ATLAS SPINE VERTEBRAL BODY REPLACEMENT

K063464 · Atlas Spine, Inc. · MQP · Mar 9, 2007 · Orthopedic

Device Facts

• Record ID: K063464
• Device Name: ATLAS SPINE VERTEBRAL BODY REPLACEMENT
• Applicant: Atlas Spine, Inc.
• Product Code: MQP · Orthopedic
• Decision Date: Mar 9, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Atlas Spine Vertebral Body Replacement (VBR) is intended for use in the thoracolumbar spine (T1-L5) for partial or complete replacement (i.e., vertebrectorny) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Atlas Spine VBR is also indicated for treating fractures of the thoracic and lumbar spine. The Atlas Spine VBR is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The interior of the Atlas Spine VBR can be packed with bone. This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

Device Story

Rectangular, radiolucent vertebral body replacement (VBR) device; implanted in thoracic or lumbar spine (T1-L5) following partial or complete vertebrectomy. Device restores biomechanical integrity of spinal column; interior packable with bone graft. Features four radiopaque markers for postoperative radiographic positioning confirmation. Used in conjunction with cleared supplemental spinal fixation systems (e.g., pedicle screw/rod, anterior plate). Intended for surgical use by physicians to treat tumors or fractures; provides structural support to spinal column.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and functional characteristics compared to predicate devices.

Technological Characteristics

Implantable PEEK (polyetheretherketone) polymer; rectangular form factor; radiolucent body with four radiopaque markers for radiographic visualization. Mechanical device; no energy source or software components.

Indications for Use

Indicated for patients requiring partial or complete vertebral body replacement in the thoracolumbar spine (T1-L5) due to tumors or fractures. Used to achieve anterior decompression and restore vertebral height. Requires use with supplemental spinal fixation systems.

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

• Novel™ VBR Spinal System (K050553)
• Pioneer Vertebral Body Replacement Device (K043206, K061151)
• Quantum Vertebral Body Replacement (K050449, K052641, K061576, K062004)

Submission Summary (Full Text)

{0}------------------------------------------------

Atlas Spine, Inc. 510(k) Premarket Notification: Atlas Spine Vertebral Body Replacement ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

K063464
MAR 09 2007

## 510(k) SUMMARY

| Manufacturer:<br>Address: | Atlas Spine, Inc.<br>1555 Jupiter Park Drive, Suite #4<br>Jupiter, FL 33458 |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone:<br>Fax: | 561-741-1108<br>561-741-1870 |
| Official Correspondent:<br>Title:<br>Telephone: | Jeannette G. Dailey<br>VP Regulatory Affairs<br>561-354-4319 |
| Device Classification<br>Name: | Spinal intervertebral body fixation orthosis |
| Trade/Proprietary Name: | Atlas Spine Vertebral Body Replacement |
| Common Name: | Spinal vertebral body replacement device |
| Classification: | Class II per 21 CFR §888.3060 |
| Product Code: | MQP |
| Predicate Devices: | Novel™ VBR Spinal System<br>K050553<br>Pioneer Vertebral Body Replacement Device<br>K043206, K061151<br>Quantum Vertebral Body Replacement<br>K050449, K052641, K061576, K062004 |

Intended Use:

The Atlas Spine Vertebral Body Replacement (VBR) is intended for use in the thoracolumbar spine (T1-L5) for partial or complete replacement (i.e., vertebrectorny) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Atlas Spine VBR is also indicated for treating fractures of the thoracic and lumbar spine.

The Atlas Spine VBR is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The interior of the Atlas Spine VBR can be packed with bone. This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

{1}------------------------------------------------

Device Description:

The Atlas Spine VBR is a rectangular, radiolucent vertebral body replacement device designed to replace, in whole or in part, a thoracic or lumbar vertebral body after complete or partial vertebrectomy.

The device design includes four radiopaque markers, two on the superior surface and two on the inferior surface, in opposing corners, that allow postoperative radiographic confirmation of the device position and orientation.

### Equivalence to Marketed Product

Atlas Spine, Inc. has submitted information to demonstrate that, for the purpose of FDA's regulation of medical devices, the Atlas Spine VBR is substantially equivalent in indications and design principles to predicate devices that have been determined by FDA to be substantially equivalent to preamendment devices.

The intended use, design, materials and functional characteristics of the Atlas Spine VBR and the predicate devices are substantially the same. The height, width, length and lordotic angle of the Atlas Spine VBR are within the ranges available for one or more of the predicate devices. Each system is intended to be used to provide support after resection or removal of a damaged, collapsed, or unstable vertebral body due to tumor, fracture, or other disease. The subject device and predicate devices are placed within the area of removed or resected spine and are functionally complemented by supplemental internal fixation. The subject device and the predicate devices are intended to be used with bone graft. The Atlas Spine VBR and predicate devices are made from implantable PEEK [polyetheretherketone] polymer.

{2}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The text is in all caps and is written in a simple, sans-serif font. The eagle is depicted in a minimalist style, with clean lines and a sense of motion.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Atlas Spine, Inc. % Mrs. Jeannette Dailey Vice President, Regulatory Affairs 1555 Jupiter Park Drive, Suite 4 Jupiter, Florida 33458

MAR 0 3 2007

K063464 Trade/Device Name: Atlas Spine Vertebral Body Replacement Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: February 16, 2007 Received: February 20, 2007

Dear Mrs. Dailey:

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.

{3}------------------------------------------------

Page 2 - Mrs. Jeannette Dailey

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 Office of Compliance at (240) 2760-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Vor
Mark N. Mullen

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

Enclosure

{4}------------------------------------------------

Atlas Spine, Inc. 510(k) Premarket Notification: Atlas Spine Vertebral Body Replacement ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

# Indications for Use

510(k) Number (if known): 土063469

Device Name: Atlas Spine Vertebral Body Replacement

Indications for Use:

The Atlas Spine Vertebral Body Replacement (VBR) is intended for use in the thoracolumbar spine (T1-L5) for partial or complete replacement (i.e., vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Atlas Spine VBR is also indicated for treating fractures of the thoracic and lumbar spine.

The Atlas Spine VBR is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The interior of the Atlas Spine VBR can be packed with bone. This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

| Prescription Use | X | AND/OR | Over-The-Counter Use | |
|-----------------------------|---|--------|------------------------|--|
| (Part 21 CFR 801 Subpart D) | | | (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)

(Division Sig-Off)

Division of General, Restorative,

and Neurological Devices

| (Posted November 13, 2003) | |
|----------------------------|---------|
| 510(k) Number | K063464 |
| Page | of |