(111 days)
No
The device description focuses solely on the mechanical components and function of the cervical plating system. There is no mention of AI, ML, image processing, or any data-driven decision-making within the device's operation.
Yes.
The device is an anterior cervical plating system intended for fixation of the cervical spine to support fusion for various indications, which directly addresses a medical condition or disease.
No
The device description indicates it is a plating system for anterior cervical fixation to improve spinal stability and support fusion, not to diagnose medical conditions.
No
The device description clearly outlines physical components made of Ti-6Al-4V ELI alloy, such as bone screws and plates, intended for surgical implantation. This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that the Mediant™ Anterior Cervical Plating System is an implantable device consisting of plates and screws used for anterior cervical fixation. It is surgically placed within the body to stabilize the spine.
- Intended Use: The intended use describes the conditions for which the device is used in the body (degenerative disc disease, trauma, etc.) and its function in supporting fusion.
- Lack of IVD Characteristics: There is no mention of testing samples, analyzing biological markers, or providing diagnostic information based on in vitro analysis.
Therefore, the Mediant™ Anterior Cervical Plating System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Intelligent Implant Systems Mediant™ Anterior Cervical Plating System is intended for anterior cervical fixation for the following indications: 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, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Product codes
KWO
Device Description
The Intelligent Implant Systems' Mediant™ Anterior Cervical Plating System consists of bone screws (4.0 and 4.5 mm diameter) of various lengths and a series of plates for fusion of 1-. 2-. or 3- levels of the cervical spine (C2-T1).
The device functions as follows: An appropriately sized plate is placed on the anterior aspect of the vertebral body of the cervical spine by inserting either a 4.0 mm or a 4.5 mm diameter bone screw through the cephalad and caudad holes and into the vertebral body. The device improves stability of the spine while supporting fusion.
The Mediant™ cervical plates are provided in multiple lengths from 19 mm (one-level) through 78 mm (three-level) for one-, two- and three-level fusions. The thickness of all plates is 2.2 mm and the width is 19.0 mm. All plates interface with the same cervical bone screws. which are either 4.0 mm diameter or 4.5 mm diameter. The bone screws can best be described as semi-constrained, but can be inserted at any angle (within a ±18° angular variation) to the plate. A slider mechanism then locks the bone screws to the plate at the angle of insertion using the supplied locking pliers. The bone screw will remain fixed at the angle of insertion unless bone resorption results in high loading levels on the bone screws. If this occurs, due to the polyaxiality of the screw, the screw will re-position itself and re-lock at the new angle.
All implant components of the Mediant™ Anterior Cervical Plating system are manufactured from Ti-6Al-4V ELI alloy, conforming 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-T1)
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:
To validate the strength and safety of the system components. testing was conducted according to methods defined in ASTM F 1717-15, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model". The types of testing performed are listed below:
-
- Static Compression Bending
-
- Static Torsional Bending
-
- Dynamic Compression Bending
The testing revealed that the mechanical properties of the Mediant™ cervical plating system were comparable to published values for anterior plating systems and to the predicate devices.
- Dynamic Compression Bending
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency's name in a lighter shade of blue.
April 16, 2018
Intelligent Implant Systems, LLC Michael Nutt Chief Operating Officer 3300 International Airport Dr, Suite 1100 Charlotte, North Carolina 28208
Re: K173935
Trade/Device Name: Mediant™ Anterior Cervical Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWO Dated: March 14, 2018 Received: March 15, 2018
Dear Mr. Nutt:
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 (QS) regulation (21 CFR Part 820);
1
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 mediation-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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Indications for Use
510(k) Number (if known) K173935
Device Name
Mediant™ Anterior Cervical Plating System
Indications for Use (Describe)
The Intelligent Implant Systems Mediant™ Anterior Cervical Plating System is intended for
anterior cervical fixation for the following indications: 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, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY Intelligent Implant Systems' Mediant™ Anterior Cervical Plating System
| I. Submitter: | Intelligent Implant Systems, LLC
3300 International Airport Drive, Suite 1100
Charlotte, NC 28208
(704) 424-1009
(704) 424-1011 (FAX) |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michael Nutt
Chief Operations Officer
(704) 424-1009 |
Date Prepared: April 11, 2018
II. Device
Name of Device: Mediant™ Anterior Cervical Plating System Common or Usual Name: Plate and Screw Cervical Spinal Fixation System Classification Name: Spinal Intervertebral Body Fixation Orthosis (21 CFR 888.3060) Regulatory Class: II Product Codes: KWQ
III. Predicate Devices
Primary Predicate: Synthes Spine Anterior CSLP System (K030866, K945700)
Additional Predicate: Spinal Innovations SPECTRUM™ Cervical Spinal System (K022997)
IV. Device Description
The Intelligent Implant Systems' Mediant™ Anterior Cervical Plating System consists of bone screws (4.0 and 4.5 mm diameter) of various lengths and a series of plates for fusion of 1-. 2-. or 3- levels of the cervical spine (C2-T1).
