Fortis and Hana Anterior Cervical Plate System

K173099 · Huvexel Co. , Ltd. · KWQ · Nov 30, 2017 · Orthopedic

Device Facts

• Record ID: K173099
• Device Name: Fortis and Hana Anterior Cervical Plate System
• Applicant: Huvexel Co. , Ltd.
• Product Code: KWQ · Orthopedic
• Decision Date: Nov 30, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FORTIS and HANA Anterior Cervical Plate System is intended for anterior fixation to the cervical spine C2-C7. The specific clinical indications include: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Device Story

System consists of titanium alloy (Ti-6Al-4V ELI) main plates, screws, and pre-assembled lock-plates; used for anterior cervical spine fixation (C2-C7). Plates available in various lengths for one-to-four level procedures; screws available in fixed/variable self-tapping and self-drilling configurations. Components color-anodized for identification. Surgeon implants device during spinal surgery to provide stabilization; lock-plate prevents screw back-out. Device provides mechanical support to facilitate fusion; benefits patient by stabilizing cervical spine segments.

Clinical Evidence

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

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136. Components: Main plates, screws, pre-assembled lock-plates. Features: Color-anodized components, fixed/variable self-tapping and self-drilling screws. Supplied non-sterile, single-use. Mechanical testing per ASTM F1717.

Indications for Use

Indicated for anterior fixation to the cervical spine C2-C7 in patients with degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, spinal deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion.

Regulatory Classification

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.

Predicate Devices

• Huvexel - Rex Anterior Cervical Plate System (K121862)
• Globus Medical – VIP Anterior Cervical Plate System (K081391)
• Synthes Spine - Synthes Anterior CSLP System (K000742)
• EBI - EBI Anterior Cervical Plate System (K001794)
• Aesculap – Aesculap ABC Cervical Plating System (K974706)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 30, 2017

Huvexel Co., Ltd % Milan George Senior R&D Director Dio Medical Corporation 8770 W Bryn Mawr Ave. Ste. 1250 Chicago, Illinois 60631

Re: K173099

Trade/Device Name: Fortis and Hana Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: September 28, 2017 Received: September 29, 2017

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. 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

{1}------------------------------------------------

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.

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

## Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation 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: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

Device Name

Fortis and Hana Anterior Cervical Plate System

Indications for Use (Describe)

Fortis and Hana Anterior Cervical Plate System is intended for anterior fixation to the cervical spine C2-C7. The specific clinical indications include:

degenerative disc disease (DD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

| Type of Use (Select one or both, as applicable) | <table><tr><td><div> <span> <span style="text-decoration: underline;"></span>Prescription Use (Part 21 CFR 801 Subpart D) </span> </div></td><td><div> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div></td></tr></table> | <div> <span> <span style="text-decoration: underline;"></span>Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |
|-------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: underline;"></span>Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | | |

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

[e-mail]

"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."

FORM FDA 3881 (7/17)

{3}------------------------------------------------

## 510(k) SUMMARY

## HUVEXEL Co., Ltd's FORTIS and HANA Anterior Cervical Plate System

| Sponsor: | Manufacturer: | HUVEXEL Co., Ltd.<br>101-105 Megacenter, SK Technopark<br>124 Sagimakgol-ro, Jungwon-gu Seongnam-si<br>Gyeonggi-do, South Korea |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| | Official Contact: | Milan George<br>[e-mail]<br>267-737-9496 x102<br>847-795-1079 |
| Date Prepared: | | November 30, 2017 |
| Device Name: | FORTIS and HANA Anterior Cervical Plate System | |
| Common Name: | Anterior Cervical Plate System | |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis | |
| Classification<br>Number: | 21 CFR 888.3060 | |
| Product<br>Code/Classification: | KWQ, class II | |
| Description: | The FORTIS and HANA Anterior Cervical Plate System consists of a variety of<br>shapes and sizes of Main Plates, screw, lock-plate and the associated<br>instruments. The lock-plate is pre-assembled to the main plate and<br>designed to prevent screws from backing out. Each component is subjected<br>to a color anodizing process to differentiate the screw type and diameter<br>and to make the surgical process easy. The plates range in length to<br>accommodate one and two-level procedures for HANA and one, two, three,<br>and four level procedures for FORTIS. Main plate is available from 13mm to<br>46mm for HANA and 10mm to 112mm for FORTIS. Screws are available in<br>lengths from 12mm to 20mm for HANA and 10mm to 20mm in 2mm<br>increments for FORTIS. The screws have either a 4.5mm or 5.1mm diameter<br>for HANA and 4.0mm or 4.5mm diameter for FORTIS. They are fixed self-<br>tapping, variable self-tapping screw, fixed self-drilling screw, variable self-<br>drilling.<br>The FORTIS and HANA Anterior Cervical Plate System components are<br>supplied non-sterile, are single use and are fabricated from titanium allow<br>(Ti-6Al-4V ELI) that conforms to ASTM F136. | |
| Intended Use: | The FORTIS and HANA Anterior Cervical Plate System is intended for<br>anterior fixation to the cervical spine C2-C7. The specific clinical indications<br>include: | |
| | degenerative disc disease (DDD) (defined as neck pain of discogenic origin<br>with degeneration of the disc confirmed by history and radiographic<br>studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal<br>stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),<br>tumor, pseudoarthrosis, and failed previous fusion. | |
| Performance Data: | Mechanical testing (Static compression bending, Dynamic compression<br>bending, and Static torsion test) in accordance with the ASTM 1717 was<br>performed. | |
| Predicate Device: | Primary predicate: Huvexel - Rex Anterior Cervical Plate System (K121862)<br>Additional predicate: Globus Medical – VIP Anterior Cervical Plate System<br>(K081391), Synthes Spine - Synthes Anterior CSLP System (K000742), EBI -<br>EBI Anterior Cervical Plate System (K001794) and Aesculap – Aesculap ABC<br>Cervical Plating System (K974706) | |
| Performance and SE<br>Determination: | The FORTIS and HANA Anterior Cervical Plate System has been<br>demonstrated to be substantially equivalent to the predicate system(s) with<br>respect to technical characteristics, performance, and intended use. The<br>information provided within this premarket notification supports<br>substantial equivalence of the subject device to the predicate device(s). | |

{4}------------------------------------------------