(48 days)
No
The device description and intended use focus on mechanical stabilization and fusion, with no mention of AI/ML technologies or related concepts like image processing, data analysis, or predictive capabilities.
No.
The device is described as a system for temporary stabilization and fixation of the spine during the development of spinal fusions, not for treating a disease or condition itself.
No
Explanation:
The device is described as an "Anterior Cervical Plate System" intended for "temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions." This indicates it is a surgical implant designed for mechanical support and fusion, not for diagnosing conditions. Its purpose is treatment, not diagnosis.
No
The device description explicitly states it consists of "bone plates, screws... and associated instruments," which are physical hardware components, 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 that the device is for "temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions." This describes a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The description confirms it consists of "temporary implants that are intended for anterior interbody screw fixation of the cervical spine." This further reinforces its role as a surgical implant.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with bodily specimens outside the body.
Therefore, the NexGen Anterior Cervical Plate System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NexGen Anterior Cervical Plate System is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: degenerative disc disease (DDD) (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (including fractures or dislocations); spinal tumors; deformity (defined as kyphosis, lordosis, or scoliosis); spinal stenosis; pseudoarthrosis; and failed previous fusions.
Product codes
KWQ
Device Description
The NexGen Anterior Cervical Plate System components are temporary implants that are intended for anterior interbody screw fixation of the cervical spine during the development of a cervical spinal fusion. The NexGen Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates, screws (available in self-drilling or self-tapping configurations), and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior spine from C2 to 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)
Non-clinical Test Summary: The following analyses were conducted:
• Static and dynamic compression and torsion per ASTM F1717
The results of these evaluations show that the NexGen Anterior Cervical Plate System is as strong or stronger than the predicate devices.
Clinical Test Summary: No clinical studies were performed
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K160702, K080646, K000536, K042544, K082273, K100070
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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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October 29, 2019
Image /page/0/Picture/1 description: The image shows 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 text logo on the right. The FDA text logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
Precision Spine % Mr. J.D. Webb The OrthoMedix Group, Inc. 4313 W. 3800 S. West Haven, Utah 84401
Re: K192494
Trade/Device Name: NexGen 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 10, 2019 Received: September 11, 2019
Dear Mr. Webb:
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. 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 located 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.
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
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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 4, Subpart A) for combination products; 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 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,
for
(Ronald Jean) Vacant Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192494
Device Name NexGen Anterior Cervical Plate System
Indications for Use (Describe)
The NexGen Anterior Cervical Plate System is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: degenerative disc disease (DDD) (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (including fractures or dislocations); spinal tumors; deformity (defined as kyphosis, or scoliosis); spinal stenosis; pseudoarthrosis; and failed previous fusions.
| 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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510(k) Summary:
| Date Prepared | September 10, 2019 |
|---|---|
| Submitted By | Precision Spine |
| 2050 Executive Drive | |
| Pearl, MS 39208 | |
| Primary Contact | J.D. Webb |
| 4313 W. 3800 S | |
| West Haven, UT 84401 | |
| 512-590-5810 | |
| e-mail: jdwebb@orthomedix.net | |
| Secondary Contact | Michael C. Dawson |
| Precision Spine | |
| 2050 Executive Drive | |
| Pearl, MS 39208 | |
| 973-455-7150 ext. 128 | |
| Trade Name | NexGen Anterior Cervical Plate System |
| Common Name | Anterior Cervical Plate System |
| Classification Name | Spinal intervertebral body fixation orthosis |
| Class | II |
| Product Code | KWQ |
| CFR Section | 21 CFR section 888.3060 |
| Device Panel | Orthopedic |
| Primary Predicate | |
| Device | Zion Anterior Cervical Plating System, Astura Medical (K160702) |
| Secondary Predicate | |
| Devices | C-Tek® MaxAn™Anterior Cervical Plate System, Biomet (K080646) |
| CSLP Cervical Plate, Synthes (K000536) | |
| UNIPLATE, DePuy (K042544 / K082273 / K100070) | |
| Reference Device | AccuFit™ Lateral Plate System, Precision Spine (K162211) |
| Device Description | The NexGen Anterior Cervical Plate System components are temporary implants that are |
| intended for anterior interbody screw fixation of the cervical spine during the development | |
| of a cervical spinal fusion. The NexGen Anterior Cervical Plate System consists of a variety | |
| of shapes and sizes of bone plates, screws (available in self-drilling or self-tapping | |
| configurations), and associated instruments. Fixation is provided by bone screws inserted | |
| into the vertebral body of the cervical spine using an anterior approach. | |
| Materials | Implants are made from Ti-6Al-4V ELI conforming to ASTM F136. |
| Intended Use | The NexGen Anterior Cervical Plate System is intended for anterior interbody screw |
| fixation of the cervical spine during the development of a cervical spinal fusion. | |
| Substantial | |
| Equivalence Claimed | |
| to Predicate Devices | The NexGen Anterior Cervical Plate System is substantially equivalent to the |
| predicate devices in terms of | |
| intended use, design, materials used, and | |
| mechanical performance. | |
| Indications for Use | The NexGen Anterior Cervical Plate System is indicated for use in temporary stabilization |
| of the anterior spine from C2 to T1 during the development of cervical spinal fusions in | |
| patients with: degenerative disc disease (DDD) (as defined by neck pain of discogenic | |
| origin with degeneration of disc confirmed by patient history and radiographic studies); | |
| spondylolisthesis; trauma (including fractures or dislocations); spinal tumors; deformity | |
| (defined as kyphosis, lordosis, or scoliosis); spinal stenosis; pseudoarthrosis; and failed | |
| previous fusions. | |
| Summary of the | |
| technological | |
| characteristics | |
| compared to | |
| predicate | When compared to the predicate devices, NexGen Anterior Cervical Plate System has the |
| same intended use and similar technological characteristics, including: | |
| • Design | |
| • Function/Performance | |
| • Principle of Operation | |
| • Materials of Construction | |
| • Fundamental Scientific Technology | |
| Non-clinical Test | |
| Summary | The following analyses were conducted: |
| • Static and dynamic compression and torsion per ASTM F1717 | |
| The results of these evaluations show that the NexGen Anterior Cervical Plate System is | |
| as strong or stronger than the predicate devices. | |
| Clinical Test | |
| Summary | No clinical studies were performed |
| Conclusions: Non- | |
| clinical and Clinical | Precision Spine considers the NexGen Anterior Cervical Plate System to be equivalent to |
| the predicate devices listed above. This conclusion is based upon the devices' similarities | |
| in principles of operation, technology, materials and indications for use |
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
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