RELIANCE VBS SYSTEM

K081383 · Reliance Medical Systems, LLC · MQP · Jul 2, 2008 · Orthopedic

Device Facts

• Record ID: K081383
• Device Name: RELIANCE VBS SYSTEM
• Applicant: Reliance Medical Systems, LLC
• Product Code: MQP · Orthopedic
• Decision Date: Jul 2, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Reliance VBS System is intended for use in the thoracolumbar spine (T1-L5) to replace a portion of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture) in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Reliance VBS is designed to restore biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period of time. The Reliance VBS System is to be used with a legally cleared anterior or posterior supplemental fixation device. Additionally, the Reliance VBS is intended to be used with bone graft.

Device Story

Reliance VBS System is a vertebral body replacement (VBR) spacer; replaces portions of collapsed, damaged, or unstable vertebral bodies in thoracic and lumbar spine (T1-L5). Device acts as a structural spacer to restore vertebral height and biomechanical integrity of spinal column. Used in conjunction with bone graft and legally cleared anterior or posterior supplemental fixation devices. Implanted by surgeons in clinical settings. Benefits include decompression of spinal cord/neural tissues and stabilization of anterior column. Device components include spacer implants and associated surgical instruments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Spinal intervertebral body fixation orthosis. Materials: PEEK with Tantalum markers or Titanium alloy. Form factor: vertebral body spacer. System includes implant and instrument components. No software or electronic components.

Indications for Use

Indicated for patients with collapsed, damaged, or unstable vertebral bodies in the thoracolumbar spine (T1-L5) due to tumor or trauma (fracture) requiring anterior decompression and height restoration. Must be used with supplemental fixation and bone graft.

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

• Reliance VBS System (K063637)
• Pioneer Surgical Vertebral Spacer (K043206)
• Alphatec NOVEL VBR (K042201)
• Quantum Vertebral Body Replacement (K050449)
• K2M Aleutian Spaccr System (K051454)
• Medtronic Sofamor Danek Verte-STACK System (K041556, K041452, K040536, K040422, K040167, K031780, K030736, K030601, K023570, K021791)
• Synthes Vertebral Spacer (K011037, K020152, K024364)

Submission Summary (Full Text)

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K081383

# 510(k) Summary

Reliance Medical Systems 2647 Cassowary Cir Sandy, UT 84092 801-388-0700 Telephone: [phone] Fax:

Contact:

Bret M. Berry Member-Manager

510(k) Number: Common or Usual Name: Proposed Proprietary or Trade Name: Classification Name: Regulation Number: Product Code:

K081383 PEEK or Titanium Bone Fixation Appliance Reliance VBS System Spinal Intervertebral Body Fixation Orthosis 21 CFR 888.3060 MQP

### Substantial Equivalence

The Reliance VBS is substantially equivalent to the legally marketed Reliance VBS System (K063637), the Pioneer Surgical Vertebral Spacer (K043206), the Alphatec NOVEL VBR (K042201), the Quantum Vertebral Body Replacement (K050449), the K2M Aleutian Spaccr System (K051454), the Medtronic Sofamor Danek Verte-STACK System (K041556, K041452, K040536, K040422, K040167, K031780, K030736, K030601, K023570, K021791), and the Synthes Vertebral Spacer (K011037, K020152, K024364). The Reliance VBS is equivalent to these commercially available devices in terms of material, intended use, levels of attachment, size range, and use with supplemental fixation.

#### Device Description

The Reliance VBS System is comprised of implant and instrument components. The implant component, the Reliance VBS device, is a spacer, which replaces a portion of the vertebral bodies in the anterior column of the thoracic and lumbar spine. The spacer may be made of PEEK with Tantalum markers, or made of Titanium alloy.

### Intended Use/Indications for Use

The Reliance VBS System is intended for use in the thoracolumbar spine (T1-L5) to replace a portion of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture) in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Reliance VBS is designed to restore biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period of time.

The Reliance VBS System is to be used with a legally cleared anterior or posterior supplemental fixation device. Additionally, the Reliance VBS is intended to be used with bone graft.

JUL - 2 2008

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle faces right and is positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 2 2008

Reliance Medical Systems % Mr. Bret Berry Member-Manager 2647 Cassowary Circle Sandy, UT 84092

> K081383 Trade/Device Name: Reliance VBS System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: May 15, 2008 Received: June 3, 2008

Dear Mr. Berry:

Re:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.

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Page 2 - Mr. Bret Berry

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone]or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark H. Wilkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): _ KO81 343

# Dovice Name: Reliance VBS System

Indications for Use:

The Reliance VBS System is intended for use in the thoracolumbar spine (T1-L5) to replace a portion of a collapsed, damaged, or unstable vertebral body duc to tumor or trauma (i.e., fracture) in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Reliance VBS is designed to restore biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period of time.

The Rcliance VBS System is to be used with a legally cleared anterior or posterior supplemental fixation device. Additionally, the Reliance VBS is intended to be used with bone graft.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

in Sign. Of Division of General, Restorative,

p57068 Number 1108138