Belvedere™ Lateral Plating System

K153097 · Neurostructures, Inc. · KWQ · Jul 15, 2016 · Orthopedic

Device Facts

• Record ID: K153097
• Device Name: Belvedere™ Lateral Plating System
• Applicant: Neurostructures, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Jul 15, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Neurostructures Belvedere™ Lateral Plating System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracolumbar (T1-L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of disco genic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery.

Device Story

Belvedere™ Lateral Plating System consists of titanium alloy plates and screws for spinal fixation; used in lateral or anterolateral surgical approaches to the thoracolumbar spine (T1-L5). Device provides mechanical stabilization for instability caused by fracture, tumor, degenerative disc disease, scoliosis, lordosis, spinal stenosis, or failed prior surgery. Operated by surgeons in an OR setting. Plates and screws are implanted to provide rigid fixation, facilitating spinal fusion or stabilization. Benefits include restoration of spinal alignment and structural support for the vertebral column.

Clinical Evidence

Bench testing only. Testing included static axial compression bending, static torsion, static tension, and dynamic axial compression bending per ASTM F1717-14. Results demonstrate sufficient strength for intended use.

Technological Characteristics

Materials: Titanium alloy 6AL-4V-ELI (ASTM F136). Components: Plates (36-132mm) and screws (5.0-6.5mm diameter, 20-70mm length). Principle: Spinal intervertebral body fixation. Mechanical testing: ASTM F1717-14.

Indications for Use

Indicated for patients requiring stabilization of the thoracolumbar (T1-L5) spine via lateral or anterolateral approach due to fracture, tumor, degenerative disc disease, scoliosis, lordosis, spinal stenosis, or failed previous surgery.

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

• Thoracolumbar Spine Locking Plate (TSLP) System (K020244)
• Black/Red Diamond Rattlesnake Lumbar Plating System (K133194)

Reference Devices

• Palladian™ Lumbar Pedicle Screw System (K143230)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 15, 2016

Neurostructures, Incorporation % Mr. Kenneth Maxwell II Regulatory and Quality Specialist Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K153097

Trade/Device Name: Belvedere™ Lateral Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: June 9, 2016 Received: June 10, 2016

Dear Mr. Maxwell:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Mark N. Melkerson -S

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) K153097

Device Name Belvedere™ Lateral Plating System

#### Indications for Use (Describe)

The Neurostructures Belvedere™ Lateral Plating System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracolumbar (T1-L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of disco genic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery.

| 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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| Submitter's Name: | Neurostructures, Inc. |
|----------------------------|-------------------------------------------------------------------|
| Submitter's Address: | 16 Technology Dr. Suite 165<br>Irvine, CA 92618 |
| Submitter's Telephone: | 800.352.6103 |
| Contact Person: | Kenneth C. Maxwell II<br>Empirical Consulting LLC<br>719.291.6874 |
| Date Summary was Prepared: | 11 July 2016 |
| Trade or Proprietary Name: | Belvedere™ Lateral Plating System |
| Common or Usual Name: | Appliance, Fixation, Spinal Intervertebral Body |
| Classification: | Class II per 21 CFR §888.3060 |
| Product Code: | KWQ |
| Classification Panel: | Division of Orthopedic Devices |

# 510(K) SUMMARY

#### DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The Belvedere™ Lateral Plating System provides an assortment of thoracic and thoracolumbar plates and screws. The plates and screws provided are manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136. Multiple variations of the screws are provided in lengths of 20-70mm and diameters of 5.0-6.5mm. The plates are provided in lengths of 36-132mm.

#### INDICATIONS FOR USE

The NeuroStructures Belvedere™ Lateral Plating System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (T) - L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of disco genic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery.

The indications for use for the Belvedere™ Lateral Plating System are similar to that of predicate devices listed in Table 5-1 Predicate Devices.

### TECHNOLOGICAL CHARACTERISTICS

The Belvedere™ Lateral Plating System and the predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:

- Indications for Use
- Materials of manufacture
- Principles of operation o

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| 510k<br>Number | Trade or Proprietary or Model Name | Manufacturer | Type |
|----------------|--------------------------------------------------------|-----------------------|------------|
| K020244 | Thoracolumbar Spine Locking Plate (TSLP)<br>System | Synthes | Primary |
| K133194 | Black/Red Diamond Rattlesnake Lumbar<br>Plating System | Eminent Spine | Additional |
| K143230 | Palladian™ Lumbar Pedicle Screw System | Neurostructures, Inc. | Reference |

Table 5-1 Predicate Devices

### PERFORMANCE DATA

The Belvedere™ Lateral Plating System has been tested in the following test modes:

- Static axial compression bending per ASTM F1717-14 ●
- Static torsion per ASTM F1717-14 .
- Static tension per ASTM F1717-14 .
- Dynamic axial compression bending per ASTM F1717-14 ●

The results of this non-clinical testing show that the strength of the Belvedere™ Lateral Plating System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

#### CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Belvedere™ Lateral Plating System is substantially equivalent to the predicate device.