(103 days)
None
No
The device description and performance studies focus on the mechanical properties and surgical application of a physical implant system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is indicated for treatment of various spinal instabilities, which implies a therapeutic purpose.
No
The device is described as an implant system (plates and screws) used for stabilization during spinal fusion, not for diagnosing conditions.
No
The device description explicitly states that the system consists of plates, screws, and manual surgical instruments, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant system used to provide support during spinal fusion procedures. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device consists of plates, screws, and surgical instruments, all of 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, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used to treat a physical condition within the body.
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 great vessels in the treatment of thoracic and thoracolumbar (T1 -L5) spine instability or via the anterior surgical approach, below the bifurcation of the greatment 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, kyphosis, lordosis, spinal stenos is, 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 of the patient. The Genesys Spine Binary Lumbar Plate System implants are manufactured from medical grade Ti-6Al-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
thoracic and 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
Nonclinical testing was performed to demonstrate that the subject Genesys Spine Binary Lumbar Plate System is substantially equivalent to other predicate devices. The following testing was performed:
- Static Compression Bending per ASTM F1717 ●
- Static Torsion per ASTM F1717
- . Dynamic Compression Bending per ASTM F1717
Key Metrics
Not Found
Predicate Device(s)
K142699, K091044, K022791, K052546, K020244
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/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
April 3, 2018
Genesys Spine William W. Sowers VP Quality & Engineering 1250 South Capital of Texas Highway, Building 3 Suite 600 Austin, Texas 78746
Re: K173885
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: March 8, 2018 Received: March 9, 2018
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K173885
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 great vessels in the treatment of thoracic and thoracolumbar (T1 -L5) spine instability or via the anterior surgical approach, below the bifurcation of the greatment 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, kyphosis, lordosis, spinal stenos is, or a failed previous spine surgery.
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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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 | |
| Submitter's Telephone: | 512-381-7080 |
| Submitter's Fax: | 800-817-4938 |
| Contact Name: | William W. Sowers |
| Date Summary was | |
| Prepared: | March 13, 2018 |
| Trade or Proprietary Name: | Genesys Spine Binary Lumbar Plate System |
| Common or Usual Name: | Spinal Fixation System |
| Classification: | Class II per: |
| 21 CFR 888.3060 – Spinal intervertebral body fixation | |
| orthosis | |
| Product Codes: | KWQ |
| Classification Panel: | Orthopedic Devices Panel |
| Legally Marketed | |
| (unmodified) devices to | Primary Predicate: |
| Which Substantial | |
| Equivalence is Claimed: | Stryker LITe Plate System (K142699) |
| Additional Predicate(s): | |
| Spinal USA AccuFit Plate System (K091044), | |
| Synthes Anterior Tension Band System (K022791), | |
| Depuy Aegis Anterior Lumbar Plate (K052546), | |
| Synthes TSLP Thoracolumbar Plate (K020244) |
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 of the patient. The Genesys Spine Binary Lumbar Plate System implants are manufactured from medical grade Ti-6Al-4V ELI titanium alloy per ASTM F136.
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K173885 Page 2 of 2
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, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.
TECHNICAL CHARACTERISTICS
As established in this submission, the Genesys Spine Binary Lumbar Plate System was shown to be substantially equivalent and have equivalent technological characteristics to its predicate devices through comparison in areas including intended use, material composition, principles of operation and design.
PERFORMANCE DATA
Nonclinical testing was performed to demonstrate that the subject Genesys Spine Binary Lumbar Plate System is substantially equivalent to other predicate devices. The following testing was performed:
- Static Compression Bending per ASTM F1717 ●
- Static Torsion per ASTM F1717
- . Dynamic Compression Bending per ASTM F1717
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that Genesys Spine Binary Lumbar Plate System is substantially equivalent to legally marketed predicate devices for intended use, material composition, principles of operation, and design.