(102 days)
Not Found
No
The summary describes a mechanical implant system and manual surgical instruments, with no mention of software, algorithms, or AI/ML capabilities. The performance studies focus on mechanical testing.
Yes
This device is intended for "temporary stabilization of the anterior spine during the development of cervical spinal fusion," which is a treatment for various spinal conditions, indicating a therapeutic purpose.
No
Explanation: The Atrax Anterior Cervical Plating System is used for anterior fixation and temporary stabilization of the cervical spine, acting as an implant to aid spinal fusion rather than to diagnose a condition.
No
The device description explicitly states it consists of screws, plates, and manual surgical instruments, which are physical hardware components.
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 of the cervical spine" and is used during spinal fusion surgery. This is a surgical implant used directly on the patient's body.
- Device Description: The description details screws and plates made of titanium alloy, which are physical implants. It also mentions surgical instruments for insertion.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (like blood, urine, or tissue) outside of the body to diagnose a condition. IVDs are used to provide information about a patient's health status through the analysis of biological samples.
This device is a surgical implant used for structural support in the spine, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Atrax Anterior Cervical Plating System is anterior fixation of the cervical spine. The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with the following: Degenerative Disc Disease (as identified by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), Spondylolisthesis, Trauma (i.e., fracture or dislocation), Spinal tumors, Deformity (e.g., kyphosis, lordosis, scoliosis), Pseudarthrosis, and/or Failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Atrax Anterior Cervical Plating System consists of screws and plates offered in various sizes so that adaptations can be made to take into account pathology and individual patient anatomy. The Atrax System allows for anterior fixation of between one and four intervertebral segments between C2 and C7.
The Atrax Anterior Cervical Plating System implants are manufactured from Titanium alloy in accordance with ASTM F136 and will be provided sterile (gamma irradiation). All implants are intended for single use only and should not be reused under any circumstances.
The system includes a series of manual surgical instruments intended to assist the insertion and placement of the implants. The instrumentation will be packaged and sold clean but non-sterilization cycle is recommended in the Atrax System draft Instructions for Use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (between C2 and 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)
Biocompatibility:
Implants of the Atrax Anterior Cervical Plating System are made of titanium alloy. The titanium alloy conforms to ASTM F136 – Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. The titanium material has a long history of use as surgical implants and has been proven to be biocompatible, corrosion-resistant, and not toxic to the biologic environment. The product is ultrasonically cleaned using process. ISO 1099-5 cytotoxicity studies will be performed on production.equivalent implants to confirm no cytotoxic residue has been left on the implant following manufacture.
All instrument pieces that will be contacting patient anatomy are manufactured of medical-grade materials with long history of use in the medical setting and have been proven to be biocompatible: (medical-grade stainless steel, medical-grade Radel® plastic). The tissue contact is in limited-exposure settings.
Mechanical Performance:
To demonstrate substantial equivalence based on mechanical performance, X-spine's proposed device, Atrax Anterior Cervical Plating System device, and the predicate device, Medtronic Sofamor Danek's ZEPHIR Anterior Cervical Plate System, were subjected to testing per FDA guidance and recommendations. Mechanical testing was performed on both systems per ASTM F1717-14, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model. The tests performed were:
- Static Compression Bending
- Static Torsion
- Dynamic Compression Bending
The mechanical testing results indicate that the Atrax Anterior Cervical Plating System is substantially equivalent to the predicate device performance and is capable of safely and effectively performing in accordance with its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, flowing line style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 10, 2015
X-spine Systems, Incorporated David Kirschman, MD Chief Medical Officer 452 Alexandersville Road Miamisburg, Ohio 45342
Re: K150834
Trade/Device Name: AtraxTM Anterior Cervical Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: May 29, 2015 Received: June 1, 2015
Dear Dr. Kirschman:
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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 – Dr. David Kirschman
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -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)
Device Name
AtraxTM Anterior Cervical Plating System
Indications for Use (Describe)
The Atrax Anterior Cervical Plating System is interior fixation of the cervical spine. The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with the following: Degenerative Disc Disease (as identified by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), Spondylolisthesis, Trauma (i.e., fracture or dislocation), Spinal tumors, Deformity (e.g., kyphosis, lordosis, scoliosis), Pseudarthrosis, and/or 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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K150834 Page 1 of 1
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510(k) Summary
| Submitter/Manufacturer: | X-spine Systems, Inc.
452 Alexandersville Rd.
Miamisburg, OH 45342 |
|--------------------------------------------------------------|--------------------------------------------------------------------------|
| | Telephone (937) 847-8400
FAX (937) 847-8410 |
| Official Contact: | David Kirschman, M.D.
