DOMINION Expandable Corpectomy System

K233359 · Astura Medical · MQP · Mar 8, 2024 · Orthopedic

Device Facts

• Record ID: K233359
• Device Name: DOMINION Expandable Corpectomy System
• Applicant: Astura Medical
• Product Code: MQP · Orthopedic
• Decision Date: Mar 8, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DOMINION Expandable Corpectomy System is indicated for vertebral body replacement in the cervical spine (C2-T1) and the thoracolumbar spine (T1-L5). The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion. When used in the cervical spine (C2-T1), DOMINION spacers are in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor fracture or osteomyelitis, or for reconstruction following corpectorny performed to achieve decompression of the spinal cord and neural tissues in the cervical degenerative disorders. These spacers are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion. The System is intended to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine. When used in the thoracolumbar spine (T1-L5), DOMINION spacers are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The system is intended to be used with supplemental fixation that has been cleared by the FDA for use in the thoracolumbar spine (i.e. posterior screw and rod systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.

Device Story

Modular spinal implant system; includes expandable columns, modular endplates, and optional screws. Used for anterior column support following vertebral corpectomy. Surgeon inserts and expands column via specialized inserter tools to match patient anatomy; provides mechanical support to spinal column. Used in OR by surgeons. Complements autogenous/allogeneic bone graft to facilitate fusion; provides structural support in tumor cases where fusion may not be achieved. Output is physical stabilization of spinal column.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by non-clinical bench testing, including static/dynamic compression, static/dynamic torsion, expulsion (push-out) testing per ASTM F2077, and subsidence testing per ASTM F2267.

Technological Characteristics

Modular expandable corpectomy spacer. Materials: Titanium Alloy (Ti6-AL4-V ELI) per ASTM F136 and Nitinol (ASTM F2063). Mechanical expansion mechanism. Designed for anterior spinal column support. Non-implantable inserter tools included.

Indications for Use

Indicated for skeletally mature patients requiring vertebral body replacement in cervical (C2-T1) or thoracolumbar (T1-L5) spine. Used for diseased/damaged vertebrae due to tumor, fracture, or osteomyelitis, or reconstruction following corpectomy for decompression. Requires supplemental fixation.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• ALTA Anterior Cervical Corpectomy Spacer (K190426)

Reference Devices

• DOLOMITE Anterior Cervical Stabilization System (K202065)
• FORTIFY Corpectomy Spacer (K173982)
• OLYMPIC Posterior Screw Fixation System (K153446)

Submission Summary (Full Text)

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March 8. 2024

Astura Medical Parker Kelch Quality Manager 4949 West Royal Ln Irving, Texas 75063

Re: K233359

Trade/Device Name: DOMINION Expandable Corpectomy System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: MQP, PLR Dated: February 9, 2024 Received: February 9, 2024

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] 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 Quality Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known) K233359

#### Device Name DOMINION Expandable Corpectomy System

#### Indications for Use (Describe)

The DOMINION Expandable Corpectomy System is indicated for vertebral body replacement in the cervical spine (C2-Tl) and the thoracolumbar spine (T1-L5). The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion.

When used in the cervical spine (C2-T1), DOMINION spacers are in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor fracture or osteomyelitis, or for reconstruction following corpectorny performed to achieve decompression of the spinal cord and neural tissues in the cervical degenerative disorders. These spacers are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion. The System is intended to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine. When used in the thoracolumbar spine (T1-L5), DOMINION spacers are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The system is intended to be used with supplemental fixation that has been cleared by the FDA for use in the thoracolumbar spine (i.e. posterior screw and rod systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.

