Vail ALIF Buttress Plate System

K180755 · Evolution Spine, LLC · KWQ · Jul 6, 2018 · Orthopedic

Device Facts

• Record ID: K180755
• Device Name: Vail ALIF Buttress Plate System
• Applicant: Evolution Spine, LLC
• Product Code: KWQ · Orthopedic
• Decision Date: Jul 6, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vail ALIF Buttress Plate System in conjunction with traditional rigid fixation is intended for use in spinal fusion procedures of the thoracolumbar to S1 spinal region as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications.

Device Story

Vail ALIF Buttress Plate System is an anterior, non-load bearing spinal fixation device. Used in thoracolumbar to S1 spinal fusion procedures to maintain position of bone grafts (allografts/autografts). Device features angled flanged shape with spike fixation and single screw. Surgeon engages a visible lock to provide positive visual feedback during fixation. Used in surgical settings by physicians. Benefits include stabilization of graft material during fusion. Provided non-sterile; requires user sterilization.

Clinical Evidence

Bench testing only. Performance data included static and dynamic cantilever bending tests. Results met all specified criteria, demonstrating safety and effectiveness profile equivalent to predicate devices.

Technological Characteristics

Material: Titanium Alloy 6AL-4V ELI (ASTM F136). Design: Angled flanged plate with spike features and single screw fixation. Includes visible lock mechanism. Supplied non-sterile; intended for moist heat sterilization by user. Single use.

Indications for Use

Indicated for patients undergoing spinal fusion procedures in the thoracolumbar to S1 spinal region requiring maintenance of the relative position of weak bony tissue (allografts or autografts). Not for load-bearing applications.

Regulatory Classification

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.

Predicate Devices

• Black Widow Anterior Buttress Plate System (K081770)
• Fang Plate System (K090415)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

Evolution Spine, LLC Mr. Douglas Davis Vice President of Product Development 2300 North Haskell Ave Dallas, Texas 75204

Re: K180755

Trade/Device Name: Vail ALIF Buttress Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: June 19, 2018 Received: June 20, 2018

Dear Mr. Davis:

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

July 6, 2018

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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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Brent Showalter -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K180755

Device Name Vail ALIF Buttress Plate System

### Indications for Use (Describe)

The Vail ALIF Buttress Plate System in conjunction with tradition is intended for use in spinal fusion procedures of the thoracolumbar to S1 spinal region as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|----------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) Summary

### I. SUBMITTER

Evolution Spine, LLC 2300 North Haskell Ave Dallas, TX 75204

Contact person: Douglas Davis Phone: [phone] Date prepared: March 20, 2018

#### II. DEVICE

Name of the device: Vail ALIF Buttress Plate System Common or usual name: Spinal Fixation Device Regulation number: 21 CFR 888.3060 Classification name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ

#### III. PREDICATE DEVICE

Black Widow Anterior Buttress Plate System (K081770) - Primary Predicate This predicate has not been subject to a design-related recall Fang Plate System (K090415) This predicate has not been subject to a design-related recall

#### IV. DEVICE DESCRIPTION

The Vail ALIF Buttress Plate System is an anterior non-load bearing plate system manufactured from Titanium Alloy 6AL-4V ELI per ASTM F136. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The Vail ALIF Buttress Plate System is provided non-sterile, for single use only.

#### V. INDICATIONS FOR USE

The Vail ALIF Buttress Plate System in conjunction with traditional rigid fixation is intended for use in spinal fusion procedures of the thoracolumbar to S1 spinal region as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications.

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### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

At a high level, the subject and predicate devices are based on the following same technological elements:

- all devices are utilized in anterior surgical approaches to intervertebral body fusion
- all devices are fabricated from Titanium alloy meeting the specifications of ASTM F136
- all devices have an angled flanged shape ■
- all devices utilize spike features in conjunction with a single screw for fixation
- all devices are supplied non-sterile, intended for sterilization by moist heat by the user

The following technological differences exist between the subject and predicate devices:

- . The Vail ALIF Buttress Plate System has a visible lock engaged by the surgeon for positive visual feedback during fixation.
#### VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence.

- Static Cantilever Bending
- · Dynamic Cantilever Bending

The Vail ALIF Buttress Plate System met all specified criteria and did not raise new safety or performance questions. Based on the performance testing the Vail ALIF Buttress Plate System was found to have a safety and effectiveness profile that is equivalent to the predicate device.

#### VIII. CONCLUSIONS

The design testing performed for the Vail ALIF Buttress Plate System demonstrated that the performance of the device is substantially equivalent to the legally marketed predicate devices.