Chief Medical Officer |
| Date Prepared: | 03/27/2015 |
| Establishment Registration Number:
Owner/Operator Number: | 3005031160
9063903 |
ll. DEVICE NAME
| Trade/Proprietary Name: | Atrax™ Anterior Cervical Plating System |
|---|---|
| Common Name: | Cervical Plating System |
| Classification Name: | Spinal intervertebral body fixation orthosis |
| Regulation Number: | 21 CFR §888.3060 |
| Device Class: | Class II |
| Product Code: | KWQ |
lll. PREDICATE DEVICES
- . Primary Predicate: X-spine Systems, Inc. – Spider Cervical Plating System (K052292) o This predicate has not been subject to a design related recall.
- . Additional Predicate: Medronic Sofamor Danek, Inc. – ZEPHIR Anterior Cervical Plate System (K994239 )
DEVICE DESCRIPTION IV.
The Atrax Anterior Cervical Plating System consists of screws and plates offered in various sizes so that adaptations can be made to take into account pathology and individual patient anatomy. The Atrax System allows for anterior fixation of between one and four intervertebral segments between C2 and C7.
The Atrax Anterior Cervical Plating System implants are manufactured from Titanium alloy in accordance with ASTM F136 and will be provided sterile (gamma irradiation). All implants are intended for single use only and should not be reused under any circumstances.
4
The system includes a series of manual surgical instruments intended to assist the insertion and placement of the implants. The instrumentation will be packaged and sold clean but non-sterilization cycle is recommended in the Atrax System draft Instructions for Use.
V. INDICATIONS FOR USE
The Atrax Anterior Cervical Plating System is intended for anterior fixation of the cervical spine. The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with the following: Degenerative Disc Disease (as identified by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), Spondylolisthesis, Trauma (i.e., fracture or dislocation), Spinal tumors, Deformity (e.g., kyphosis, lordosis, scoliosis), Pseudarthrosis, and/or Failed previous fusion.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Temporary stabilization of the anterior spine during the development of cervical spinal fusion is the technological principle for both the subject and predicate devices. It is based on screw and plate fixation of the anterior spine.
At a high level, the subject device and the primary predicate device and secondary predicate device are based on the following same or equivalent technological elements:
- . Components manufactured using the same titanium alloy
- Plates contain screw socket designs for variability in screw placement
- Screws contain bone threads to aid in fixation
- Screws offered in multiple lengths to account for variations in patient anatomy
- . Plates offered in multiple lengths to account for variations in patient anatomy
- Equivalent Intended uses
- Same anatomical region
- . Same surgical approach
- Mechanical Performance
The following technological differences exist between the subject and predicated devices:
- . Overall envelope size of the Atrax System plates are slightly larger, however the axial and lordotic curvatures are equivalent.
- . Mechanical testing performances were greater in bending, torsional, and fatigue resistance.
- The Atrax implants will be supplied sterile. The predicate devices are supplied non-sterile.
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VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility
Implants of the Atrax Anterior Cervical Plating System are made of titanium alloy. The titanium alloy conforms to ASTM F136 – Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. The titanium material has a long history of use as surgical implants and has been proven to be biocompatible, corrosion-resistant, and not toxic to the biologic environment. The product is ultrasonically cleaned using process. ISO 1099-5 cytotoxicity studies will be performed on production.equivalent implants to confirm no cytotoxic residue has been left on the implant following manufacture.
All instrument pieces that will be contacting patient anatomy are manufactured of medical-grade materials with long history of use in the medical setting and have been proven to be biocompatible: (medical-grade stainless steel, medical-grade Radel® plastic). The tissue contact is in limited-exposure settings.
Mechanical Performance
To demonstrate substantial equivalence based on mechanical performance, X-spine's proposed device, Atrax Anterior Cervical Plating System device, and the predicate device, Medtronic Sofamor Danek's ZEPHIR Anterior Cervical Plate System, were subjected to testing per FDA guidance and recommendations. Mechanical testing was performed on both systems per ASTM F1717-14, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model. The tests performed were:
- Static Compression Bending
- Static Torsion
- . Dynamic Compression Bending
The mechanical testing results indicate that the Atrax Anterior Cervical Plating System is substantially equivalent to the predicate device performance and is capable of safely and effectively performing in accordance with its intended use.
VIII. CONCLUSION
Based on evaluations referenced in this summary, X-spine finds that the Atrax Anterior Cervical Plating System is substantially equivalent to the referenced predicate device systems.