EL CAPITAN Anterior Lumbar Interbody Fusion System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. March 30, 2022 Astura Medical Parker Kelch Quality Manager 4949 W Royal Ln. Irving, Texas 75063 Re: K214047 Trade/Device Name: EL CAPITAN Anterior Lumbar Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: March 17, 2022 Received: March 17, 2022 Dear Parker Kelch: 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. 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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, for 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 510(k) Number (if known) K214047 Device Name EL CAPITAN ANTERIOR LUMBAR INTERBODY SYSTEM #### Indications for Use (Describe) The El Capitan Anterior Lumbar Interbody System is indicated for intervertebral body fusion procedures in sketally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiosraphic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). El Capitan System implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (0) months of non-operative weatment prior to treatment with an intervertebral cage. The EL CAPITAN Spacer and Plate assembly are an integrated interbody fusion device intended for stand-alone use when used with all titanium alloy screws. When used with anchors only the zero plate may be used and the assembly is intended for use with additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine. Hyperlordotic interbody devices (>20° lordosis) and the Oblique interbody devices must be used with supplemental fixation (e.g. posterior fixation) that has been cleared by the FDA for use in the lumbar spine. | Type of Use (Select one or both, as applicable) | | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------| | <table style="border:none"><tr><td><div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div></td><td><div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div></td></tr></table> | <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | | <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | | ## 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." {3}------------------------------------------------ ## 510(k) Summary: EL CAPITAN Anterior Lumbar Interbody Fusion | Date Prepared | March 16, 2022 | |------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitted By | Astura Medical | | | 4949 W Royal Ln | | | Irving, TX 75063 | | Contact | Parker Kelch | | | 4949 W Royal Ln | | | Irving, TX 75063 | | | Phone: 469-501-5530 x503 | | | Email: quality@asturamedical.com | | Trade Name | EL CAPITAN Anterior Lumbar Interbody Fusion System | | Common Name | Intervertebral body fusion device | | Classification Name | Intervertebral body fusion device - lumbar | | Class | II | | Product Code | OVD | | CFR Section | 21 CFR section 888.3080 | | Device Panel | Orthopedic | | Primary Predicate Device | EL CAPITAN Anterior Lumbar Interbody Fusion (K192492) | | Additional Predicate | Half Dome (K152512, K182877) | | Device(s) | Spinal Elements Lucent Magnum (K083475) | | Device Description | The El Capitan Anterior Lumbar Interbody devices are implants developed | | | for the substitution of the classical autogenous bone graft blocks. The | | | cages assist to avoid complications related to the bone graft donation site | | | (chronic pain, hematoma, infection, bone removal from the donor site | | | making it impossible to remove bone again, quality of the iliac bone, | | | accessing a healthy donor site that may become an unhealthy site, | | | hernias by the incision). The Spacers are a 2-piece modular design which | | | allows for interchangeable plate and spacer components. The plate and | | | spacer components contain interlocking features in addition to a spring- | | | loaded latch mechanism which allows for intraoperative assembly prior to | | | implantation. The spacer components are available in a range of | | | footprints and heights, and the plates are offered in multiple fixation | | | types and sizes to suit the individual pathology and anatomical conditions | | | of the patient. The implants have a hollow center to allow placement of | | | autogenous bone graft. The superior and inferior surfaces are open to<br>promote contact of the bone graft with the vertebral end plates, allowing | | | bone growth (arthrodesis). | | Materials | PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced) – MAF 2227 | | | Tantalum per ASTM F560 | | | Titanium Alloy (Ti6-AL4-V ELI) per ASTM F136 | | | Nitinol #1 (ASTM E2063) | | | | | Substantial Equivalence<br>Claimed to Predicate<br>Devices | The El Capitan Anterior Lumbar Interbody System is substantially<br>equivalent to the predicate devices in terms of intended use, design,<br>materials used, mechanical safety and performances. | | Indications for Use | The El Capitan Anterior Lumbar Interbody System is indicated for<br>intervertebral body fusion procedures in skeletally mature patients with<br>degenerative disc disease (DDD) of the lumbar spine at one or two<br>contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic pain<br>with degeneration of the disc confirmed by history and radiographic<br>studies. These DDD patients may also have up to Grade I spondylolisthesis<br>or retrolisthesis at the involved level(s). El Capitan System implants are to<br>be used with autogenous bone graft and supplemental fixation. Patients<br>should have at least six (6) months of non-operative treatment prior to<br>treatment with an intervertebral cage.<br><br>The EL CAPITAN Spacer and Plate assembly are an integrated interbody<br>fusion device intended for stand-alone use when used with all titanium<br>alloy screws. When used with anchors only the zero plate may be used<br>and the assembly is intended for use with additional supplemental<br>fixation that has been cleared by the FDA for use in the lumbar spine.<br><br>Hyperlordotic interbody devices (>20° lordosis) and the Oblique interbody<br>devices must be used with supplemental fixation (e.g. posterior fixation)<br>that has been cleared by the FDA for use in the lumbar spine. | | Non-clinical Test<br>Summary | The following analyses were conducted:<br>Static Compression ASTM F2077 Dynamic Compression ASTM F1717 Static Compression Shear ASTM F2077 Dynamic Compression Shear ASTM F1717 Subsidence ASTM F2267 Expulsion The results of these evaluations indicate that the El Capitan implants are<br>equivalent to predicate devices. | | Clinical Test Summary | No clinical studies were performed | | Conclusions: Non-Clinical<br>and Clinical | Astura Medical considers the El Capitan Anterior Lumbar Interbody<br>System to be equivalent to the predicate devices listed above. This<br>conclusion is based upon the devices' similarities in principles of<br>operation, technology, materials and indications for use. | In accordance with 21 CFR 807.92 of the Federal Code of Regulations {4}------------------------------------------------