(28 days)
No
The device description and summary of performance studies indicate a mechanical implant system with no mention of AI/ML components or software.
No
The device is described as providing "additional support during fusion" for spine instability, indicating it's a structural support device rather than one that directly treats or cures a condition.
No
The device is an implantable plate and screw system intended for spinal stabilization during fusion, which is a treatment, not a diagnostic process.
No
The device description explicitly states that the system consists of plates, screws, and manual surgical instruments, which are all hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Description: The provided text describes a surgical implant system consisting of plates and screws made of titanium alloy, intended for use in spinal fusion surgery.
- Intended Use: The intended use clearly states that the system is used as additional support during fusion via a surgical approach to treat spinal instability. This is a surgical procedure performed directly on the patient's body, not an in vitro test on a specimen.
The description and intended use are consistent with a Class II or Class III medical device used in surgery, not an IVD.
N/A
Intended Use / Indications for Use
The Genesys Spine Binary® Lumbar Plate System is indicated as additional support during fusion via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1 -L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor. degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery.
Product codes
KWO, KWQ
Device Description
The Genesys Spine Binary Lumbar Plate System consists of an assortment of plates and screws. The Binary Lumbar Plate System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
Implant components are available in a variety of sizes to suit the individual pathology and anatomical conditions. The Genesys Spine Binary Lumbar Plate System implants are manufactured from medical grade Ti-6A1-4V ELI titanium alloy per ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar (T1 -L5) spine, lumbar and lumbosacral (L1-S1) spine
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)
Engineering analysis was performed on the subject devices and it was determined that a new worst-case was not created, therefore additional testing was not required. The instrument additions mimic previously cleared instruments with minor alterations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
October 24, 2019
Image /page/0/Picture/1 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.
Genesys Spine Chloe Lance Ouality Assurance Engineer II 1250 Capital of Texas Highway South Building 3 Suite 600 Austin, Texas 78746
Re: K192678
Trade/Device Name: Genesys Spine Binary® Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWO Dated: September 23, 2019 Received: September 26, 2019
Dear Chloe Lance:
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
Ronald Jean 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K192678
Device Name
Genesys Spine Binary® Lumbar Plate System
Indications for Use (Describe)
The Genesys Spine Binary Lumbar Plate System is indicated as additional support during fusion via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1 -L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor. degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery.
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)
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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: | Chloe Lance | |
| (Primary) | William W. Sowers | |
| (Secondary) | ||
| Submitter's Telephone: | 512-381-7089 | 512-381-7080 |
| Submitter's Fax: | 512-381-7076 | 512-381-7076 |
| Date Summary was | ||
| Prepared: | September 23, 2019 | |
| Trade or Proprietary | ||
| Name: | Genesys Spine Binary® Lumbar Plate System | |
| Common or Usual Name: | Spinal Intervertebral Body Fixation Orthosis | |
| Classification Name: | Class II per 21 CFR §888.3060 | |
| 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 | ||
| (unmodified) devices to | ||
| Which Substantial | ||
| Equivalence is Claimed: | Primary Predicate: | |
| Binary Lumbar Plate System (Genesys Spine – K173885) |
PURPOSE OF THE 510(K)
The intent of this Special 510(k) is to:
-
- Add additional Lumbar Sacral Plates to the Binary Lumbar Plate System
-
- Add / revise system instrumentation
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Genesys Spine Binary Lumbar Plate System consists of an assortment of plates and screws. The Binary Lumbar Plate System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
Implant components are available in a variety of sizes to suit the individual pathology and anatomical conditions. The Genesys Spine Binary Lumbar Plate System implants are manufactured from medical grade Ti-6A1-4V ELI titanium alloy per ASTM F136.
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K192678 Page 2 of 2
TECHNICAL CHARACTERISTICS
The Genesys Spine Binary Lumbar Plate System is comprised of multiple sizes of plates and screws that are inserted via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels of the lumbar spine. The system is designed to provide additional support during fusion. It has equivalent technological characteristics to its predicate device through comparison in areas including intended use, material, composition, principles of operation and design.
INDICATIONS FOR USE
The Genesys Spine Binary Lumbar Plate System is indicated as additional support during fusion via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1 -L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery.
PERFORMANCE DATA
Engineering analysis was performed on the subject devices and it was determined that a new worst-case was not created, therefore additional testing was not required. The instrument additions mimic previously cleared instruments with minor alterations.
CONCLUSION
The overall technological characteristics have led to the conclusion that the additional devices in the subject submission do not create a new worst case. The system remains as safe and as effective and performs as well or better than the current legally marketed device. As a result, the modified Genesys Spine Binary Lumbar Plate System is considered substantially equivalent to the previously cleared Genesys Spine Binary Lumbar Plate System (Genesys Spine - K173885).