(100 days)
Not Found
No
The device description and performance studies focus on mechanical properties and materials, with no mention of AI/ML or related concepts like image processing, training data, or performance metrics typically associated with AI/ML devices.
Yes
The device is described as a permanent implant system intended to stabilize the spine and aid in fusion, which clearly aligns with the definition of a therapeutic device designed to treat specific medical conditions.
No
This product is a fixation system intended to stabilize the spine and aid in fusion, not to diagnose medical conditions.
No
The device description explicitly states it consists of "permanent implant devices manufactured from titanium or titanium alloy," indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The FaSet Fixation System is described as a permanent implant device made of titanium or titanium alloy. It is intended to provide mechanical support and stability to the spine.
- Intended Use: The intended use is to stabilize the spine as an aid to fusion through bilateral immobilization of facet joints, for posterior surgical treatment. This is a surgical implant, not a device used to test specimens from the body.
The information provided clearly indicates that this is a surgical implant used directly in the body for structural support, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The FaSet Fixation System is intended to spine as an aid to fusion through bilateral immobilization of facet joints. The FaSet Screw Systems 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 posterior 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 superior side of the facet, across the facet joint, and into the pedicle. The FaSet Fixation System is indicated 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 Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability Trauma including spinal fractures and/or dislocations
Product codes
MRW
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C2 to S1 (inclusive)
Indicated Patient Age Range
Not Found
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
Mechanical testing (Static compression bending, Dynamic compression bending, and Static torsion test) in accordance with the ASTM 1717 was performed.
Key Metrics
Not Found
Predicate Device(s)
K131417, K083442, K953076, K003928, K013829, K123932
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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June 28, 2018
Huvexel Co., Ltd % Mr. Milan George Vice President, Research & Development Dio Medical Corporation 8770 West Bryn Mawr Avenue, Suite 1250 Chicago, Illinois 60631
Re: K180729
Trade/Device Name: FaSet Fixation System Regulatory Class: Unclassified Product Code: MRW Dated: June 25, 2018 Received: June 27, 2018
Dear Mr. 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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180729
Device Name FaSet Fixation System
Indications for Use (Describe)
The FaSet Fixation System is intended to spine as an aid to fusion through bilateral immobilization of facet joints. The FaSet Screw Systems 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 posterior 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 superior side of the facet, across the facet joint, and into the pedicle. The FaSet Fixation System is indicated 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 Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of disc 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
HUVEXEL Co., Ltd's FaSet Fixation System
| Sponsor: | |
|---|---|
| Manufacturer | HUVEXEL Co., Ltd. |
| 101-105 Megacenter, SKn Technopark | |
| 124 Sagimakgol-ro, Jungwon-gu | |
| Seongnam-si | |
| Gyeonggi-do, South Korea | |
| Official Contact | Milan George |
| Phone: | 267-737-9496 x102 |
| Fax: | 847-795-1079 |
| Date: | March 19, 2018 |
| 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 |
4
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. -Performance Data: Mechanical testing (Static compression bending, Dynamic compression bending, and Static torsion test) in accordance with the ASTM 1717 was performed. Predicate Device: Primary predicate: Nexxt Spine - Facet Fixx (K131417) Additional predicates: Globus Medical Inc. – Corridor Fixation System (K083442), Medtronic - UCSS/Townley Transfacetpedicular Screw Fixation System (K953076, K003928, K013829), and X-Spine Systems - Zygafix Spinal Facet Screw System (K123932) Performance and The FaSet Fixation System have been demonstrated to be SE Determination: substantially equivalent to the predicate system(s) with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject device to the predicate device(s).