(254 days)
Not Found
No
The 510(k) summary describes a mechanical spinal implant system and does not mention any AI or ML components or functionalities.
No
Therapeutic devices are generally defined as those that cure, treat, prevent, or diagnose a disease or condition. This device is described as maintaining the relative position of weak bony tissue, and while it assists in fusion (a treatment), it is considered a mechanical support for grafts rather than an active therapeutic agent itself.
No
The device is described as a "buttress plate system" used in spinal fusion procedures to maintain the relative position of weak bony tissue, not to diagnose a condition.
No
The device description explicitly states it consists of a buttress plate and screws, which are physical hardware components. The performance studies also involve mechanical testing of these physical 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 the device is for use in spinal fusion procedures to maintain the relative position of bony tissue. This is a surgical implant used in vivo (within the body).
- Device Description: The description details a plate and screws inserted into vertebrae, which are physical components used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used directly on the patient's anatomy.
N/A
Intended Use / Indications for Use
The Genesys Spine Anterior Buttress Plate system in conjunction with traditional rigid fixation is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts. This device is not intended for load bearing applications.
Product codes
KWQ
Device Description
The Genesys Spine Anterior Buttress Plate System will be offered in various device configurations based on surgical approach and patient anatomy, and will consist of a Genesys Spine buttress plate and screws that are inserted into the anterior surface of adjacent lumbar vertebrae.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
adjacent lumbar vertebrae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
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Summary of Performance Studies
The predetermined pass-fail criterion was that the mechanical test results for the Genesys Spine Anterior Buttress Plate System be equivalent to (or greater than) previously cleared anterior buttress plate systems. Prior to performing mechanical testing, all possible configurations of the Anterior Buttress Plate System construct were analyzed in order to determine the worst case to be used for testing. Static and dynamic cantilever bending 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 Buttress Plate System construct.
Key Metrics
Not Found
Predicate Device(s)
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 is a black and white 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 it. Inside the circle is a stylized image of three human profiles facing right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 3, 2014
Genesys Spine Mr. Brian J. Bergeron Vice President of Engineering 1250 Capital of Texas Highway South Building Three, Suite 600 Austin, Texas 78746
Re: K133911
Trade/Device Name: Genesys Spine Anterior Buttress Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: July 29, 2014 Received: August 5, 2014
Dear Mr. Bergeron:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/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.
Ronald#Aean -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) K133911
Device Name
Genesys Spine Anterior Buttress Plate System
Indications for Use (Describe)
The Genesys Spine Anterior Buttress Plate system in conjunction with traditional rigid fixation is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts. This device is not intended for load bearing applications.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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: | 512-381-7071 |
| Submitter's Fax: | 512-381-7076 |
| Contact Name: | Brian J. Bergeron |
| Date Summary was | |
| Prepared: | July 29, 2014 |
| Trade or Proprietary Name: | Genesys Spine Anterior Buttress Plate 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 |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Genesys Spine Anterior Buttress Plate System will be offered in various device configurations based on surgical approach and patient anatomy, and will consist of a Genesys Spine buttress plate and screws that are inserted into the anterior surface of adjacent lumbar vertebrae.
Indications for Use
The Genesys Spine Anterior Buttress Plate system in conjunction with traditional rigid fixation is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications.
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TECHNICAL CHARACTERISTICS
The Genesys Spine Anterior Buttress Plate System is comprised of multiple sizes of plates and screws that are inserted into the anterior surface of adjacent lumbar 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, plates contain a securement tab component comprised of medical grade Ti-6Al-4V ELI titanium alloy per ASTM F-136 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 Buttress Plate System be equivalent to (or greater than) previously cleared anterior buttress plate systems. Prior to performing mechanical testing, all possible configurations of the Anterior Buttress Plate System construct were analyzed in order to determine the worst case to be used for testing. Static and dynamic cantilever bending 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 Buttress Plate System construct.
CONCLUSION
The overall technological characteristics and mechanical performance data lead to the conclusion that the Genesys Spine Anterior Buttress Plate System is substantially equivalent to the Black Widow Anterior Buttress Plate (Omni Spine - K081770), BOWTI Anterior Buttress Staple System (Depuy Acromed - K021039), and Butrex Buttress Plating System (X-Spine, Inc. -K072943).