(351 days)
No
The device description and intended use focus on the mechanical properties and surgical application of a physical implant (plate and screws) for spinal fusion. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
Yes.
The device is described as an "Anterior Cervical Plate System" intended for "anterior screw fixation to the cervical spine" as an "adjunct to fusion of the cervical spine (C2 to C7)" for various medical conditions like degenerative disc disease, trauma, tumors, and spinal stenosis. Its function is to "stabilize the spine during fusion," which directly addresses and treats a medical condition, qualifying it as a therapeutic device.
No
The device is a spinal implant system used for temporary stabilization and fusion of the cervical spine. It does not perform any diagnostic functions.
No
The device description explicitly states it consists of physical components (plates and screws made of titanium and Nitinol) that are surgically implanted. It is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a surgical implant (an anterior cervical plate system) that is physically inserted into the body to stabilize the spine. It is used as an adjunct to fusion, a surgical procedure.
- Intended Use: The intended use clearly states it's for "anterior screw fixation to the cervical spine" and "temporary stabilization of the anterior spine during the development of cervical spinal fusion." This is a structural and mechanical function within the body, not a diagnostic test performed on a specimen outside the body.
The device's function is to provide mechanical support and stabilization, not to analyze biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Genesys Spine Anterior Cervical Plate II 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 C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, or scoliosis), pseudoarthrosis, failed previous fusion, and/or spinal stenosis.
Product codes
KWQ
Device Description
The Genesys Spine Anterior Cervical Plate II System will be offered in various device configurations based on surgical approach and patient anatomy, and will consist of a Genesys Spine cervical plate and screws that are inserted into the anterior surface of adjacent cervical vertebrae.
The Genesys Spine Anterior Cervical Plate II System is comprised of multiple sizes of plates and screws that are inserted into the anterior surface of adjacent cervical vertebrae. The device is applied after discectomy and insertion of autograft or allograft in the interbody space, and acts to stabilize the spine during fusion.
The plate components are manufactured from medical grade Ti-6Al-4V ELI titanium alloy per ASTM F-136. Additionally, cervical plates contain a securement tab component comprised of Nickel-Titanium (Nitinol) per ASTM F2063-00 to ensure that the screw is locked in place. The bone screws are manufactured from medical grade Ti-6Al-4V ELI titanium alloy per ASTM F-136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2 to C7)
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 predetermined pass-fail criterion was that the mechanical test results for the Genesys Spine Anterior Cervical Plate II System be equivalent to (or greater than) previously cleared anterior cervical plate systems. Prior to performing mechanical testing, all possible configurations of the Anterior Cervical Plate II System construct were analyzed in order to determine the worst case to be used for testing. Static axial compression, static torsion, and dynamic axial compression testing in accordance with American Society for Testing and Materials (ASTM) F1717 "Standard Test Methods for Static and Fatigue for Spinal Implant Constructs in a Vertebrectomy Model" were then performed on the worst case Anterior Cervical Plate II System construct. In addition, corrosion testing was performed in accordance with ASTM F2129
Key Metrics
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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.
October 8, 2014
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Genesys Spine Mr. William W. Sowers Vice President of Quality and Regulatory 1250 Capital of Texas Highway South Building Three. Suite 600 Austin, Texas 78746
Re: K133245
Trade/Device Name: Genesys Spine Anterior Cervical Plate II System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 28, 2014 Received: August 29, 2014
Dear Mr. Sowers:
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
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Page 2 - Mr. William Sowers
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/Resourcesfor You/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 yours,
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) K133245
Device Name
Genesys Spine Anterior Cervical Plate II System
Indications for Use (Describe)
The Genesys Spine Anterior Cervical Plate II 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 C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, failed previous fusion, and/or spinal stenosis.
| 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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5.510(K) SUMMARY
| Submitter's Name: | Genesys Spine |
|---|---|
| Submitter's Address: | 1250 Capital of Texas Highway South |
| Building Three, Suite 600 | |
| Austin, Texas 78746 | |
| Submitter's Telephone: | 512-381-7080 |
| Submitter's Fax: | 800-817-4938 |
| Contact Name: | William W. Sowers |
| Date Summary was | |
| Prepared: | 28-Aug-14 |
| Trade or Proprietary Name: | Genesys Spine Anterior Cervical Plate II System |
| Common or Usual Name: | Spinal Intervertebral Body Fixation Orthosis |
| Classification: | Class II per 21 CFR §888.3060 |
| Product Codes: | KWQ |
| Classification Panel: | Orthopedic and Rehabilitation Devices Panel |
| Legally Marketed | |
| (unmodified) device: | Genesys Spine Anterior Cervical Plate System (Primary |
| Predicate K111132), Synthes Anterior CSLP System | |
| (K000536 / K945700), Pioneer Aspect Anterior Cervical | |
| Plate System | |
| (K130427) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Genesys Spine Anterior Cervical Plate II System will be offered in various device configurations based on surgical approach and patient anatomy, and will consist of a Genesys Spine cervical plate and screws that are inserted into the anterior surface of adjacent cervical vertebrae.
INDICATIONS FOR USE
The Genesys Spine Anterior Cervical Plate II 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 C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or
4
dislocations), tumors, deformity (defined as kyphosis, or scoliosis), pseudoarthrosis, failed previous fusion, and/or spinal stenosis.
TECHNICAL CHARACTERISTICS
The Genesys Spine Anterior Cervical Plate II System is comprised of multiple sizes of plates and screws that are inserted into the anterior surface of adjacent cervical vertebrae. The device is applied after discectomy and insertion of autograft or allograft in the interbody space, and acts to stabilize the spine during fusion.
The plate components are manufactured from medical grade Ti-6Al-4V ELI titanium alloy per ASTM F-136. Additionally, cervical plates contain a securement tab component comprised of Nickel-Titanium (Nitinol) per ASTM F2063-00 to ensure that the screw is locked in place. The bone screws are manufactured from medical grade Ti-6Al-4V ELI titanium alloy per ASTM F-136.
PERFORMANCE DATA
The predetermined pass-fail criterion was that the mechanical test results for the Genesys Spine Anterior Cervical Plate II System be equivalent to (or greater than) previously cleared anterior cervical plate systems. Prior to performing mechanical testing, all possible configurations of the Anterior Cervical Plate II System construct were analyzed in order to determine the worst case to be used for testing. Static axial compression, static torsion, and dynamic axial compression testing in accordance with American Society for Testing and Materials (ASTM) F1717 "Standard Test Methods for Static and Fatigue for Spinal Implant Constructs in a Vertebrectomy Model" were then performed on the worst case Anterior Cervical Plate II System construct. In addition, corrosion testing was performed in accordance with ASTM F2129
CONCLUSION
The overall technological characteristics and mechanical performance data lead to the conclusion that the Genesys Spine Anterior Cervical Plate II System is substantially equivalent to the Genesys Spine Anterior Cervical Plate System (K111132), the Synthes Anterior CSLP System (K000536 / K945700), and the Pioneer Aspect Anterior Cervical Plate System (K130427).