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.

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.

AI/ML Overview

This FDA 510(k) summary does not contain the information required to answer your request. The document describes a spinal fixation orthosis (Vy Spine™ VyWasher™ Buttress System) which is a physical medical device, not a device that relies on algorithms or AI for performance.

Therefore, the following information regarding acceptance criteria, study details, expert involvement, and ground truth establishment, which are typical for software-based medical devices or AI algorithms, are not present in this submission:

A table of acceptance criteria and the reported device performance.
Sample size used for the test set and the data provenance.
Number of experts used to establish the ground truth for the test set and their qualifications.
Adjudication method for the test set.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers' improvement with AI vs. without AI assistance.
If a standalone (algorithm only) performance study was done.
The type of ground truth used.
The sample size for the training set.
How the ground truth for the training set was established.

Instead, this document focuses on establishing substantial equivalence for a physical implantable device based on material, design, sizes, intended use, and biocompatibility compared to predicate devices, along with non-clinical testing (which would typically involve mechanical or material strength testing, not clinical performance against ground truth).

Summary

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December 23, 2021

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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

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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)

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

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.

Regulation Number and Section

§ 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.