(162 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and structural integrity of the implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an "Anterior Cervical Fixation System" intended for "anterior screw fixation to the cervical spine" as an "adjunct to fusion of the cervical spine." It is used for "temporary stabilization of the anterior spine during the development of cervical spinal fusions" in patients with various conditions such as degenerative disc disease, trauma, and tumors. These characteristics indicate its use in treating medical conditions, fitting the definition of a therapeutic device.
No
The device is described as a fixation system for the cervical spine, used as an adjunct to fusion. Its function involves stabilization and attachment of a plate to the vertebral body with screws, which are therapeutic actions, not diagnostic.
No
The device description clearly outlines physical components like plates and screws, indicating it is a hardware-based medical device, not software-only.
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 ZION Anterior Cervical Fixation System is for "anterior screw fixation to the cervical spine" as an "adjunct to fusion." This describes a surgical implant used to stabilize the spine during a fusion procedure.
- Device Description: The description details a "cervical plate" and "bone screws" that are "attached to the vertebral body." This is consistent with a surgical implant, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, tissue, etc.) to provide information about a patient's health status, disease, or condition.
IVD devices are used in vitro (outside the body) to examine specimens. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The ZION Anterior Cervical Fixation 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 of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radios), 2) spondylolisthesis, 3) trauma (including fractures or dislocations), 4) tumors, 5) defined as kyphosis, or scoliosis, 6) pseudarthrosis, 7) failed previous fusions and/or 8) spinal stenosis.
Product codes
KWQ
Device Description
The Astura Medical ZION Anterior Cervical Fixation System is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping or self-drilling bone screws using an anterior approach. Plates are available in a variety of lengths addressing multiple levels of fixation. The ZION ACFS plate incorporates graft windows on the longitudinal center line for intraoperative visualization and for screw fixation of bone graft. Fixed or variable bone screws are available in two diameters and a variety of lengths, with self-tapping or self-drilling thread options.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2 to 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
No clinical studies were performed
Key Metrics
Not Found
Predicate Device(s)
K132012, K060025, K080646, K000536, K042544
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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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 23, 2016
Astura Medical % J.D. Webb President The OrthoMedix Group, Incorporated 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K160702
Trade/Device Name: ZION Anterior Cervical Fixation System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 17, 2016 Received: August 18, 2016
Dear J.D 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. 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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.
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,
VincentJ. Devlin -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K160702
Device Name
ZION Anterior Cervical Fixation System
Indications for Use (Describe)
The ZION Anterior Cervical Fixation 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 of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radios), 2) spondylolisthesis, 3) trauma (including fractures or dislocations), 4) tumors, 5) defined as kyphosis, or scoliosis, 6) pseudarthrosis, 7) failed previous fusions and/or 8) spinal stenosis.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Form Approved: OMB No. 0910-0120
Expiration Date: December 31, 2013
See PRA Statement on last page.
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510(k) Summary: ZION Anterior Cervical Fixation System
| Date Prepared | May 20, 2016 |
|---|---|
| Submitted By | Astura Medical |
| 5670 El Camino Real, Suite B | |
| Carlsbad, CA 92008 | |
| 760-814-8047 Tele | |
| email: info@asturamedical.com | |
| Contact | J.D. Webb |
| 1001 Oakwood Blvd | |
| Round Rock, TX 78681 | |
| 512-388-0199 Tele | |
| e-mail: jdwebb@orthomedix.net | |
| Trade Name | ZION Anterior Cervical Fixation System |
| Common Name | anterior cervical plate |
| 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 | Zimmer Trinica/Trinica Select Anterior Cervical Plate (K132012) |
| Secondary Predicate | |
| Devices | Spinal USA Slimpicity Anterior Cervical Plating System (K060025) |
| Biomet C-TekV MaxAnrm Anterior Cervical Plate System (K080646) | |
| Synthes CLSP Cervical Plate (K000536) | |
| DePuy UNIPLATE Anterior Cervical Plate (K042544 / K082273 / K100070) | |
| Device Description | The Astura Medical ZION Anterior Cervical Fixation System is intended for |
| anterior screw fixation of the plate to the cervical spine. The fixation construct | |
| consists of a cervical plate that is attached to the vertebral body of the cervical | |
| spine with self-tapping or self-drilling bone screws using an anterior approach. | |
| Plates are available in a variety of lengths addressing multiple levels of | |
| fixation. The ZION ACFS plate incorporates graft windows on the | |
| longitudinal center line for intraoperative visualization and for screw | |
| fixation of bone graft. Fixed or variable bone screws are available in two | |
| diameters and a variety of lengths, with self-tapping or self-drilling thread | |
| options. | |
| Materials | Titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 |
| Nitinol conforming to ASTM F2063 | |
| Substantial | |
| Equivalence Claimed | |
| to Predicate Devices | The ZION Anterior Cervical Fixation System is substantially equivalent to the |
| predicate devices in terms of intended use, design, materials used, mechanical | |
| safety and performances. | |
| Indications for Use | The ZION Anterior Cervical Fixation 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 of the cervical spine (C2 to T1). The system is indicated for use | |
| in the temporary stabilization of the anterior spine during the development of | |
| cervical spinal fusions in patients with: 1) degenerative disc disease (as defined | |
| by neck pain of discogenic origin with degeneration of the disc confirmed by | |
| patient history and radiographic studies), 2) spondylolisthesis, 3) trauma | |
| (including fractures or dislocations), 4) tumors, 5) deformity (defined as kyphosis, | |
| lordosis, or scoliosis), 6) pseudarthrosis, 7) failed previous fusions and/or 8) | |
| spinal stenosis. | |
| Non-clinical Test | |
| Summary | The following analyses were conducted: |
| ● Static and dynamic compression testing per ASTM F1717 | |
| ● Static torsion testing per ASTM F1717 | |
| ● Corrosion testing (ASTM F2129) | |
| The results of these evaluations indicate that the ZION Anterior Cervical Fixation | |
| System is equivalent to the predicate devices. | |
| Clinical Test | |
| Summary | No clinical studies were performed |
| Conclusions: Non- | |
| clinical and Clinical | Astura Medical considers the ZION Anterior Cervical Fixation 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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