The device functions as follows: An appropriately sized plate is placed on the anterior aspect of the vertebral body of the cervical spine by inserting either a 4.0 mm or a 4.5 mm diameter bone screw through the cephalad and caudad holes and into the vertebral body. The device improves stability of the spine while supporting fusion.
The Mediant™ cervical plates are provided in multiple lengths from 19 mm (one-level) through 78 mm (three-level) for one-, two- and three-level fusions. The thickness of all plates is 2.2 mm and the width is 19.0 mm. All plates interface with the same cervical bone screws. which are either 4.0 mm diameter or 4.5 mm diameter. The bone screws can best be
4
described as semi-constrained, but can be inserted at any angle (within a ±18° angular variation) to the plate. A slider mechanism then locks the bone screws to the plate at the angle of insertion using the supplied locking pliers. The bone screw will remain fixed at the angle of insertion unless bone resorption results in high loading levels on the bone screws. If this occurs, due to the polyaxiality of the screw, the screw will re-position itself and re-lock at the new angle.
All implant components of the Mediant™ Anterior Cervical Plating system are manufactured from Ti-6Al-4V ELI alloy, conforming to ASTM F136.
V. Intended Use / Indications for Use
Intended Use:
The Mediant™ Anterior Cervical Plate implants are intended to be used as a construct that assists in normal healing and are not intended to replace normal body structures. The system is intended to stabilize the spinal operative site during anterior fusion with a plate and screws.
Indications for Use:
The Intelligent Implant Systems MEDIANT™ Anterior Cervical Plating System is intended for anterior cervical fixation for the following indications: 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.
VI. Comparison of Technological Characteristics with the Predicate Devices
The Mediant™ Anterior Cervical Plate System and the predicate devices are all anterior systems utilizing screw and plate fixation for stabilization of spinal segments. The subject and predicate devices all have the following technological characteristics:
- Bone screws attach the plate to vertebral bodies
- Locking mechanism secures screws to the plate ●
- Plates are low profile and available in a variety of sizes to conform to patient anatomy .
The following technological differences exist between the subject and predicate devices:
- The Mediant™ Anterior Cervical Plating system utilizes a locking mechanism which . is secured by moving a slider to the locked position with a pair of locking pliers. This contrasts with the predicate CSLP device which uses a locking screw.
- . The Mediant™ Anterior Cervical Plating bone screws can be inserted at the angle desired by the surgeon, within a circumferential range of ± 18°. Both predicate devices have a smaller angular range of motion.
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VII. Performance Data
The following performance data are provided in support of the substantial equivalence determination:
Mechanical Testing:
To validate the strength and safety of the system components. testing was conducted according to methods defined in ASTM F 1717-15, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model". The types of testing performed are listed below:
-
- Static Compression Bending
-
- Static Torsional Bending
-
- Dynamic Compression Bending
The testing revealed that the mechanical properties of the Mediant™ cervical plating system were comparable to published values for anterior plating systems and to the predicate devices.
VIII. Conclusions
The design of the Mediant™ Anterior Cervical Plate system is similar to the predicate devices, it functions in a similar manner, and its mechanical properties are comparable. Thus, the Mediant™ Anterior Cervical Plating system was found to have a safety and effectiveness profile similar to the predicate devices.