(47 days)
The FaSet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of facet joints. The Facet Screw System is indicated for posterior surgical treatment with or without bone graft at single or multiple levels from C2 to S1 (inclusive). For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet joint, and into the pedicle. The FaSet Fixation System is indicated for treatment for any or all of the following:
- Spondylolisthesis
- Pseudoarthrosis or failed previous fusions which are symptomatic, or which may cause secondary instability or deformity
- Spondylolysis
- Degenerative Disk Disease (DDD) as defined by back pain of discogenic origin with degeneration of disk confirmed by history and radiographic studies and/or degenerative disease of the facets with instability
- Trauma including spinal fractures and/or dislocations.
The FaSet Fixation System consist of permanent implant devices manufactured from titanium or titanium alloy (Ti-6Al-4V ELI) as specified in ASTM F67, and F136. Various sizes and lengths of these implants are available to accommodate patient anatomy. The device is intended to provide mechanical support and stability to the implanted level until biologic fusion is achieved.
This document is a 510(k) summary for the Dio Medical FaSet Fixation System, which is a medical device for spinal stabilization. The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it's as safe and effective.
Based on the provided text, no study was conducted to prove the device meets acceptance criteria. The key statement is found under "Performance Data" in the 510(k) Summary:
"The subject and predicate devices are identical and therefore, no performance testing is required. Submission is only transferring name of a system that has already been cleared under K180729. No testing is required."
This means that instead of conducting new performance studies, Dio Medical Corporation is asserting that their "FaSet Fixation System" is identical to a previously cleared device (Huvexel Co. Ltd. - FaSet Fixation System, K180729). Therefore, the device's acceptance criteria and the study proving it meets them would be found in the documentation for the predicate device (K180729), not in this specific submission (K222515).
Since the document explicitly states "No testing is required," I cannot provide answers to the questions you posed regarding acceptance criteria, reported performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment based on this FDA 510(k) summary for K222515. The information you're requesting would have been part of the original K180729 submission made by Huvexel Co. Ltd.
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October 5, 2022
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Dio Medical Corporation Milan George Vice President of R&D 2100 Campus Lane, Suite 100 East Norriton, Pennsylvania 19403
Re: K222515
Trade/Device Name: FaSet Fixation System Regulatory Class: Unclassified Product Code: MRW Dated: August 18, 2022 Received: August 19, 2022
Dear Milan George:
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 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-reporting
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combination-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Colin O'Neill, M.B.E. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K222515
Device Name FaSet Fixation System
Indications for Use (Describe)
The FaSet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of facet joints. The Facet Screw System is indicated for posterior surgical treatment with or without bone graft at single or multiple levels from C2 to S1 (inclusive). For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet joint, and into the pedicle. The FaSet Fixation System is indicated for treatment for any or all of the following:
- Spondylolisthesis -
- Pseudoarthrosis or failed previous fusions which are symptomatic, or which may cause secondary । instability or deformity
- Spondylolysis
- Degenerative Disk Disease (DDD) as defined by back pain of discogenic origin with degeneration of disk confirmed by history and radiographic studies and/or degenerative disease of the facets with instability
- Trauma including spinal fractures and/or dislocations.
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)
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510(k) SUMMARY
Dio Medical FaSet Fixation System
| Sponsor: | Manufacturer: | Dio Medical Corp.2100 Campus Lane, Suite 100East Norriton, PA 19403 |
|---|---|---|
| Official Contact: | Milan George | |
| Email: | mgeorge@dio-us.com | |
| Phone: | 1-877-394-5407 ext.102 | |
| Date Prepared: | August 18, 2022 | |
| Device Name: | FaSet Fixation System | |
| Common Name: | System, Facet Screw Spinal Device | |
| Classification Name: | Unclassified | |
| Classification Number: | N/A | |
| Product Code/Classification: | MRW, Unclassified | |
| Description: | The FaSet Fixation System consist of permanent implant devicesmanufactured from titanium or titanium alloy (Ti-6Al-4V ELI) asspecified in ASTM F67, and F136. Various sizes and lengths of theseimplants are available to accommodate patient anatomy. Thedevice is intended to provide mechanical support and stability tothe implanted level until biologic fusion is achieved. | |
| Intended Use: | The FaSet Fixation System is intended to stabilize the spine as anaid to fusion through bilateral immobilization of facet joints. TheFacet Screw System is indicated for posterior surgical treatmentwith or without bone graft at single or multiple levels from C2 to S1(inclusive). For transfacet fixation, the screws are insertedposteriorly through the superior side of the facet, across the facetjoint, and into the pedicle. For translaminar facet fixation, thescrews are inserted posteriorly through the lateral aspect of thespinous process, through the lamina, through the superior side ofthe facet, across the facet joint, and into the pedicle. The FaSetFixation System is indicated for treatment for any or all of thefollowing: | |
| - Spondylolisthesis- Pseudoarthrosis or failed previous fusions which aresymptomatic, or which may cause secondary instability ordeformity- Spondylolysis- Degenerative Disk Disease (DDD) as defined by back pain ofdiscogenic origin with degeneration of disk confirmed by historyand radiographic studies and/or degenerative disease of thefacets with instability- Trauma including spinal fractures and/or dislocations. | ||
| PredicateDevice: | Primary predicate:Huvexel Co. Ltd. - FaSet Fixation System (K180729) | |
| SubstantialEquivalence: | The FaSet Fixation System is identical to the predicate device and isas safe and effective as the Huvexel - FaSet Fixation System. TheSubject device has the same intended uses and similar indications,technological characteristics, and principles of operation as itspredicate device. There are no technological differences betweenthe Subject device and its predicate devices resulting in no newissues of safety or effectiveness. Thus, the Dio Medical- FaSetFixation System is identical/substantially equivalent to thepredicates. | |
| PerformanceData: | The subject and predicate devices are identical and therefore, noperformance testing is required. Submission is only transferringname of a system that has already been cleared under K180729.No testing is required. | |
| Conclusion: | The Dio Medical FaSet Fixation System has the same intended usesand similar indications, technological characteristics, and principlesof operation as its predicate device. Thus, the subject device isidentical/substantially equivalent to the predicate device. |
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N/A