Boundary Anterior Lumbar Buttress Plate

K173091 · Nvision Biomedical Technologies, LLC · KWQ · Dec 6, 2017 · Orthopedic

Device Facts

• Record ID: K173091
• Device Name: Boundary Anterior Lumbar Buttress Plate
• Applicant: Nvision Biomedical Technologies, LLC
• Product Code: KWQ · Orthopedic
• Decision Date: Dec 6, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft at one level (L1-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 Story

The Boundary Anterior Lumbar Buttress Plate is a spinal fixation system designed to stabilize allograft or autograft at one lumbar/lumbosacral level (L1-S1). The device consists of a contoured plate and a screw; the plate is fixed to the anterior surface of the vertebral body, extending over the adjacent intervertebral space to act as a buttress for the interbody graft. It is used by surgeons in an operating room setting to provide temporary stabilization during the spinal fusion process. The device may be used alone or in conjunction with other spinal systems. It does not support load-bearing applications. Clinical benefit is derived from maintaining graft position and providing stability to facilitate successful spinal fusion.

Clinical Evidence

Bench testing only. Static and dynamic cantilever bending tests were performed in accordance with ASTM F1717-13 to demonstrate mechanical integrity and substantial equivalence to predicate devices.

Technological Characteristics

Spinal intervertebral body fixation orthosis. Features a contoured plate and screw system for anterior lumbar/lumbosacral fixation. Employs self-tapping and self-drilling screws. Mechanical performance validated via static and dynamic cantilever bending per ASTM F1717-13. No software or electronic components.

Indications for Use

Indicated for patients requiring stabilization of allograft or autograft at one level (L1-S1) as an aid to spinal fusion and temporary stabilization to augment solid spinal fusion development. 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

• RCS® Anterior Buttress Plate System / Precision Spine, Inc. (K092659)
• Anterior Buttress Plate System / Genesys Spine (K133911)
• Tangis Anterior Cervical Plate / Nvision Biomedical Technologies,LLC (K161524)

Submission Summary (Full Text)

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December 6, 2017

Nvision Biomedical Technologies, LLC % Allison C. Komiyama, Ph.D., R.A.C. Principal Consultant AcKnowledge Regulatory Strategies, LLC 2834 Hawthorn Street San Diego, California 92104

Re: K173091

Trade/Device Name: Boundary Anterior Lumbar Buttress Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: September 28, 2017 Received: September 29, 2017

Dear Dr. Komiyama:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Ronald P. Jean -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)

#### K173091

Device Name Boundary Anterior Lumbar Buttress Plate

#### Indications for Use (Describe)

The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft at one level (L1-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)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for Nvision Biomedical Technologies. The "n" in Nvision is gold and the rest of the word is black. Underneath the word Nvision is the phrase "Biomedical Technologies" in gold.

# 510(k) Summary

DATE PREPARED September 28, 2017

### MANUFACTURER AND 510(k) OWNER

Nvision Biomedical Technologies, LLC 350 N Loop 1604 E #103, San Antonio, TX 78232, USA Telephone: Official Contact: Diana L. Langham, Director of Regulatory and Corporate Compliance

### REPRESENTATIVE/CONSULTANT

Allison C. Komiyama, Ph.D., R.A.C. Lucie Dalet, Ph.D. AcKnowledge Regulatory Strategies, LLC Telephone: Email: [e-mail]

#### PROPRIETARY NAME OF SUBJECT DEVICE

Boundary Anterior Lumbar Buttress Plate

#### COMMON NAME

Appliance, Fixation, Spinal Intervertebral Body

#### DEVICE CLASSIFICATION

Spinal intervertebral body fixation orthosis (21 CFR 888.3060, Product Code KWQ, Class II)

#### PREMARKET REVIEW

ODE/DOD/ASDB Orthopedic Panel

#### INDICATIONS FOR USE

The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft or autograft at one level (L1-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.

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# DEVICE DESCRIPTION

The Boundary Anterior Lumbar Buttress Plate is a fixation system used as a buttress of the interbody, to stabilize the allograft or autograft at one level during the development of a spinal fusion. The device consists in a plate shaped to conform to the anatomy of the anterior lumbar and lumbosacral spine (L1-S1). A screw fixates the system to the anterior surface of the vertebral body, allowing the plate to extend onto the adjacent intervertebral space. The buttress end of the plate may be oriented either caudal or cephalad. The Boundary Anterior Lumbar Buttress Plate may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials.

## PREDICATE DEVICE IDENTIFICATION

The Boundary Anterior Lumbar Buttress Plate is substantially equivalent to the following predicates:

| 510(k)<br>Number | Predicate Device Name / Manufacturer | Primary<br>Predicate |
|------------------|----------------------------------------------------------------------|----------------------|
| K092659 | RCS® Anterior Buttress Plate System / Precision Spine, Inc. | ✓ |
| K133911 | Anterior Buttress Plate System / Genesys Spine | |
| K161524 | Tangis Anterior Cervical Plate / Nvision Biomedical Technologies,LLC | |

## SUMMARY OF NON-CLINICAL TESTING

No FDA performance standards have been established for the Boundary Anterior Lumbar Buttress Plate. The following tests were performed to demonstrate safety based on current industry standards:

- . Static Cantilever Bending per ASTM F1717-13
- . Dynamic Cantilever Bending per ASTM F1717-13

The results of these tests indicate that the Boundary Anterior Lumbar Buttress Plate is substantially equivalent to the predicate devices.

## EQUIVALENCE TO PREDICATE DEVICES

Nvision believes that the Boundary Anterior Lumbar Buttress Plate is substantially equivalent to the predicate devices based on the information summarized here:

The subject device has a similar design and dimension as the devices cleared in K092659 and K133911. The subject device uses similar or identical materials as the devices cleared in K092659, K133911, and K161524. The subject device has similar intended use and similar technological characteristics (self-tapping and self-drilling screws) as the devices cleared in K092659 and K133911. These technological characteristics have undergone testing to ensure the device is as safe and effective as the predicates.

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Image /page/5/Picture/1 description: The image is a logo for "nVision Biomedical Technologies". The "n" is in gold and the rest of the word is in black. Underneath the word "nVision" is the phrase "BIOMEDICAL TECHNOLOGIES" in gold.

## CONCLUSION

Based on the testing performed, including static and dynamic cantilever bending, it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed Boundary Anterior Lumbar Buttress Plate are assessed to be substantially equivalent to the predicate devices. The device is considered safe and effective for its intended use.