(450 days)
No
The device description and performance studies focus on the mechanical properties and materials of a spinal implant system, with no mention of AI or ML technologies.
Yes
The device is intended for "anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease... trauma (including fractures), tumors, deformity (kyphosis, or scoliosis), pseudoarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis," which are all conditions that require treatment.
No
The device description indicates that the FlexWing Anterior Cervical Plate System is an implant used for screw fixation in the cervical spine. Its purpose is to provide structural support and stability, not to diagnose medical conditions or analyze patient data to determine a diagnosis.
No
The device description clearly states it is a "FlexWing Anterior Cervical Plate System" made of Titanium Alloy and Nickel-Titanium Alloy, consisting of plates and bone screws. This describes a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "anterior screw fixation to the cervical spine" for various conditions. This describes a surgical implant used to stabilize the spine.
- Device Description: The description details the materials and components of a surgical implant (plates and screws).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs typically involve tests performed outside the body.
The device described is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The FlexWing Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine(C2-T1) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, or scoliosis), pseudoarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
Product codes
KWQ
Device Description
The FlexWing Anterior Cervical Plate System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1.
The FlexWing Anterior Cervical Plate System is made of Titanium Alloy (Ti-6AL-4V) and Nickel-Titanium Alloy, which meet ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI(Extra Low Interstitial) Alloy for Surgical Implant Applications, and ASTM F2063, Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants. The Anterior Cervical Plates consist of 1 to 3 levels which have different lengths. The bone screws are 3.5 and 4.0mm in diameter with self-tapping and selfdrilling threads and provided in lengths from 10.0 to 26.0mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-T1)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Non-Clinical Test Summary:
The following tests were performed per ASTM F1717 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model on Anterior Cervical Spine Plate System to demonstrate substantial equivalence of the subject device.
- . Static Compression Bending
- Static Torsion
- Compression Bending Fatigue ●
Additionally, screw pushout testing and ASTM F2129 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices were performed to demonstrate substantial equivalence of the subject device.
Clinical Test Summary:
No clinical studies were considered necessary and performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
July 24, 2024
Image /page/0/Picture/1 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 the FDA logo, which 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.
Jeil Medical Corporation Sejin Ryu RA Manager 702,703,704,705,706,804,805,807,812,815-ho, 55 Digital-ro 34-gil, Guro-gu Seoul. 08378 Korea, South
Re: K231251
Trade/Device Name: FlexWing 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: July 19, 2024 Received: July 19, 2024
Dear Sejin Ryu:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Image /page/1/Picture/7 description: The image shows a digital signature. The signature is from Eileen Cadel. The date of the signature is July 24, 2024, and the time is 11:53:40 -04'00'.
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
2
Indications for Use
Submission Number (if known)
Device Name
FlexWing Anterior Cervical Plate System
Indications for Use (Describe)
The FlexWing Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine(C2-T1) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, or scoliosis), pseudoarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
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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3
510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)|
July 19, 2024
.
.
2. Submitter's Information [21 CFR 807.92(a)(1)]
- Name of Sponsor: Jeil Medical Corporation
- 702.703.704.705.706.804.805.807.812.815-ho, 55, Digital-ro 34-gil, Address:
Guro-gu, Seoul, 08378, Republic of Korea
- Contact Name: Sejin Ryu / RA Manager
- Telephone No.: +82 2 850 3583 ●
- . Fax No.: +82 2 850 3536
- . Email Address: rsj@jeilmed.co.kr
- Registration Number: 3004049923
- Name of Manufacturer: Same as Sponsor
- . Address: Same as Sponsor
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Trade Name; | FlexWing Anterior Cervical Plate System |
|---|---|
| Common Name; | Anterior Cervical Plate System |
| Classification Name; | Spinal Intervertebral Body Fixation Orthosis |
| Classification Panel; | Orthopedic |
| Classification Regulation; | 21 CFR 888.3060 |
| Product Code; | KWQ |
| Device Class; | II |
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)[
The legally marketed device(s) to which substantial equivalence is claimed is/are:
| Primary Predicate | K192314 - RESONATE™ Anterior Cervical Plate System,
Globus Medical Inc |
|----------------------|---------------------------------------------------------------------------|
| Additional Predicate | K030866 - Synthes Anterior CSLP System,
SYNTHES |
| Reference Device | K180972 - ARIX Clavicle System,
JEIL MEDICAL CORPORATION |
4
There are no significant differences between the subject device and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, materials, and operational principles as anterior cervical plate system.
5. Description of the Device [21 CFR 807.92(a)(4)]
The FlexWing Anterior Cervical Plate System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1.
The FlexWing Anterior Cervical Plate System is made of Titanium Alloy (Ti-6AL-4V) and Nickel-Titanium Alloy, which meet ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI(Extra Low Interstitial) Alloy for Surgical Implant Applications, and ASTM F2063, Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants. The Anterior Cervical Plates consist of 1 to 3 levels which have different lengths. The bone screws are 3.5 and 4.0mm in diameter with self-tapping and selfdrilling threads and provided in lengths from 10.0 to 26.0mm.
6. Indications for Use [21 CFR 807.92(a)(5)]
The Flex Wing Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, or scoliosis), pseudoarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
The rationale for substantial equivalence is based on consideration of the following characteristics:
Regulatory Classification: Same as the predicate devices Indications for Use: Substantially equivalent (SE) to the predicate devices Materials: Substantially equivalent (SE) to the predicate devices Design Features: Substantially equivalent (SE) to the predicate devices
Non-Clinical Test Summary:
The following tests were performed per ASTM F1717 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model on Anterior Cervical Spine Plate System to demonstrate substantial equivalence of the subject device.
- . Static Compression Bending
- Static Torsion
- Compression Bending Fatigue ●
Additionally, screw pushout testing and ASTM F2129 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices were performed to demonstrate substantial equivalence of the subject device.
Clinical Test Summary:
No clinical studies were considered necessary and performed.
5
8. Substantial Equivalence [21 CFR 807.92(b)(3)]
When compared to the predicate device (K140234, K030866), the FlexWing Anterior Cervical Plate
System presented in this submission has similar:
- Indications for Use
- . Technological characteristics
- Function
- Design features
- . Performance
- . Biocompatibility
- Method of sterilization.
9. Conclusion [21 CFR 807.92(b)(3)]
The information provided within this premarket notification demonstrates that proposed device is determined to be substantially equivalent (SE) to the predicate devices.