EL CAPITAN Anterior Lumbar Interbody Fusion

{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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 19, 2023 Astura Medical Parker Kelch Quality Manager 4949 W Royal Ln. Irving, Texas 75063 Re: K222554 Trade/Device Name: EL CAPITAN Anterior Lumbar Interbody Fusion Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: December 20, 2022 Received: December 20, 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. 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. 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 {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 mediation-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 -S Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K222554 #### Device Name EL CAPITAN Anterior Lumbar Interbody Fusion #### Indications for Use (Describe) The EL CAPITAN Anterior Lumbar Interbody Fusion 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 radiographic 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 (6) months of non-operative 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), Oblique interbody devices and EL CAPITAN X must be used with supplemental fixation (e.g. posterior fixation) that has been cleared by the FDA for use in the lumbar spine. The EL CAPITAN X spacer may only be used with titanium alloy screws. Type of Use (Select one or both, as applicable) | | <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. 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}------------------------------------------------ ## 510(k) Summary: EL CAPITAN Anterior Lumbar Interbody Fusion | Date Prepared | August 23, 2022 | |------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitted By | Astura Medical<br>4949 W Royal Ln<br>Irving, TX 75063 | | Contact | Parker Kelch<br>4949 W Royal Ln<br>Irving, TX 75063<br>Phone: 469-501-5530 x503<br>Email: quality@asturamedical.com | | Trade Name | EL CAPITAN Anterior Lumbar Interbody Fusion | | 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<br>Device(s) | Half Dome (K163481, K182877)<br>SIRION (K192006) | | Device Description | The EL CAPITAN Anterior Lumbar Interbody Fusion devices are implants<br>developed for the substitution of the classical autogenous bone graft<br>blocks. The cages assist to avoid complications related to the bone graft<br>donation site (chronic pain, hematoma, infection, bone removal from the<br>donor site making it impossible to remove bone again, quality of the iliac<br>bone, accessing a healthy donor site that may become an unhealthy site,<br>hernias by the incision). The Spacers are a modular design which allows<br>for interchangeable plate and spacer components. The plate and spacer<br>components contain interlocking features in addition to a spring-loaded<br>latch mechanism which allows for intraoperative assembly prior to<br>implantation. The spacer components are available in a range of<br>footprints and heights, and the plates are offered in multiple fixation<br>types and sizes to suit the individual pathology and anatomical conditions<br>of the patient. The implants have a hollow center to allow placement of<br>autogenous bone graft. The superior and inferior surfaces are open to<br>promote contact of the bone graft with the vertebral end plates, allowing<br>bone growth (arthrodesis). | | Materials | Tantalum per ASTM F560<br>Titanium Alloy (Ti6-AL4-V ELI) per ASTM F136<br>Nitinol #1 per ASTM E2063 | | Substantial Equivalence<br>Claimed to Predicate<br>Devices | The EL CAPITAN X device is substantially equivalent to the predicate<br>devices in terms of intended use, design, materials used, mechanical<br>safety and performances. | | Indications for Use | The EL CAPITAN Anterior Lumbar Interbody Fusion 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<br>to be used with autogenous bone graft and supplemental fixation.<br>Patients should have at least six (6) months of non-operative treatment<br>prior to treatment with an intervertebral cage. The EL CAPITAN spacer<br>and plate assembly are an integrated interbody fusion device intended for<br>stand-alone use when used with all titanium alloy screws.<br><br>When used with anchors only the zero plate may be used and the<br>assembly is intended for use with additional supplemental fixation that<br>has been cleared by the FDA for use in the lumbar spine.<br><br>Hyperlordotic interbody devices (>20° lordosis), Oblique interbody devices<br>and EL CAPITAN X must be used with supplemental fixation (e.g. posterior<br>fixation) that has been cleared by the FDA for use in the lumbar spine.<br><br>The EL CAPITAN X spacer may only be used with titanium alloy screws. | | Non-clinical Test<br>Summary | The following analyses were conducted:<br>Static Compression ASTM F2077Dynamic Compression ASTM F2077Static Compression Shear ASTM F2077Dynamic Compression Shear ASTM F2077Subsidence ASTM F2267Expulsion | | | The results of these evaluations indicate that the EL CAPITAN X implants<br>are equivalent to predicate devices. | | Clinical Test Summary | Clinical data were provided as ancillary evidence of substantial<br>equivalence. | | Conclusions: Non-Clinical<br>and Clinical | Astura Medical considers the EL CAPITAN Anterior Lumbar Interbody<br>Fusion 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}------------------------------------------------