X-MESH EXPANDABLE CAGE SYSTEM

K080568 · Depuy Spine, Inc. · MQP · May 1, 2008 · Orthopedic

Device Facts

• Record ID: K080568
• Device Name: X-MESH EXPANDABLE CAGE SYSTEM
• Applicant: Depuy Spine, Inc.
• Product Code: MQP · Orthopedic
• Decision Date: May 1, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The X-MESH™ Expandable Cage 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 X-MESH™ Expandable Cage System is also indicated for treating fractures of the thoracic and lumbar spine. The X-MESH™ Expandable Cage 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 X-MESH™ Expandable Cage System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used include titanium plate or rod systems (i.e., KANEDA™ SR, UNIVERSITY PLATE™, M-2 ANTERIOR PLATE™, ISOLA®, VSP®, MOSS®MIAMI, TIMX™, MONARCH™, EXPEDIUM™, VIPER™, PROFILE™).

Device Story

X-MESH Expandable Cage System is a spinal vertebral body replacement device. It features three approach-specific shapes (anterior lateral, direct anterior, posterior) with rough, convex endplates and spikes for anchoring to resist migration and rotation. The cage includes diamond-pattern side slots and large graft windows for bone graft material. It is axially expandable and includes a setscrew for locking the expanded position. The device is implanted by a surgeon to replace diseased or fractured vertebral bodies in the thoracolumbar spine. It functions to restore biomechanical integrity of the spinal column and must be used in conjunction with supplemental internal fixation systems (e.g., titanium plates or rods).

Clinical Evidence

Bench testing only. Performance data were submitted to characterize the device's biomechanical integrity and functional performance.

Technological Characteristics

Manufactured from ASTM F 136 implant grade titanium alloy. Features an axially expandable cage design with a setscrew locking mechanism, rough convex endplates with spikes, and graft windows. Designed for anterior, anterior-lateral, or posterior surgical approaches in the thoracolumbar spine.

Indications for Use

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

• Surgical Titanium Mesh (K030249)
• Stackable Cage System (K013382)

Reference Devices

• KANEDA™ SR
• UNIVERSITY PLATE™
• M-2 ANTERIOR PLATE™
• ISOLA®
• VSP®
• MOSS®MIAMI
• TiMX™
• MONARCH™
• EXPEDIUM™
• VIPER™
• PROFILE™

Submission Summary (Full Text)

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K080568

## 510(K) SUMMARY 6.

MAY - 1 2008

| <b>Submitter:</b> | DePuy Spine, Inc. |
|-------------------|---------------------|
| | 325 Paramount Drive |
| | Raynham, MA 02767 |

| Contact Person: | Hande Tufan<br>Senior Regulatory Affairs Associate |
|-----------------|----------------------------------------------------|
| Voice: | 508-828-3065 |
| Fax: | [phone] |
| E-Mail: | [e-mail] |

February 28, 2008 Date Prepared:

Device Class: Class П

Classification Name: Spinal Vertebral Body Replacement Device

Classification Panel: Orthopedics

FDA Panel Number: 87

| Product Code(s): | MQP |
|--------------------|---------------------------------------------------------------------|
| Proprietary Name: | X-MESHTM Expandable Cage System |
| Predicate Devices: | Surgical Titanium Mesh (K030249)<br>Stackable Cage System (K013382) |

Device Description: The X-MESH™ Expandable Cage System comes in three approach-specific shapes for the anterior lateral, direct anterior and posterior approaches. Each cage comes fully assembled with rough, convex endplates containing spikes that help anchor the device in the vertebral endplates, and provide resistance to migration and rotation. This mesh cage contains diamond pattern, side slots and large graft windows for graft material. The cage can be expanded axially and has a setscrew for locking it in position.

- The X-MESH™ Expandable Cage System is indicated for Intended Use: 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.
Doep

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080568

The X-MESHT™ Expandable Cage System is also indicated
for treating fractures of the thoracic and lumbar spine.

The X-MESHT™ Expandable Cage 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 X-MESHT™ Expandable Cage System is intended for
use with supplemental internal fixation. The supplemental
internal fixation systems that may be used include titanium
plate or rod systems (i.e., KANEDATM SR, UNIVERSITY
PLATETM, M-2 ANTERIOR PLATET™, ISOLA®, VSP®,
MOSS®MIAMI, TIMXTM, MONARCHTM, EXPEDIUMTM,
VIPERTM, PROFILETM).

**Materials:** Manufactured from ASTM F 136 implant grade titanium
alloy.

**Performance Data:** Performance data were submitted to characterize the
subject X-MESHT™ Expandable Cage System.

DePuy Spine, Inc., a Johnson & Johnson Company

2 82

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 1 2008

DePuy Spine, Inc. % Mr. Hande Tufan Senior Regulatory Affairs Associate 325 Paramount Drive Raynham, MA 02767

Re: K080568 Trade/Device Name: X-MESH™ Expandable Cage System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: April 2, 2008 Received: April 3, 2008

Dear Mr. Tufan:

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. Hande Tufan

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 Millman

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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## KOXOS68

## న. INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: X-MESHTM Expandable Cage System

Indications For Use:

The X-MESH™ Expandable Cage 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 X-MESH™ Expandable Cage System is also indicated for treating fractures of the thoracic and lumbar spine.

The X-MESH™ Expandable Cage 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 X-MESH™ Expandable Cage System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used include titanium plate or rod systems (i.e., KANEDA™ SR, UNIVERSITY PLATE™ M-2 ANTERIOR PLATE™ . ISOLA® . VSP®, MOSS®MIAMI, TiMX™, MONARCH™ EXPEDIUM™, VIPER™, and PROFILE™).

Prescription Use X (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) | |
|------------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of General, Restorative, and Neurological Devices | |
| DePuy Spine, Inc., a Johnson & Johnson Company | |
| 510(k) Number | K080568 |

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