FaSet Fixation System

K180729 · Huvexel Co. , Ltd. · MRW · Jun 28, 2018 · OR

Device Facts

• Record ID: K180729
• Device Name: FaSet Fixation System
• Applicant: Huvexel Co. , Ltd.
• Product Code: MRW · OR
• Decision Date: Jun 28, 2018
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• 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/titanium alloy (Ti-6Al-4V ELI) screws; used for bilateral immobilization of facet joints to aid spinal fusion. Implants are inserted posteriorly by surgeons in an OR setting; transfacet or translaminar approach; screws traverse facet joint into pedicle. Provides mechanical support and stability to the spinal level until biologic fusion occurs. Various sizes/lengths available to accommodate patient anatomy.

Clinical Evidence

Bench testing only. Mechanical testing including static compression bending, dynamic compression bending, and static torsion tests performed in accordance with ASTM F1717.

Technological Characteristics

Materials: Titanium or titanium alloy (Ti-6Al-4V ELI) per ASTM F67 and F136. Mechanical support via screw fixation. Various sizes and lengths available. Non-active, implantable device.

Indications for Use

Indicated for patients requiring posterior spinal fusion (C2-S1) for spondylolisthesis, pseudoarthrosis, failed previous fusions, spondylolysis, degenerative disc disease with instability, or trauma (fractures/dislocations).

Predicate Devices

• Nexxt Spine - Facet Fixx (K131417)
• Globus Medical Inc. – Corridor Fixation System (K083442)
• Medtronic - UCSS/Townley Transfacetpedicular Screw Fixation System (K953076, K003928, K013829)
• X-Spine Systems - Zygafix Spinal Facet Screw System (K123932)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| | <span style="white-space: nowrap;"><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</span> |
| | <span style="white-space: nowrap;"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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# 510(k) SUMMARY

## HUVEXEL Co., Ltd's FaSet Fixation System

| Sponsor: | |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | HUVEXEL Co., Ltd.<br>101-105 Megacenter, SKn Technopark<br>124 Sagimakgol-ro, Jungwon-gu<br>Seongnam-si<br>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<br>manufactured from titanium or titanium alloy (Ti-6Al-4V ELI) as<br>specified in ASTM F67, and F136. Various sizes and lengths of<br>these implants are available to accommodate patient anatomy.<br>The device is intended to provide mechanical support and stability<br>to the implanted level until biologic fusion is achieved. |
| Intended Use: | The FaSet Fixation System is intended to stabilize the spine as an<br>aid to fusion through bilateral immobilization of facet joints. The<br>Facet Screw System is indicated for posterior surgical treatment<br>with or without bone graft at single or multiple levels from C2 to<br>S1 (inclusive). For transfacet fixation, the screws are inserted<br>posteriorly through the superior side of the facet, across the facet<br>joint, and into the pedicle. For translaminar facet fixation, the<br>screws are inserted posteriorly through the lateral aspect of the<br>spinous process, through the lamina, through the superior side of<br>the facet, across the facet joint, and into the pedicle. The FaSet |

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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).