(105 days)
Not Found
No
The document describes a physical implantable device and its mechanical testing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1, after six weeks of non-operative treatment, which describes a medical condition and a treatment to address it.
No
The device is an interbody fusion device used to treat degenerative disc disease, not to diagnose it.
No
The device description explicitly details physical components made of PEEK and titanium alloy, including interbodies, locking mechanisms, and bone anchors. This indicates it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical implantation in the cervical spine to treat degenerative disc disease. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a physical implant made of PEEK and titanium, designed to provide structural support and promote fusion. This is consistent with a surgical implant, not a diagnostic reagent or instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Genesys Spine Cervical Stand-Alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Genesys Spine Cervical Stand-Alone System is to be used with autogenous bone graft and implanted via an anterior approach.
Product codes
OVE
Device Description
The Genesys Spine AIS-C Cervical Stand-Alone System includes PEEK interbodies and titanium interbodies, which utilize an integrated titanium alloy locking mechanism. Both PEEK interbodies and titanium interbodies are to be anchored to patient anatomy via two (2) titanium alloy bone anchors.
The integrated fixation anchors may not provide adequate stability for all situations. The Surgeon should consider the appropriate fixation required for each patient and determine if additional supplemental fixation (e.g. anterior plate, posterior cervical screws) may be needed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, one level from C2-T1
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 Genesys Spine AIS-C Cervical Stand-Alone System was tested in static and dynamic axial compression, compressive-shear, and torsion per ASTM F2077-11, static subsidence per ASTM F2267-04, expulsion testing, and cadaver testing. The system was also tested to determine the force to overcome the locking mechanism under worst-case conditions. These results were compared to the predicate devices to establish substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
K113559, K180056, K152099, K103034
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
August 29, 2018
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 Benjamin Keller Product Development Engineer 1250 Capital of Texas Highway South Building 3 Suite 600 Austin, Texas 78746
Re: K181295
Trade/Device Name: Genesys Spine AIS-C Cervical Stand-Alone System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: July 26, 2018 Received: July 30, 2018
Dear Mr. Keller:
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 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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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,
Melissa Hall -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181295
Device Name
Genesys Spine AIS-C Cervical Stand-Alone System
Indications for Use (Describe)
The Genesys Spine Cervical Stand-Alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Genesys Spine Cervical Stand-Alone System is to be used with autogenous bone graft and implanted via an anterior approach.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/1 description: The image shows the logo for Genesys Spine. The word "Genesys" is written in a combination of brown and gray letters, with the "Ge" in brown and the rest in gray. To the left of the word "Genesys" is a brown graphic that resembles a stylized spine. Below the word "Genesys" is the word "spine" in brown, with a registered trademark symbol next to it.
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: | Benjamin V. Keller (Primary) William W. Sowers (Secondary) |
| Submitter's Telephone: | 512-381-7093 512-381-7080 |
| Submitter's Fax: | 800-817-4938 800-817-4938 |
| Date Summary was Prepared: | August 23, 2018 |
| Trade or Proprietary Name: | Genesys Spine AIS-C Cervical Stand-Alone System |
| Common or Usual Name: | Intervertebral Body Fusion Device, Cervical |
| Classification Name: | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Classification: | Class II per 21 CFR §888.3080 |
| Regulation Number: | 21 CFR 888.3080 |
| Product Codes: | OVE |
| Classification Panel: | Orthopedic Devices Panel |
| Legally Marketed (unmodified) devices to Which Substantial Equivalence is Claimed: | Primary Predicate: |
| LDR Spine Cervical Interbody Fusion System – ROI-C (K113559) | |
| Additional Predicate Devices: | |
| Genesys Spine AIS-C Anchored Cervical Interbody Fusion System (K180056) | |
| Genesys Spine Apache® Anchored Cervical Interbody Fusion System (K152099) | |
| Genesys Spine Apache® IBFD System (K103034) |
4
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Genesys Spine AIS-C Cervical Stand-Alone System includes PEEK interbodies and titanium interbodies, which utilize an integrated titanium alloy locking mechanism. Both PEEK interbodies and titanium interbodies are to be anchored to patient anatomy via two (2) titanium alloy bone anchors.
The integrated fixation anchors may not provide adequate stability for all situations. The Surgeon should consider the appropriate fixation required for each patient and determine if additional supplemental fixation (e.g. anterior plate, posterior cervical screws) may be needed.
INDICATIONS FOR USE
The Genesys Spine Cervical Stand-Alone System is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Genesys Spine Cervical Stand-Alone System is to be used with autogenous bone graft and implanted via an anterior approach.
TECHNICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The Genesys Spine AIS-C Cervical Stand-Alone System is comprised of two versions of interbodies, each of which are secured by integrated fixation Anchors. The interbodies are available in a PEEK configuration with tantalum markers or in a titanium alloy version. Both versions use the same integrated titanium alloy locking mechanism. The interbodies are to be available in several footprints, configurations, and heights. The titanium alloy cervical bone Anchors provide integrated fixation for the system and are to be offered in various lengths. The bone Anchors are deployed through the channels in the interbody and embed into the adjacent cervical vertebrae.
The PEEK interbody devices are made of polyether-ether-ketone (Invibio's PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the PEEK implants contain tantalum markers per ASTM F560 to assist the surgeon with proper placement of the device in the disk space. The titanium alloy interbody devices, anchor locking mechanism, and the bone anchor components are manufactured from medical grade Ti6Al-4V ELI titanium alloy per ASTM F136.
5
The subject and predicate devices are based on the following same technological elements:
- Integrated fixation Anchors provide additional biomechanical support to the interbody
- . Devices are offered in similar sizes and shapes (parallel, lordotic, and convex) which provide surgeons options to suit the patient's anatomy
- . Implants materials are identical: PEEK, Titanium 6Al-4V ELI alloy, and Tantalum
- Use of a single inserter instrument to position the interbodies and deploy the Anchors ●
PERFORMANCE DATA
The predetermined pass-fail criterion was that the mechanical test results for the Genesys Spine Cervical Stand-Alone System be equivalent to (or greater than) previously cleared interbody fusion systems. Prior to performing mechanical testing, all possible configurations of the AIS-C Cervical Stand-Alone System constructs were analyzed in order to determine the worst case to be used for testing.
The Genesys Spine AIS-C Cervical Stand-Alone System was tested in static and dynamic axial compression, compressive-shear, and torsion per ASTM F2077-11, static subsidence per ASTM F2267-04, expulsion testing, and cadaver testing. The system was also tested to determine the force to overcome the locking mechanism under worst-case conditions. These results were compared to the predicate devices to establish substantial equivalence.
CONCLUSION OF NON-CLINICAL TESTS:
The overall technological characteristics and mechanical performance data lead to the conclusion that the Genesys Spine AIS-C Cervical Stand-Alone System is substantially equivalent to the LDR Spine Cervical Interbody Fusion System - ROI-C (K113559), the Genesys Spine AIS-C Anchored Cervical Interbody Fusion System (K180056), the Genesys Spine Apache@ Anchored Cervical Interbody Fusion System (K152099), and the Genesys Spine Apache® IBFD System (K103034).