthe lumbosacral spine, must be used with implants ≥ 20°. Type of Use (Select one or both, as applicable) X 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}------------------------------------------------ # 10. 510(K) SUMMARY | Submitter's Name: | Kyocera Medical Technologies, Inc. | |--------------------------------|-------------------------------------------------------------------------------------------------------------------------------| | Submitter's Address: | 1200 California Street<br>Suite 210<br>Redlands, CA 92374 | | Submitter's Telephone: | 909-557-2360 | | Contact Person: | Nathan Wright MS<br>Empirical Technologies<br>719-351-0248<br>nwright@empiricaltech.com<br>Image: Empirical Technologies Logo | | Date Summary was Prepared: | March 23 2023 | | Trade or Proprietary Name: | PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System | | Device Classification Name: | Intervertebral Fusion Device with Integrated Fixation, Lumbar | | Classification & Regulation #: | Class II per 21 CFR §888.3080 | | Product Code: | OVD | | Classification Panel: | Orthopedic Devices - Spinal Devices (DHT6B) | ## DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The KMTI PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System consists of PEEK cages, titanium screws, and a titanium cover plate. The KMTI PEEK SA ALIF System cages are intended to be used with the bone screws, the anterior cover plate assembly (cover plate), and do not require supplementary fixation systems unless less than four bone screws are utilized or cage lordosis is ≥20°. The screws protrude through the interbody portion of the cage implant and stabilize the vertebral body while preventing expulsion of the cage implant. The KMTI PEEK SA ALIF System offers hexalobe drive with both fixed and variable angle screw options. The fixed angle screw option provides a tighter fit with the cage than the variable angle screws while the variable angle screw option provides more clearance between the screw than the fixed screw, which allows for a small amount of screw angulation. The accompanying cover plate is designed to resist screw back-out and must be used when the screws are implanted. The cover plate assembly and screw are part of the implant construct. The KMTI PEEK SA ALIF System cages are available in a variety of sizes to suit the individual patient anatomical needs. The purpose is to offer non-sterile packaging for cage sizes in the PEEK SA ALIF System (formerly S128 ALIF System) previously cleared for sterile packaging only. # INDICATIONS FOR USE The KMTI PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radio graphic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). KMTI PEEK SA ALIF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of nonoperative treatment. The KMTIPEEK SA ALIF System is a stand-alone device and is intended to be used with {4}------------------------------------------------ the cover plate and screws provided and requires no additional supplementary fixation. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided. Should the physician choose to use fewer than the four screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used. Supplemental fixation, cleared by the FDA for use in the lumbosacral spine, must be used with implants ≥20°. # TECHNOLOGICAL CHARACTERISTICS The subject and predicate have identical technological characteristics. There are no differences between the subject and predicate devices that raise questions regarding the safety and effectiveness of the subject device. Specifically, the following characteristics are identical between the subject and predicates. - Indications for Use - . Principle of Operation - Structural Support Mechanism - Materials of Manufacture ● - Sterilization - Sizes ● ### Predicate Devices | 510k Number | Trade or Proprietary or Model Name | Manufacturer | Predicate Type | |-------------|-----------------------------------------------------|-----------------------------------|----------------| | K180502 | S128 Anterior Lumbar Interbody Fusion (ALIF) System | Renovis Surgical Technologies Inc | Primary | | K131122 | S128 Anterior Lumbar Interbody Fusion (ALIF) System | Renovis Surgical Technologies Inc | Additional | ## PERFORMANCE DATA Performance testing was not required in this submission for the modifications proposed. Changes in sterilization were validated according to ISO 17665-1. ## CONCLUSION The overall technology characteristics are identical between the subject and predicates which leads to the conclusion that the PEEK SA ALIF System is substantially equivalent to the predicate device.