(106 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of a physical implant (plate and screws) for spinal fusion, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is intended for use in the stabilization of the anterior cervical spine during the development of cervical spinal fusion in patients with conditions such as spinal stenosis, degenerative disc disease, tumors, deformity, and/or pseudoarthrosis, indicating it is used for therapeutic purposes.
No
The device is an anterior cervical plate system intended for surgical implantation to stabilize the cervical spine as an adjunct to fusion. Its purpose is to provide mechanical support, not to diagnose medical conditions.
No
The device description clearly states it is a "plate and screw system composed of medical grade titanium Ti-Alloy" and describes physical components like plates, screws, and instruments for implantation. This indicates a hardware-based medical device, not a software-only one.
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 screw fixation to the cervical spine" and is used "in the stabilization of the anterior cervical spine during the development of cervical spinal fusion." This describes a surgical implant used to provide structural support and facilitate bone fusion.
- Device Description: The description details a "plate and screw system composed of medical grade titanium" and its mechanical function in providing support.
- 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 compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is an in vivo (inside the body) implant.
N/A
Intended Use / Indications for Use
The Axis Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion from levels C2 through T1 of the system is indicated for use in the stabilization of the anterior cervical spine during the development of cervical spinal fusion in patients. The indications include spinal stenosis, degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,), tumors, deformity (defined by kyphosis, lordosis, or scoliosis), and/or pseudoarthrosis (defined as failed previous fusion).
Product codes
KWQ
Device Description
Axis Anterior Cervical Plate System is a plate and screw system composed of medical grade titanium Ti-Alloy (Ti-6Al-4V ELI) components. The titanium plates are available in a variety of lengths, addressing multiple levels of fixation. The plates contain an integrated locking mechanism which interfaces with fixed and variable angled screws, of various diameters and lengths, to accommodate anatomical variation when securing the plate-screw construct to the anterior cervical vertebral bodies. The system is intended to provide mechanical support to the implanted level(s) until fusion is achieved. To accommodate normal cervical spine lordosis, and at the same time eliminate the need for additional plate contouring, Axis Anterior Cervical Plates come with a prelordosed curve. Various instruments are available to facilitate the implantation of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (levels C2 through T1)
Indicated Patient Age Range
skeletally mature patients
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
The AXIS Orthopaedics Anterior Cervical Plate system was designed as an adjunct to fusion in the cervical spine. The objective of this testing was to demonstrate that the subject AXIS device is equivalent to a predicate device with respect to testing recommended in ASTM F1717-15 and ASTM F543-13e1.
Static compressive bending, static torsion, and fatigue compression testing was performed per ASTM F1717-15 and demonstrated that the subject plate performed equivalently to the predicate device.
An engineering comparison has been provided (Appendix A) that shows a geometric comparison between the subject AXIS device and a mechanical predicate (Exactech Ambassador). Additionally, the subject screws performed sufficiently to pass the evaluation criteria set forth in the protocol that was derived from the applicable ASTM standard.
Key Metrics
Not Found
Predicate Device(s)
K021461, K091926, K143576, K031276
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.
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April 5, 2018
Axis Orthopaedics % Mr. Steve Brown OA/RA Manager CoorsTek Medical 560 W. Golf Course Rd Providence, Utah 84332
Re: K173867
Trade/Device Name: Axis 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: March 22, 2018 Received: March 23, 2018
Dear Mr. Brown:
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);
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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,
Katherine D. Kavlock -S
for 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) K173867
Device Name
Axis Anterior Cervical Plate System
Indications for Use (Describe)
The Axis Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion from levels C2 through T1 of the system is indicated for use in the stabilization of the anterior cervical spine during the development of cervical spinal fusion in patients. The indications include spinal stenosis, degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,), tumors, deformity (defined by kyphosis, lordosis, or scoliosis), and/or pseudoarthrosis (defined as 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) |
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510(k) SUMMARY
| Device Trade Name: | Axis Anterior Cervical Plate System |
|---|---|
| Date: | December 8, 2017 |
| Sponsor: | Axis Orthopaedics |
| Contact Person: | Steve Brown |
| Manufacturer: | Axis Orthopaedics |
| Common Name: | Axis Anterior Cervical Plate System |
| Device Classification: | Class II |
| Classification Name: | Spinal intervertebral body fixation orthosis |
| Regulation: | 888.3060 |
Device Regulation Panel: Orthopedic
Device Product Code: KWQ
Purpose:
The purpose of this Traditional 510(k) submission is to gain clearance for the Axis Anterior Cervical Plate System.
Device Description:
Axis Anterior Cervical Plate System is a plate and screw system composed of medical grade titanium Ti-Alloy (Ti-6Al-4V ELI) components. The titanium plates are available in a variety of lengths, addressing multiple levels of fixation. The plates contain an integrated locking mechanism which interfaces with fixed and variable angled screws, of various diameters and lengths, to accommodate anatomical variation when securing the plate-screw construct to the anterior cervical vertebral bodies. The system is intended to provide mechanical support to the implanted level(s) until fusion is achieved. To accommodate normal cervical spine lordosis, and at the same time eliminate the need for additional plate contouring, Axis Anterior Cervical Plates come with a prelordosed curve. Various instruments are available to facilitate the implantation of the device.
Indications for Use:
The Axis Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion from levels C2 through T1 of the cervical spine. The system is indicated for use in the stabilization of the anterior cervical spine during the development of cervical spinal fusion in patients. The indications include spinal stenosis, degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,), tumors, deformity (defined by kyphosis, lordosis, or scoliosis), and/or pseudoarthrosis (defined as failed previous fusion).
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Legally Marketed Predicate Devices:
Primary: Medtronic Atlantis Vision Anterior Cervical Plate System (K021461) Secondary: Exactech Ambassador Anterior Cervical Plate System (K091926 and K143576) DePuy Synthes Vectra Anterior Cervical Plate System (K031276)
Implant Materials
| Material: | Standard: |
|---|---|
| Ti-6Al-4V | ASTM F136-13 |
Technological Characteristics:
There are no technological characteristics that raise new issues of safety or effectiveness.
Assessment of performance data:
The AXIS Orthopaedics Anterior Cervical Plate system was designed as an adjunct to fusion in the cervical spine. The objective of this testing was to demonstrate that the subject AXIS device is equivalent to a predicate device with respect to testing recommended in ASTM F1717-15 and ASTM F543-13e1.
Static compressive bending, static torsion, and fatigue compression testing was performed per ASTM F1717-15 and demonstrated that the subject plate performed equivalently to the predicate device.
An engineering comparison has been provided (Appendix A) that shows a geometric comparison between the subject AXIS device and a mechanical predicate (Exactech Ambassador). Additionally, the subject screws performed sufficiently to pass the evaluation criteria set forth in the protocol that was derived from the applicable ASTM standard.
Conclusion:
Based on the above information, it can be concluded that the subject device is substantially equivalent with respect to its mechanical performance, to the mechanical predicate.