DOLOMITE Anterior Cervical Stabilization System

K202065 · Astura Medical, LLC · OVE · Oct 26, 2020 · Orthopedic

Device Facts

• Record ID: K202065
• Device Name: DOLOMITE Anterior Cervical Stabilization System
• Applicant: Astura Medical, LLC
• Product Code: OVE · Orthopedic
• Decision Date: Oct 26, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

DOLOMITE Anterior Cervical Stabilization System; modular 2-piece interbody fusion device; consists of interchangeable spacer and plate components. Spacers available in PEEK-OPTIMA LT120HA or titanium alloy; plates in titanium alloy. Features interlocking design and locking mechanism for intraoperative assembly. Hollow center accommodates bone graft; open superior/inferior surfaces facilitate fusion. Used by surgeons in clinical settings for cervical stabilization; provides structural support and fixation at one or two levels. Implanted via anterior approach; stabilizes cervical column; promotes bone growth across vertebral endplates. Benefits patients by addressing discogenic pain through fusion.

Clinical Evidence

No clinical studies were performed. Equivalence established via non-clinical bench testing including dynamic and static compression and torsion testing.

Technological Characteristics

Modular 2-piece interbody spacer and plate system. Materials: PEEK-OPTIMA LT120HA, Tantalum (ASTM F560), Titanium alloy (Ti-6Al-4V ELI, ASTM F136), Nitinol (ASTM F2063). Mechanical fixation via integrated locking mechanism and titanium alloy screws. Standalone or supplemental fixation configurations.

Indications for Use

Indicated for intervertebral body fusion in skeletally mature patients with cervical DDD (C2-T1) presenting with discogenic neck pain confirmed by history/radiography. Requires 6 weeks prior nonoperative treatment. Used with autogenous/allogeneic bone graft.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• Astura Medical ALTA Anterior Cervical Interbody Spacer (K160154)
• Globus COALITION Spacer (K173115)
• Globus HEDRON Cervical Spacer (K191243)
• LDR Spine Cervical Interbody Fusion System (K091088)

Submission Summary (Full Text)

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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. 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

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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 (QS) 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 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 ([e-mail]) or phone [phone] 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

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# 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> |

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## 510(k) Summary

| Date Prepared | June 26, 2020 |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By | Astura Medical<br>4949 W Royal Ln<br>Irving, TX 75063<br>Phone: [phone] |
| Contact | Parker Kelch<br>Email: [e-mail] |
| 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. |

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