(161 days)
No
The 510(k) summary describes a mechanical implant for spinal surgery and does not mention any software, algorithms, or AI/ML capabilities.
Yes
Explanation: The device is implanted to replace diseased, damaged, or unstable vertebral bodies, providing structural support and aiding in spinal column integrity, which directly addresses a medical condition.
No
The device description clearly states its purpose is to provide mechanical support to the anterior column of the spine following corpectomy, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines physical components like Expandable Columns, Modular Endplates, screws, and Inserters, indicating it is a hardware-based medical device for surgical implantation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The DOMINION Expandable Corpectomy System is a surgical implant designed to replace damaged vertebral bodies in the spine. It is a physical device used within the body during surgery, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes. Its function is purely structural support and reconstruction.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MQP, PLR
Device Description
The Dominion Expandable Corpectomy system is a modular system comprised of Expandable Columns, Modular Endplates, and optional screws. The primary purpose of the Expandable Column is to provide mechanical support to the anterior column of the spine after a vertebral corpectomy is performed. The primary function of the Modular Endplates is to provide attachment points for the Expandable Column to the vertebral endplates. The screws are an optional device that can provide enhanced fixation to the vertebral endplates when desired. The system contains Inserters which allow the insertion and expansion of the Expandable Columns.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-Tl) and the thoracolumbar spine (T1-L5)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical test summary:
The following analyses were conducted:
ASTM F2077 - Static compression
ASTM F2077 - Dynamic compression
ASTM F2077 - Static Torsion
ASTM F2077 - Dynamic Torsion
Expulsion (Push-Out)
ASTM F2267 - Subsidence
Clinical Test Summary:
No clinical studies were performed
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ALTA Anterior Cervical Corpectomy Spacer (K190426)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
DOLOMITE Anterior Cervical Stabilization System (K202065), FORTIFY Corpectomy Spacer (K173982), OLYMPIC Posterior Screw Fixation System (K153446)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it. The full name reads "U.S. Food & Drug Administration".
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).
1
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 (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 Quality Center for Devices and Radiological Health
2
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------- | ----------------------------------------------- |
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: DOMINION Expandable Corpectomy System
| Date Prepared | September 29, 2023 |
|---|---|
| Submitted By | Astura Medical |
| 4949 W Royal Ln | |
| Irving, TX 75063 | |
| Contact | Parker Kelch |
| 4949 W Royal Ln | |
| Irving, TX 75063 | |
| Phone: 469-501-5530 x503 | |
| Email: parker@asturamedical.com | |
| 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 | |
| Device(s) | DOLOMITE Anterior Cervical Stabilization System (K202065) |
| FORTIFY Corpectomy Spacer (K173982) | |
| OLYMPIC Posterior Screw Fixation System (K153446) | |
| Device Description | The Dominion Expandable Corpectomy system is a modular system |
| comprised of Expandable Columns, Modular Endplates, and optional | |
| screws. The primary purpose of the Expandable Column is to provide | |
| mechanical support to the anterior column of the spine after a vertebral | |
| corpectomy is performed. The primary function of the Modular Endplates | |
| is to provide attachment points for the Expandable Column to the | |
| vertebral endplates. The screws are an optional device that can provide | |
| enhanced fixation to the vertebral endplates when desired. The system | |
| contains Inserters which allow the insertion and expansion of the | |
| Expandable Columns. | |
| Materials | Titanium Alloy (Ti6-AL4-V ELI) per ASTM F136 |
| Nitinol #1 (ASTM F2063) | |
| Technological | |
| characteristics | Compared to the ALTA corpectomy spacer, the Dominion has the |
| capability to expand to the desired height to suit patient anatomy. Once | |
| expanded its primary purpose of mechanical support to the anterior | |
| column of the spine is equivalent to that of the static ALTA corpectomy | |
| spacers. | |
| Substantial Equivalence | |
| Claimed to Predicate | |
| Devices | The DOMINION Expandable Corpectomy System is substantially |
| equivalent to the predicate devices in terms of intended use, design, | |
| materials used, mechanical safety and performances. | |
| Indications for 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 intended | |
| for use in skeletally mature patients to replace a diseased or damaged | |
| vertebral body caused by tumor fracture or osteomyelitis, or for | |
| reconstruction following corpectomy 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, anterior plate systems, and anterior screw and | |
| rod systems). When used at more than two levels, supplemental fixation | |
| should include posterior fixation. | |
| Non-clinical Test | |
| Summary | The following analyses were conducted: |
| 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 | |
| and Clinical | Astura Medical considers the DOMINION Expandable Corpectomy Spacer |
| to be equivalent to the predicate devices listed above. This conclusion is | |
| based upon the devices' similarities in principles of operation, technology, | |
| materials and indications for use. |
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
4