(85 days)
Not Found
No
The summary describes a mechanical implant (washers and screws) for spinal fusion and provides no indication of software, algorithms, or data processing that would involve AI/ML.
No.
The device is intended to stabilize a bone graft and provide temporary stabilization for spinal fusion, not to treat a disease or condition itself.
No
The device is described as an implantable system for stabilizing bone grafts and providing temporary stabilization for spinal fusion, without any mention of diagnosing conditions.
No
The device description explicitly states that the system consists of "washers and bone screws," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The Vy Spine™ VyWasher™ Buttress System is a surgical implant. Its purpose is to physically stabilize bone graft and provide temporary stabilization during spinal fusion surgery. It is implanted directly into the patient's body.
The description clearly indicates a device used in vivo (within the body) for structural support, not a device used in vitro (outside the body) for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The Vy Spine™ VyWasher™ Buttress System is intended to stabilize the bone graft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Vy Spine™ VyWasher™ Buttress System is a temporary implant used to prevent bone graft extrusion. The Vy Spine™ VyWasher™ Buttress System consists of washers and bone screws. The Vy Spine™ VyWasher™ Buttress System is also intended to provide stabilization and augment development of a solid spinal fusion. The Vy Spine™ VyWasher™ Buttress System fixates to the anterior portion of the thoracolumbar vertebral body. The construct may be employed alone, or with other anterior, anterolateral, or posterior spinal systems made of compatible materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
T1-S1 (thoracolumbar vertebral body)
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: The subject Vy Spine™ VyWasher™ Buttress System has the same material, design, sizes, indication of use & biocompatibility as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Reliance Buttress Washer (K073349)
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.
Not Found
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).
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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December 23, 2021
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 consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size.
Vy Spine, LLC Jordan Hendrickson Operations Manager 2236 Capital Circle NE, Suite 103-1 Tallahassee, Florida 32308
Re: K213219
Trade/Device Name: Vy Spine™ VyWasher™ Buttress System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: September 25, 2021 Received: September 29, 2021
Dear Jordan Hendrickson:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 mediation-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
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213219
Device Name
Vy Spine™ VyWasher™ Buttress System
Indications for Use (Describe)
The Vy Spine™ VyWasher™ Buttress System is intended to stabilize the bone graft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
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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510(k) Summarv
21 December 2021
Vy Spine, LLC 2236 Capital Circle NE. Suite 103-1 Tallahassee. FL 32308 Telephone: 866-489-7746 850-597-8571 Fax:
Contact: Jordan Hendrickson Operations Manager
510(k) Number: Common or Usual Name: Proposed Proprietary or Trade Name: Classification Name: Regulation Number: Product Code:
Anterior Thoracolumbar Buttress System Vy Spine™ VyWasher™ Buttress System Spinal Intervertebral Body Fixation Orthosis 21 CFR 888.3060 KWO
Substantial Equivalence
The Vy Spine™ VyWasher™ Buttress System is substantially equivalent to the primary predicate device Reliance Buttress Washer (K073349). The Vy Spine™ VyWasher™ Buttress System is equivalent to these commercially available devices in terms of material, intended use, levels of attachment, size range, and use with supplemental fixation.
Predicate Devices
The Reliance Buttress Washer (K073349) is the primary predicate for the Vy Spine™ VyWasher™ Buttress System
Device Description
The Vy Spine™ VyWasher™ Buttress System is a temporary implant used to prevent bone graft extrusion. The Vy Spine™ VyWasher™ Buttress System consists of washers and bone screws. The Vy Spine™ VyWasher™ Buttress System is also intended to provide stabilization and augment development of a solid spinal fusion. The Vy Spine™ VyWasher™ Buttress System fixates to the anterior portion of the thoracolumbar vertebral body. The construct may be employed alone, or with other anterior, anterolateral, or posterior spinal systems made of compatible materials.
Intended Use/Indications for Use
The Vy Spine™ Vy Washer™ Buttress System is intended to stabilize the bone graft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
Non-Clinical Testing
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The subject Vy Spine™ VyWasher™ Buttress System has the same material, design, sizes, indication of use & biocompatibility as the predicate devices.
Technological Modifications
The subject Vy Spine™ VyWasher™ Buttress System has the same material, design, sizes, indication of use & biocompatibility as the predicate devices.
Technological Characteristics
The subject Vy Spine™ VyWasher™ Buttress System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to have equivalent technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and function. This device does not contain software or electrical equipment.