Type of Use (Select one or both, as applicable)

| <span style="font-family: Arial;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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## 510(k) Summary: DOMINION Expandable Corpectomy System

| Date Prepared | September 29, 2023 |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: [phone] x503<br>Email: [e-mail] |
| Trade Name | DOMINION Expandable Corpectomy System |
| Common Name | Expandable Corpectomy Spacer |
| Classification Name | Spinal Vertebral Body Replacement Device |
| Class | II |
| Product Code | MQP, PLR |
| CFR Section | 21 CFR section 888.3060 |
| Device Panel | Orthopedic |
| Primary Predicate Device | ALTA Anterior Cervical Corpectomy Spacer (K190426) |
| Reference Predicate<br>Device(s) | DOLOMITE Anterior Cervical Stabilization System (K202065)<br>FORTIFY Corpectomy Spacer (K173982)<br>OLYMPIC Posterior Screw Fixation System (K153446) |
| Device Description | The Dominion Expandable Corpectomy system is a modular system<br>comprised of Expandable Columns, Modular Endplates, and optional<br>screws. The primary purpose of the Expandable Column is to provide<br>mechanical support to the anterior column of the spine after a vertebral<br>corpectomy is performed. The primary function of the Modular Endplates<br>is to provide attachment points for the Expandable Column to the<br>vertebral endplates. The screws are an optional device that can provide<br>enhanced fixation to the vertebral endplates when desired. The system<br>contains Inserters which allow the insertion and expansion of the<br>Expandable Columns. |
| Materials | Titanium Alloy (Ti6-AL4-V ELI) per ASTM F136<br>Nitinol #1 (ASTM F2063) |
| Technological<br>characteristics | Compared to the ALTA corpectomy spacer, the Dominion has the<br>capability to expand to the desired height to suit patient anatomy. Once<br>expanded its primary purpose of mechanical support to the anterior<br>column of the spine is equivalent to that of the static ALTA corpectomy<br>spacers. |
| Substantial Equivalence<br>Claimed to Predicate<br>Devices | The DOMINION Expandable Corpectomy 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 DOMINION Expandable Corpectomy System is indicated for vertebral<br>body replacement in the cervical spine (C2-T1) and the thoracolumbar<br>spine (T1-L5). The System is designed for use with autogenous and/or<br>allogeneic bone graft comprised of cancellous and/or corticocancellous<br>bone graft as an adjunct to fusion. |
| | When used in the cervical spine (C2-T1), DOMINION spacers are intended<br>for use in skeletally mature patients to replace a diseased or damaged<br>vertebral body caused by tumor fracture or osteomyelitis, or for<br>reconstruction following corpectomy performed to achieve<br>decompression of the spinal cord and neural tissues in the cervical<br>degenerative disorders. These spacers are intended to restore the<br>integrity of the spinal column even in the absence of fusion for a limited<br>time period in patients with advanced stage tumors involving the cervical<br>spine in whom life expectancy is of insufficient duration to permit<br>achievement of fusion, with bone graft used at the surgeon's discretion.<br>The System is intended to be used with supplemental fixation that has<br>been cleared by the FDA for use in the cervical spine. |
| | When used in the thoracolumbar spine (T1-L5), DOMINION spacers are<br>intended for use to replace a collapsed, damaged, or unstable vertebral<br>body due to tumor or trauma (i.e. fracture). These spacers are designed<br>to provide anterior spinal column support even in the absence of fusion<br>for a prolonged period. |
| | The system is intended to be used with supplemental fixation that has<br>been cleared by the FDA for use in the thoracolumbar spine (i.e. posterior<br>screw and rod systems, anterior plate systems, and anterior screw and<br>rod systems). When used at more than two levels, supplemental fixation<br>should include posterior fixation. |
| Non-clinical Test<br>Summary | The following analyses were conducted:<br>ASTM F2077 - Static compression ASTM F2077 - Dynamic compression ASTM F2077 - Static Torsion ASTM F2077 - Dynamic Torsion Expulsion (Push-Out) |
| Clinical Test Summary | ASTM F2267 - Subsidence No clinical studies were performed |
| Conclusions: Non-Clinical<br>and Clinical | Astura Medical considers the DOMINION Expandable Corpectomy Spacer<br>to be equivalent to the predicate devices listed above. This conclusion is<br>based upon the devices' similarities in principles of operation, technology,<br>materials and indications for use. |

In accordance with 21 CFR 807.92 of the Federal Code of Regulations

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