DOLOMITE Anterior Cervical Stabilization System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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. October 26, 2020 Astura Medical, LLC Mr. Parker Kelch Quality Manager 4949 W Royal Ln. Irving, Texas 75063 Re: K202065 Trade/Device Name: DOLOMITE Anterior Cervical Stabilization System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE, ODP Dated: July 23, 2020 Received: July 27, 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). 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, 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) #### K202065 Device Name DOLOMITE Anterior Cervical Stabilization System #### Indications for Use (Describe) The DOLOMITE Stand-Alone Cervical Interbody Spacer is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at disc levels (C2-T1). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should have at least six weeks of nonoperative treatment with intervertebral cages. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The Dolomite Spacer is an interbody fusion device intended to be used with supplemental fixation for one or two levels of the cervical spine. The DOLOMITE Spacer and Plate assembly are an integrated interbody fusion device intended for stand-alone use at one or two levels of the cervical spine (C2-T1) and used with titanium alloy screws. Multiple full plate assembly configurations can't be used in conjunction for two contiguous levels of the cervical spine. When used with anchors, the assembly is intended for use at one level of the cervical spine with additional supplemental fixation that has been cleared by the FDA for use in the cervical spine. | Type of Use ( <i>Select one or both, as applicable</i> ) | |-----------------------------------------------------------------------------------------------------------| | <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | | <span> <span style="font-size: 16px;">☐</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 information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary | Date Prepared | June 26, 2020 | |------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitted By | Astura Medical<br>4949 W Royal Ln<br>Irving, TX 75063<br>Phone: 469-501-5530 | | Contact | Parker Kelch<br>Email: quality@asturamedical.com | | Trade Name | DOLOMITE Anterior Cervical Stabilization System | | Common Name | Intervertebral body fusion device | | Classification Name | Intervertebral body fusion device - cervical | | Class | II | | Product Code | OVE, ODP | | CFR Section | 21 CFR section 888.3080 | | Device Panel | Orthopedic | | Primary Predicate<br>Device | Astura Medical ALTA Anterior Cervical Interbody Spacer (K160154) | | Secondary Predicate<br>Device | Globus COALITION Spacer (K173115); Globus HEDRON Cervical Spacer<br>(K191243); LDR Spine Cervical Interbody Fusion System (K091088) | | Device Description | The DOLOMITE Anterior Cervical Stabilization System are implants developed<br>for the stabilization of the cervical column. The spacers are a 2-piece modular<br>design which allows for interchangeable plate and spacer components. The<br>plate and spacer components contain interlocking features in addition to a<br>locking mechanism which allows for intraoperative assembly prior to<br>implantation. The spacer components are available in a range of footprints and<br>heights in PEEK OPTIMA LT120HA or machined Titanium alloy. The plates are<br>offered in multiple fixation types and sizes to suit the individual pathology and<br>anatomical conditions of the patient in machined Titanium alloy. The implants<br>have a hollow center to allow placement of autogenous bone graft. The<br>superior and inferior surfaces are open to promote contact of the bone graft<br>with the vertebral end plates to allow bone growth. | | Materials | PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced)<br>Tantalum per ASTM F560<br>Titanium alloy (Ti-6Al-4V ELI) per ASTM F136<br>Nitinol #1 (ASTM F2063) | | Substantial<br>Equivalence Claimed<br>to Predicate Devices | The DOLOMITE Stand-Alone Cervical System is substantially equivalent to the<br>predicate devices in terms of intended use, design, materials<br>used, mechanical safety and performance. | | Indications for Use | The DOLOMITE Stand-Alone Cervical Interbody Spacer is indicated for<br>intervertebral body fusion procedures in skeletally mature patients with<br>degenerative disc disease (DDD) of the cervical spine at disc levels (C2-T1).<br>Cervical degenerative disc disease is defined as neck pain of discogenic origin<br>with degeneration of the disc confirmed by history and radiographic studies.<br>Patients should have at least six weeks of nonoperative treatment prior to<br>treatment with intervertebral cages. The System is designed for use with<br>autogenous and/or allogeneic bone graft comprised of cancellous and/or<br>corticocancellous bone graft to facilitate fusion. | | | | | | The Dolomite Spacer is an interbody fusion device intended to be used with<br>supplemental fixation for one or two levels of the cervical spine.<br><br>The DOLOMITE Spacer and Plate assembly are an integrated interbody fusion<br>device intended for stand-alone use at one or two levels of the cervical spine<br>(C2-T1) and used with titanium alloy screws. Multiple full plate assembly<br>configurations can't be used in conjunction for two contiguous levels of the<br>cervical spine. When used with anchors, the assembly is intended for use at<br>one level of the cervical spine with additional supplemental fixation that has<br>been cleared by the FDA for use in the cervical spine. | | Non-clinical Test<br>Summary | The following analyses were conducted:<br>Dynamic Compression Static Compression Dynamic Torsion Static Torsion The results of these evaluations indicate that the Dolomite implants<br>are equivalent to predicate devices. | | Clinical Test<br>Summary | No clinical studies were performed | | Conclusions: Non-<br>Clinical and Clinical | Astura Medical considers DOLOMITE Anterior Cervical Stabilization System to<br>be equivalent to the predicate devices listed above. This conclusion is based<br>upon the devices' similarities in principles of operation, technology, materials<br>and indications for use. | {4}------------------------------------------------