(27 days)
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No
The 510(k) summary describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
Yes
The device is described as an implant used for stabilization during spinal fusion for various medical conditions, indicating its therapeutic purpose.
No
The device is described as an implantable system for temporary stabilization and not for diagnosis. Its purpose is to aid in spinal fusion, not to identify or characterize a disease or condition.
No
The device description explicitly states it consists of physical components like titanium/nitinol bone plates, titanium bone screws, and associated instrumentation, which are hardware implants.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided text describes a surgical implant (anterior cervical plate system) used to stabilize the spine during fusion. It is a physical device implanted into the body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states it's for "anterior screw fixation to the cervical spine" and "temporary stabilization of the anterior spine." This is a surgical procedure, not a diagnostic test.
Therefore, based on the provided information, the Genesys Spine Binary Anterior Cervical Plate System is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Genesys Spine Binary 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 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, lordosis, or scoliosis), pseudoarthrosis, failed previous fusion, and/or spinal stenosis.
Product codes (comma separated list FDA assigned to the subject device)
KWO, KWQ
Device Description
The Genesys Spine Binary® Anterior Cervical Plate System components are temporary implants used to stabilize the cervical spine during the development of a solid spinal fusion in patients with degenerative disease, trauma (including fractures), and tumor pathology.
The Genesys Spine Binary® Anterior Cervical Plate System consists of multi-segmented titanium/nitinol bone plates of various sizes and lengths, titanium bone screws in various diameters and lengths, and associated instrumentation. Fixation is provided by the insertion of bone screws into the anterior surface of adjacent cervical vertebrae. Fixation of the screws to the plate is accomplished by seating into the screw securement mechanism.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 29, 2019
Genesys Spine Mr. Andrew C. Davison VP of Quality & Regulatory Affairs 1250 Capital of Texas Highway South Building 3. Suite 600 Austin, Texas 78746
Re: K192076
Trade/Device Name: Binary® Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWO Dated: July 22, 2019 Received: August 2, 2019
Dear Mr. Davison:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for RPJ
Ronald Jean, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192076
Device Name
Binary® Anterior Cervical Plate System
Indications for Use (Describe)
The Genesys Spine Binary Anterior Cervical Plate System is intenor 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, 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | Over-The-Counter Use (21 CFR 801 Subpart C) | ||
| Prescription Use (Part 21 CFR 801 Subpart D) | |||||
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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4. 510(K) SUMMARY
| Submitter's Name: | Genesys Spine | ||
|---|---|---|---|
| Submitter's Address: | 1250 Capital of Texas Highway South | ||
| Building Three, Suite 600 | |||
| Austin, Texas 78746 | |||
| Contact Name: | Andrew C. Davison | ||
| (Primary) | Benjamin V. Keller | ||
| (Secondary) | |||
| Submitter's Telephone: | 512-381-7070 | 512-381-7093 | |
| Submitter's Fax: | 512-381-7076 | 512-381-7076 | |
| Date Summary was | |||
| Prepared: | August 19, 2019 | ||
| Trade or Proprietary | |||
| Name: | Binary® Anterior Cervical Plate System | ||
| Common or Usual Name: | Spinal Intervertebral Body Fixation Orthosis | ||
| Classification: | Class II | ||
| Regulation Number: | 21 CFR 888.3060 – Spinal Intervertebral Body Fixation | ||
| Orthosis | |||
| Product Codes: | KWQ | ||
| Classification Panel: | Orthopedic and Rehabilitation Devices Panel | ||
| Legally Marketed devices | |||
| to Which Substantial | |||
| Equivalence is Claimed: | Primary Predicate: | ||
| Anterior Cervical Plate II System (Genesys Spine - | |||
| K133245) |
PURPOSE OF THE 510(K)
The intent of this Special 510(k) is to:
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- Register additional Screws sizes to the components of the Binary® Anterior Cervical Plate System.
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- Register additional Cervical Plate sizes to the components of the Binary® Anterior Cervical Plate System.
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Genesys Spine Binary® Anterior Cervical Plate System components are temporary implants used to stabilize the cervical spine during the development of a solid spinal fusion in patients with degenerative disease, trauma (including fractures), and tumor pathology.
The Genesys Spine Binary® Anterior Cervical Plate System consists of multi-segmented titanium/nitinol bone plates of various sizes and lengths, titanium bone screws in various diameters and lengths, and associated instrumentation. Fixation is provided by the insertion of
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bone screws into the anterior surface of adjacent cervical vertebrae. Fixation of the screws to the plate is accomplished by seating into the screw securement mechanism.
TECHNICAL CHARACTERISTICS
The Genesys Spine Binary® Anterior Cervical Plate 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.
INDICATIONS FOR USE
The Genesys Spine Binary 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 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.
CONCLUSION
The overall technological characteristics have led to the conclusion that the additional implantable devices in the subject submission do not create a new worst case. As a result, the modified Genesys Spine Binary® Anterior Cervical Plate System is considered substantially equivalent to the previously cleared Genesys Spine Anterior Cervical Plate II System (Genesys Spine - K133245).