CONCORDE VBR SPINAL SYSTEM

K052746 · Depuy Spine, Inc. · MQP · Oct 21, 2005 · Orthopedic

Device Facts

• Record ID: K052746
• Device Name: CONCORDE VBR SPINAL SYSTEM
• Applicant: Depuy Spine, Inc.
• Product Code: MQP · Orthopedic
• Decision Date: Oct 21, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Concorde VBR Spinal System is indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Concorde VBR Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The Concorde VBR Spinal System 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. The Concorde VBR Spinal System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Concorde VBR Spinal System include DePuy Spine titanium plate or rod systems (i.e., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, T MX, MONARCH, Expedium, Viper, and Profile).

Device Story

Concorde VBR Spinal System is a vertebral body replacement device; used to restore biomechanical integrity of the spinal column following tumor resection or fracture. Device replaces diseased vertebral bodies; restores height; provides anterior decompression. System comprises various sizes and footprints; constructed from carbon-fiber reinforced polymer. Intended for use in the thoracolumbar spine (T1-L5); requires supplemental internal fixation (e.g., titanium plate or rod systems). Used by surgeons in clinical settings to stabilize the spine; benefits patients by restoring structural support and spinal column integrity.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Vertebral body replacement device; carbon-fiber reinforced polymer construction. Designed for thoracolumbar (T1-L5) application. Requires supplemental internal fixation via titanium plate or rod systems. Manual surgical instruments included.

Indications for Use

Indicated for patients requiring vertebral body replacement in the thoracolumbar spine (T1-L5) due to tumor resection/excision or fractures. Used to achieve anterior decompression and restore vertebral height. Requires use with supplemental internal fixation.

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

• Concorde VBR Spinal System (K041722)

Reference Devices

• Kaneda SR
• University Plate
• M-2
• ISOLA
• VSP
• Moss Miami
• T MX
• MONARCH
• Expedium
• Viper
• Profile

Submission Summary (Full Text)

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

- OCT 2 1 2005 510(k) Summary IX. SUBMITTER: DePuv Spine, Inc. 325 Paramount Drive Raynham, MA 02780 CONTACT PERSON: Lisa A. Gilman DATE PREPARED: September 29, 2005 CLASSIFICATION NAME: Implant, Fixation Device Spinal Intervertebral Body Fixation Orthosis Device Concorde VBR Spinal System PROPRIETARY NAME: VBR Spinal System (K041722) PREDICATE DEVICES: DEVICE DESCRIPTION: Additional components in various sizes and footprints alternative minimally invasive surgical and an approach. The Concorde VBR Spinal System also contains Class 1 manual surqical instruments and cases that are considered exempt from premarket notification. The Concorde VBR Spinal System is indicated for use INTENDED USE: in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Concorde VBR Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The Concorde VBR Spinal System 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. The Concorde VBR Spinal System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the

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

Concorde VBR Spinal System

Concorde VBR Spinal System include DePuy Spine titanium plate or rod systems (i.e., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, T MX, MONARCH, Expedium, Viper, and Profile).

Carbon-fiber reinforced polymer MATERIALS:

PERFORMANCE DATA:

Performance data were submitted to characterize the additional components of the Concorde VBR Spinal System.

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

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract image of an eagle with three stylized feathers. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

OCT 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sharon Starowicz Director, Regulatory Affairs DePuy Spine, Inc. 325 Paramount Drive Raynham, Massachusetts 02767

Re: K052746

Trade/Device Name: Concorde VBR Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: September 29, 2005 Received: September 30, 2005

Dear Ms. Starowicz:

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- Sharon Starowicz

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with and w yourse of substantial equivalence of your device to a legally premaince notification - Theseification 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 rr you desire specific acreoliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain Whisoranding of Terefore to presessonsibilities under the Act from the Division of Small other golferal miorinational 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,

Mark Naff

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

Enclosure

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

## lll. Indications for Use

| 510(k) Number (if known): | K052746 |
|---------------------------|---------|
|---------------------------|---------|

Concorde VBR Spinal System Device Name:

Indications For Use:

The Concorde VBR Spinal System is indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.

The Concorde VBR Spinal System is also indicated for treating fractures of the thoracic and lumbar spine.

The Concorde VBR Spinal System 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.

The Concorde VBR Spinal System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the VBR Spinal System include DePuy Spine titanium plate or rod systems (i.e., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, MONARCH, Expedium. Viper, and Profile).

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

s

(Division Sign-Off) Division of General. Restorative. and Neurological Devices

510(k) Number_K0522344