(62 days)
No
The device description focuses on the physical components and materials of a cervical plate system, with no mention of software, algorithms, or AI/ML capabilities.
No.
A therapeutic device is typically understood to deliver a therapy or treatment directly. This device is an implant for fixation, which aids in healing and stability but does not actively deliver a therapeutic agent or energy.
No
Explanation: The device is an anterior cervical plate system used for surgical fixation of the spine, not for diagnosing medical conditions.
No
The device description clearly states it consists of physical components like plates, screws, and instruments made from titanium alloy, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "anterior fixation to the cervical spine C2-C7" to treat various spinal conditions. This is a surgical implant used in vivo (within the body).
- Device Description: The description details physical components like plates, screws, and instruments made of titanium alloy. These are surgical hardware, not reagents, instruments, or software used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), performing tests on samples, or providing diagnostic information based on laboratory analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to stabilize the spine.
N/A
Intended Use / Indications for Use
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.
Product codes
KWQ
Device Description
The FORTIS and HANA Anterior Cervical Plate System consists of a variety of shapes and sizes of Main Plates, screw, lock-plate and the associated instruments. The lock-plate is pre-assembled to the main plate and designed to prevent screws from backing out. Each component is subjected to a color anodizing process to differentiate the screw type and diameter and to make the surgical process easy. The plates range in length to accommodate one and two-level procedures for HANA and one, two, three, and four level procedures for FORTIS. Main plate is available from 13mm to 46mm for HANA and 10mm to 112mm for FORTIS. Screws are available in lengths from 12mm to 20mm for HANA and 10mm to 20mm in 2mm increments for FORTIS. The screws have either a 4.5mm or 5.1mm diameter for HANA and 4.0mm or 4.5mm diameter for FORTIS. They are fixed self-tapping, variable self-tapping screw, fixed self-drilling screw, variable self-drilling. The FORTIS and HANA Anterior Cervical Plate System components are supplied non-sterile, are single use and are fabricated from titanium allow (Ti-6Al-4V ELI) that conforms to ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine C2-C7
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing (Static compression bending, Dynamic compression bending, and Static torsion test) in accordance with the ASTM 1717 was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K121862, K081391, K000742, K001794, K974706
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
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.(b)
Classification. Class II.
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
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
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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: 06/30/2020 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) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (7/17)
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510(k) SUMMARY
HUVEXEL Co., Ltd's FORTIS and HANA Anterior Cervical Plate System
| Sponsor: | Manufacturer: | HUVEXEL Co., Ltd.
101-105 Megacenter, SK Technopark
124 Sagimakgol-ro, Jungwon-gu Seongnam-si
Gyeonggi-do, South Korea |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| | Official Contact: | Milan George
mgeorge@dio-us.com
267-737-9496 x102
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
Number: | 21 CFR 888.3060 | |
| Product
Code/Classification: | KWQ, class II | |
| Description: | The FORTIS and HANA Anterior Cervical Plate System consists of a variety of
shapes and sizes of Main Plates, screw, lock-plate and the associated
instruments. The lock-plate is pre-assembled to the main plate and
designed to prevent screws from backing out. Each component is subjected
to a color anodizing process to differentiate the screw type and diameter
and to make the surgical process easy. The plates range in length to
accommodate one and two-level procedures for HANA and one, two, three,
and four level procedures for FORTIS. Main plate is available from 13mm to
46mm for HANA and 10mm to 112mm for FORTIS. Screws are available in
lengths from 12mm to 20mm for HANA and 10mm to 20mm in 2mm
increments for FORTIS. The screws have either a 4.5mm or 5.1mm diameter
for HANA and 4.0mm or 4.5mm diameter for FORTIS. They are fixed self-
tapping, variable self-tapping screw, fixed self-drilling screw, variable self-
drilling.
The FORTIS and HANA Anterior Cervical Plate System components are
supplied non-sterile, are single use and are fabricated from titanium allow
(Ti-6Al-4V ELI) that conforms to ASTM F136. | |
| 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. | |
| 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: Huvexel - Rex Anterior Cervical Plate System (K121862)
Additional predicate: Globus Medical – VIP Anterior Cervical Plate System
(K081391), Synthes Spine - Synthes Anterior CSLP System (K000742), EBI -
EBI Anterior Cervical Plate System (K001794) and Aesculap – Aesculap ABC
Cervical Plating System (K974706) | |
| Performance and SE
Determination: | The FORTIS and HANA Anterior Cervical Plate System has been
demonstrated to be 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). | |
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