MODIFICATION TO VBR SPINAL SYSTEM

K041722 · Depuy Spine, Inc. · MQP · Sep 23, 2004 · Orthopedic

Device Facts

• Record ID: K041722
• Device Name: MODIFICATION TO VBR SPINAL SYSTEM
• Applicant: Depuy Spine, Inc.
• Product Code: MQP · Orthopedic
• Decision Date: Sep 23, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

VBR Spinal System consists of implantable components designed to replace diseased or fractured vertebral bodies in the thoracolumbar spine (T1-L5). Device restores vertebral height and biomechanical integrity of spinal column; requires use with supplemental internal fixation (titanium plate or rod systems). Used by surgeons in clinical/OR settings to treat tumors or fractures. Benefits include spinal decompression and structural support. Device components are manufactured from carbon-fiber reinforced polymer.

Clinical Evidence

Bench testing only.

Technological Characteristics

Carbon-fiber reinforced polymer construction. Spinal intervertebral body fixation orthosis. Designed for use with supplemental titanium internal fixation systems. Class II device.

Indications for Use

Indicated for patients with diseased vertebral bodies (resected/excised due to tumors) or fractures in the thoracolumbar spine (T1-L5). Used to restore vertebral height and achieve anterior decompression of spinal cord/neural tissues. 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

• DePuv AcroMed VBR System (K030833)
• DePuv AcroMed VBR System (K031635)
• Stackable Cage System (K990148)
• Surgical Titanium Mesh System (K020522)
• Devex Mesh System (K023835)

Submission Summary (Full Text)

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SEP 2 3 2004

K 641722

## IX. 510(k) Summary

SUBMITTER: DePuv Spine, Inc. 325 Paramount Drive Raynham, MA 02780

Lisa A. Gilman CONTACT PERSON:

June 18, 2004 DATE PREPARED:

CLASSIFICATION NAME: Implant, Fixation Device Spinal Intervertebral Body Fixation Orthosis Device

VBR Spinal System PROPRIETARY NAME:

- DePuv AcroMed VBR System (K030833) PREDICATE DEVICES: DePuv AcroMed VBR System (K031635) Stackable Cage System (K990148) Surgical Titanium Mesh System (K020522) Devex Mesh System (K023835)
- DEVICE DESCRIPTION: Additional components in various sizes and footprints.

The VBR Spinal System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

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

The 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.

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The 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, and Profile).

## MATERIALS: Carbon-fiber reinforced polymer

PERFORMANCE DATA:

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

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SEP 2 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lisa Gilman Regulatory Affairs Associate Depuy Spine, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350

Re: K041722

Trade/Device Name: VBR Spinal System Regulatory Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: August 23, 2004 Received: August 24, 2004

Dear Ms. Gilman:

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 - Ms. Lisa Gilman

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 [phone]. 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/dsma/dsmamain.html

Sincerely yours,

Mark A. Millman

Celia Witten, Ph.D., M.D. 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): ূK041722

Device Name: VBR Spinal System

Indications For Use:

The indications for use for the modified devices described in this submission are the same as those for the DePuy AcroMed VBR System. The indications are as follows:

The 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 a nerior decompression of the spinal cord and neural tissues, and to restore the height nf a allensed vertebral body.

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

The 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 pneriod.

The 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, II SULA, VSP, Moss Miami, TiMX, MONARCH, and Profile).

Prescription Use X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Millheuser

Division Sign-Off

neral. Restorative. and Neurological Devices

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**510(k) Number** K041722