DEPUY ACROMED VBR SYSTEM

K030833 · Depuyacromed · MQP · Apr 10, 2003 · Orthopedic

Device Facts

• Record ID: K030833
• Device Name: DEPUY ACROMED VBR SYSTEM
• Applicant: Depuyacromed
• Product Code: MQP · Orthopedic
• Decision Date: Apr 10, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DePuy AcroMed VBR System is indicated for use in the thoracolumbar spine (i.e., T1 to 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 DePuy AcroMed VBR System is also indicated for treating fractures of the thoracic and lumbar spine. The DePuy AcroMed VBR 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 DePuy AcroMed VBR System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the VBR System include DePuy AcroMed titanium plate or rod systems (i.e., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch, and Profile).

Device Story

DePuy AcroMed VBR System is a spinal intervertebral body fixation orthosis; used to replace diseased or fractured vertebral bodies in the thoracolumbar spine (T1-L5). Device acts as a structural spacer to restore vertebral height and biomechanical integrity of the spinal column. Operated by surgeons in an OR setting; requires supplemental internal fixation (e.g., titanium plates or rods). Input is the patient's anatomical defect; output is mechanical stabilization of the spinal column. Benefits include decompression of neural tissues and restoration of spinal column support. This submission introduces additional cage sizes with modified footprints; design maintains functional equivalence to previously cleared systems.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical performance was validated through static testing (Test Report ACRO-0400-01) to ensure the new cage sizes meet or exceed the performance of previously cleared predicate devices.

Technological Characteristics

Material: Carbon-fiber reinforced polymer. Form factor: Stackable cage system with modified footprints. Energy source: None (mechanical implant). Connectivity: None. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for patients requiring vertebral body replacement in the thoracolumbar spine (T1-L5) due to tumor resection or excision, or for treatment of thoracic and lumbar spine 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

• Stackable Cage System (K990148, K001340)
• Surgical Titanium Mesh System (K003043, K020522, K023835, K034209)

Submission Summary (Full Text)

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APR 1 0 2003

K030833

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### IX. 510 (k) Summary

| SUBMITTER: | DePuy AcroMed ^™ , Inc.<br>325 Paramount Drive<br>Raynham, MA 02780 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Karen F. Jurczak |
| DATE PREPARED: | March 13, 2003 |
| CLASSIFICATION NAME: | Implant, Fixation Device<br>Spinal Intervertebral Body Fixation Orthosis Device |
| PROPRIETARY NAME: | DePuy AcroMed VBR System |
| PREDICATE DEVICES: | Stackable Cage System (K990148, K001340)<br>Surgical Titanium Mesh System<br>(K003043, K020522, K023835, K034209) |
| INTENDED USE: | The DePuy AcroMed VBR System is indicated for use in the thoracolumbar spine (i.e., T1 to 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.<br>The DePuy AcroMed VBR System is also indicated for treating fractures of the thoracic and lumbar spine.<br>The DePuy AcroMed VBR 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.<br>The DePuy AcroMed VBR System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the VBR System include DePuy AcroMed 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 |
| DESCRIPTION: | The additional size cages are identical to the previously cleared stackable cages with regards to indications for use, function and material. The design of the cage is slightly different; the footprint of the device has been slightly modified. |

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030833
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### Summary of Design Control Activities VIII.

A Design Risk Analysis was used to assess risk for the additional sizes. This risk analysis was performed in accordance with DePuy AcroMed Design Control and Quality procedures using static testing. The results of this analysis are on file at DePuy AcroMed, Inc.

| Modification | Risk<br>Associated<br>with Change | How Risk is Addressed | Acceptance<br>Criteria |
|----------------------|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Addition of<br>Sizes | New sizes will<br>not have the<br>same<br>mechanical<br>characteristics<br>as the predicate<br>sizes. | By design, these parts are<br>thicker in cross section<br>than the existing devices<br>and are therefore not<br>worst case for the system.<br>The worst case testing for<br>the system has been<br>provided in Test Report<br>ACRO-0400-01. | The proposed<br>device will perform<br>the same as or<br>better than the<br>device previously<br>cleared in<br>K990148 and<br>K001340. |

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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, formed by three human profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 1 0 2003

Mr. Frank Maas Director, Regulatory Affairs DePuy AcroMed 325 Paramount Drive Raynham, Massachusetts 02767-0350

Re: K030833

Trade/Device Name: DePuy AcroMed VBR System Regulation Numbers: 21 CFR 888.3060 Regulation Names: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Codes: MQP Dated: March 14, 2003 Received: March 17, 2003

Dear Mr. Maas:

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. Iisting of devices, good manufacturing practice, labeiing, 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. Frank Maas

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,

Sincerely yours,

Mark A. Mulkeran

Celia M. 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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#### III. Indications for Use

KO30832 510(k) Number (if known): __

Device Name: DePuy AcroMed VBR System

## Indications For Use:

The DePuy AcroMed VBR System is indicated for use in the thoracolumbar spine (i.e., T1 to 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 DePuy AcroMed VBR System is also indicated for treating fractures of the thoracic and lumbar spine.

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

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109) OR Over-The-Counter Use:

Mark N. Millerson

Division Sign-Off storative Division of Cit and Neurological L Vices

510(k) Number .