← Product Code MRW · K222515 # FaSet Fixation System (K222515) _Dio Medical Corporation · MRW · Oct 5, 2022 · OR · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K222515 ## Device Facts - **Applicant:** Dio Medical Corporation - **Product Code:** MRW - **Decision Date:** Oct 5, 2022 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** OR - **Attributes:** Therapeutic ## Intended Use 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, across 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, across 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. ## Device Story FaSet Fixation System consists of permanent titanium or titanium alloy (Ti-6Al-4V ELI) spinal implants; provides mechanical support and stability to implanted levels until biologic fusion occurs. Used in posterior surgical procedures; screws inserted via transfacet or translaminar approach into pedicle. System accommodates various patient anatomies through multiple screw sizes/lengths. Device is identical to previously cleared predicate (K180729). ## Clinical Evidence No clinical data; device is identical to the predicate device (K180729). ## Technological Characteristics Permanent spinal implants manufactured from titanium or titanium alloy (Ti-6Al-4V ELI) per ASTM F67 and F136. Mechanical fixation device; no software or energy source. ## Predicate Devices - Huvexel Co. Ltd. - FaSet Fixation System ([K180729](/device/K180729.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ October 5, 2022 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health and Human Services logo, which features an abstract image of a human figure. To the right of this is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue font. The word "FDA" is in a larger, bolder font than the rest of the text. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ### 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) ### 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 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 aqency 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." FORM FDA 3881 (6/20) {3}------------------------------------------------ # 510(k) SUMMARY # Dio Medical FaSet Fixation System | Sponsor: | Manufacturer: | Dio Medical Corp.
2100 Campus Lane, Suite 100
East 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 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. | | | Intended Use: | 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, across 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, across 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. | | | Predicate
Device: | Primary predicate:
Huvexel Co. Ltd. - FaSet Fixation System (K180729) | | | Substantial
Equivalence: | The FaSet Fixation System is identical to the predicate device and is
as safe and effective as the Huvexel - FaSet Fixation System. The
Subject device has the same intended uses and similar indications,
technological characteristics, and principles of operation as its
predicate device. There are no technological differences between
the Subject device and its predicate devices resulting in no new
issues of safety or effectiveness. Thus, the Dio Medical- FaSet
Fixation System is identical/substantially equivalent to the
predicates. | | | Performance
Data: | 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. | | | Conclusion: | The Dio Medical FaSet Fixation System has the same intended uses
and similar indications, technological characteristics, and principles
of operation as its predicate device. Thus, the subject device is
identical/substantially equivalent to the predicate device. | | {4}------------------------------------------------ --- **Source:** [https://fda.innolitics.com/device/K222515](https://fda.innolitics.com/device/K222515) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com