EL CAPITAN Anterior Lumber Interbody System

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April 21, 2020 Astura Medical, LLC Mr. Parker Kelch Quality Manager 3186 Lionshead Ave, Suite 100 Carlsbad, California 92010 Re: K192492 Trade/Device Name: EL CAPITAN Anterior Lumber Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: April 10, 2020 Received: April 13, 2020 Dear Mr. 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). 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Sincerely, Brent Showalter, Ph.D. Acting 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) ## K192492 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 skeletally 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 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 anchors, 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) 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><span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span></td><td><span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span></td></tr></table> | <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> | | <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </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* 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 In accordance with 21 CFR 807.92 of the Federal Code of Regulations | Date Prepared | April 10, 2020 | |------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitted By | Astura Medical<br>3186 Lionshead Ave, Suite 100<br>Carlsbad, CA 92010<br>Phone: 760-814-8047 | | Contact | Parker Kelch<br>3186 Lionshead Ave, Suite 100<br>Carlsbad, CA 92010<br>Phone: 760-814-8047 x413<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 | HALF DOME Posterior Lumbar Interbody System (K152512) | | Additional Predicate Device(s) | Half Dome (K163481, K172947, K182877)<br>Biomet Fusion System (K141791, K163543)<br>Medtronic Pyramid Fixation System (K013665)<br>NuVasive BASE Interfixated System (K170592)<br>Stryker AVS (K143163)<br>Core-Link M3 (K180814) | | Device Description | The EL CAPITAN Anterior Lumbar Interbody 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 2-piece modular design which<br>allows for interchangeable plate and spacer components. The plate and<br>spacer components contain interlocking features in addition to a spring-<br>loaded 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 | PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced) – MAF 2227<br>Tantalum per ASTM F560<br>Titanium Alloy (Ti6-AL4-V ELI) per ASTM F136<br>Nitinol #1 (ASTM F2063) | | 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<br>spondylolisthesis or retrolisthesis at the involved level(s). EL CAPITAN<br>System implants are to be used with autogenous bone graft and<br>supplemental fixation. Patients should have at least six (6) months of<br>non-operative treatment prior to treatment with an intervertebral cage.<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, the assembly is intended for use<br>with additional supplemental fixation that has been cleared by the FDA<br>for use in the lumbar spine.<br>Hyperlordotic interbody devices (>20° lordosis) must be used with<br>supplemental fixation (e.g. posterior fixation) that has been cleared by<br>the FDA for use in the Lumbar spine. | | Non-clinical Test<br>Summary | The following analyses were conducted:<br>• Static Compression ASTM F2077<br>• Dynamic Compression ASTM F1717<br>• Static Compression Shear ASTM F2077<br>• Dynamic Compression Shear ASTM F1717<br>• Subsidence ASTM F2267<br>• Expulsion<br>The results of these evaluations indicate that the EL CAPITAN implants<br>are 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. | {4}------------------------------------------------