KMTI S141 Lumbar Interbody Fusion System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font. August 30, 2021 Kyocera Medical Technologies, Inc. % Nathan Wright, M.S. Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918 Re: K212070 Trade/Device Name: KMTI S141 Lumbar Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: August 20, 2021 Received: August 23, 2021 Dear Nathan 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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For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, 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}------------------------------------------------ # 4. INDICATIONS FOR USE STATEMENT DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use 510(k) Number (if known) K212070 Device Name Kyocera Medical Technologies, Inc. (KMTI) S141 Lumbar Interbody Fusion System Indications for Use (Describe) The KMTI S141 Lumbar Interbody Fusion 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. Deqenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). KMTI S141 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 S141 System must be used with supplemental fixation cleared by FDA for use in the lumbar spine. | Type of Use (Select one or both, as applicable) | <span> <span style="padding-right: 20px;"> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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."* FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 {3}------------------------------------------------ | Submitter's Name: | Kyocera Medical Technologies, Inc. | |----------------------------|------------------------------------------------------------------------------------------| | Submitter's Address: | 1200 California St, Suite 210<br>Redlands, CA 92374 | | Submitter's Telephone: | 909-557-2360 | | Contact Person: | Nathan Wright MS<br>Empirical Testing Corp.<br>719-351-0248<br>nwright@empiricaltech.com | | Date Summary was Prepared: | July 1, 2021 | | Trade or Proprietary Name: | KMTI S141 Lumbar Interbody Fusion System | | Common or Usual Name: | Intervertebral body fusion device | | Classification: | Class II per 21 CFR §888.3080 | | Product Code: | MAX | | Classification Panel: | Orthopedic Devices | # 510(K) SUMMARY DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The Kyocera Medical Technologies, Inc. (KMTI) KMTI S141 Lumbar Interbody Fusion System (also called S141 LIF System) consists of cages which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion. The S141 LIF System includes the Tesera-P, Tesera-T, PEEK Straight TLIF, and PEEK TLIF families. The implants are offered in additively manufactured Titanium Alloy (Titanium-6Aluminum-4Vanadium) per ASTM F2924 and PEEK (Polyetheretherketone) per ASTM F2026.This submission updates the subject titanium alloy material specifications and standards, modifies the additive printing process, and expands the for the previously cleared S141 Lumbar Interbody Fusion System. The KMTI S141 Lumbar Interbody Fusion System is comprised of a variety of implant sizes to accommodate various patient anatomy and pathology, and associated instrumentation. The implants may be inserted via an open or minimally invasive approach. The Tesera P and PEEK PLIF use a posterior approach. The PEEK Straight TLIF, Tesera ST, and Tesera T use an oblique approach. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The superior and inferior surfaces of the Titanium Alloy implant consist of Tesera porous titanium structure to facilitate osseous integration. The superior and inferior surfaces of the S141 PEEK devices have "teeth" to help prevent the device from migration after surgically positioned. Additionally, the S141 PEEK devices contain tantalum markers (per ASTM F560) to assist the surgeon with proper placement of the device. The implants are provided terminally sterilized via gamma irradiation prior to end-user receipt. INDICATIONS FOR USE {4}------------------------------------------------ The KMTI S141 Lumbar Interbody Fusion 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 radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). KMTI S141 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 S141 System must be used with supplemental fixation cleared by FDA for use in the lumbar spine. The indications for use for the KMTI LIF System are identical to those of the primary predicate. ## TECHNICAL CHARACTERISTICS The purpose of this system is to expand the product line of the KMTI S141 Lumbar Interbody Fusion System with additional sizes offered and to modify the material and manufacturing method for the KMTI S141 devices which were previously cleared. The KMTI S141 Lumbar Interbody Fusion System is made from Ti-6A1-4V ELI per ASTM F136 or Ti-6Al-4V per F2924 or from PEEK per ASTM F2026 with tantalum per ASTM F560. 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 identical between the subject and predicates: - Indications for Use ● - Structural support mechanism ● - Sizes ● | 510k Number | Trade or Proprietary or Model<br>Name | Manufacturer | Predicate<br>Type | |------------------|--------------------------------------------------------|---------------------------------------------|-------------------| | K170888, K143126 | Renovis S141 Lumbar Interbody<br>Fusion System | Renovis Surgical<br>Technologies | Primary | | K181655 | Renovis S180 Lateral Lumbar<br>Interbody Fusion System | Renovis Surgical<br>Technologies | Additional | | K171657 | ShurFit 2C Lumbar Interbody<br>Fusion System | Precision Spine, Inc. | Additional | | K113561 | TM Ardis® Interbody System | Zimmer Trabecular<br>Metal Technology, Inc. | Additional | | K201605 | EIT Cellular Titanium® TLIF Cage | EIT Emerging Implant<br>Technologies GmbH | Additional | ### Table 5-1 Predicate Devices ## PERFORMANCE TESTING SUMMARY In support of this Special 510(k) Device Modification Premarket Notification, Kyocera Medical Technologies, Inc. has conducted mechanical testing to demonstrate that the modifications to the Kyocera Medical Technologies, Inc. S141 Lumbar Interbody Fusion System {5}------------------------------------------------ S141 Lumbar Interbody Fusion System provide adequate and substantially equivalent mechanical strength for their intended use. ### CONCLUSION The subject modified KMTI S141 Lumbar Interbody Fusion System is very similar to previously cleared Renovis S141 Lumbar Interbody Fusion System. The subject KMTI S141 Lumbar Interbody Fusion System has similar intended uses, indications, technological characteristics, and principles of operation as the predicate devices. The modifications raise no new types of safety or effectiveness questions. The overall technology characteristics and mechanical performance data lead to the conclusion that the KMTI S141 Lumbar Fusion System is substantially equivalent to the predicate devices.