EXPEDIUM SPINE SYSTEM

K041119 · Depuy Spine, Inc. · KWP · Jul 19, 2004 · Orthopedic

Device Facts

• Record ID: K041119
• Device Name: EXPEDIUM SPINE SYSTEM
• Applicant: Depuy Spine, Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Jul 19, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Expedium Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

Device Story

Expedium Spine System consists of spinal fixation components designed to accept 5.5mm rods; available in various geometries and sizes. Used by surgeons in clinical settings for spinal stabilization. System provides mechanical support to the spine to facilitate fusion or correction of deformities. Components are implanted during surgical procedures to address specific spinal pathologies. System includes manual surgical instruments and cases. Benefits include stabilization of spinal segments in patients with degenerative or traumatic conditions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: ASTM F-138 and F-1314 implant grade stainless steel; ASTM F-136 implant grade titanium alloy. Components designed for 5.5mm rod fixation. Mechanical spinal fixation system.

Indications for Use

Indicated for skeletally mature patients requiring noncervical pedicle or nonpedicle spinal fixation for degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, spinal curvatures (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• Expedium Spine System (Merlin Spine System) (k033901)

Submission Summary (Full Text)

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| IX. 510(k) Summary | K041119 | JUL 1 9 2004 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| SUBMITTER: | DePuy Spine, Inc.<br>325 Paramount Drive<br>Raynham, MA 02780 | |
| CONTACT PERSON: | Jennifer Mooney | |
| DATE PREPARED: | April 26, 2004 | |
| CLASSIFICATION NAME: | Appliance, Fixation, Spinal Interlaminal<br>Orthosis, Spinal Pedicle Fixation, Spinal Intervertebral<br>Body Fixation | |
| PROPRIETARY NAME: | Expedium Spine System | |
| PREDICATE DEVICES: | Expedium Spine System (Merlin Spine System)<br>k033901 | |
| DEVICE DESCRIPTION: | Expedium Spine System components are designed to<br>accept a 5.5mm rod and are available in various<br>geometries and sizes.<br><br>The Expedium Spine System also contains Class 1<br>manual surgical instruments and cases that are<br>considered exempt from premarket notification | |
| INTENDED USE: | The Expedium Spine System is intended for<br>noncervical pedicle fixation and nonpedicle fixation for<br>the following indications: degenerative disc disease<br>(defined as back pain of discogenic origin with<br>degeneration of the disc confirmed by history and<br>radiographic studies); spondylolisthesis; trauma (i.e.,<br>fracture or dislocation); spinal stenosis; curvatures<br>(i.e., scoliosis, kyphosis, and/or lordosis); tumor;<br>pseudoarthrosis; and failed previous fusion in<br>skeletally mature patients. | |
| MATERIALS: | Manufactured from ASTM F-138 and F-1314 implant<br>grade stainless steel and ASTM F-136 implant grade<br>titanium alloy. | |
| PERFORMANCE<br>DATA: | Performance data were submitted to characterize the<br>additonal Expedium Spine System components. | |

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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a symbol that looks like three stylized human figures connected at the shoulders. The symbol is black and the background is white.

Public Health Service

JUL 1 9 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K04119

Trade/Device Name: Expedium Spine System Regulation Number: 21 CFR 888.3050; 21 CFR 888.3060; 21 CFR 888.3070 Regulation Name: Spinal interlaminar fixation orthosis, Spinal intervertebral body fixation orthosis, Pedicle screw spinal system Regulatory Class: II Product Code: KWP, MNH, MNI, NKB, KWQ Dated: June 25, 2004 Received: June 28, 2004

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

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Page 2 - Ms. Sharon Starowicz

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. 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,

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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## Indications for Use lll.

04/119 510(k) Number (if known): J

Expedium™ Spine System Device Name:

Indications For Use:

The Expedium™ Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

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

Over-The-Counter Use (21 CFR 8C7 Subpart C)

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

Concurrence of CDRH, Office ral. Restorative, and Neurological Devices DePuy Spine, Inc. Page 5 Special 510K