EXPEDIUM ANTERIOR SPINE SYSTEM

K041205 · Depuy Spine, Inc. · KWQ · Aug 17, 2004 · Orthopedic

Device Facts

• Record ID: K041205
• Device Name: EXPEDIUM ANTERIOR SPINE SYSTEM
• Applicant: Depuy Spine, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Aug 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Expedium™ Anterior Spine System is intended for anterolateral screw fixation to the T4 to L4 levels of the spine, with all metal at least 1 cm from a major vessel. The Expedium Anterior Spine System may be used in either thoracoscopic procedures or open procedures.

Device Story

Expedium Anterior Spine System is a spinal intervertebral body fixation orthosis; consists of spinal rods, monoaxial screws, staples, washers, and cross connectors. Designed for anterolateral screw fixation at T4-L4 spinal levels. Used in either open or thoracoscopic surgical procedures by surgeons. Implants provide structural stabilization of the spine to treat various pathologies including degenerative disc disease, trauma, and deformities. Metal components must be placed at least 1 cm from major vessels. System provides mechanical support to facilitate fusion or stabilization.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manufactured from ASTM F-136 implant grade titanium alloy. System components include spinal rods, monoaxial screws, staples, washers, and cross connectors. Designed for anterolateral fixation. Mechanical fixation device; no energy source or software.

Indications for Use

Indicated for patients requiring spinal fixation for degenerative disc disease (discogenic back pain confirmed by history/radiography), spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumor, pseudarthrosis, or previous failed fusion.

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

• Frontier Anterior Scoliosis System (K012916)

Submission Summary (Full Text)

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AUG 1 7 2004

- X. 510(k) Summary
K04/1205
page 1 of 1

- DePuy Spine, Inc. SUBMITTER: 325 Paramount Drive Raynham, MA 02780
- CONTACT PERSON: Jennifer Mooney
- DATE PREPARED: April 29, 2004
- Spinal Intervertebral Body Fixation Orthosis CLASSIFICATION NAME:
- Expedium™ Anterior Spine System PROPRIETARY NAME:
- Frontier Anterior Scoliosis System (K012916) PREDICATE DEVICES:
- DEVICE DESCRIPTION: The Expedium Anterior Spine System consists of spinal rods, monoaxial screws, staples, washers, and cross connectors. The implants of the Expedium Anterior Spine System have been designed for use in either open or thoracoscopic approaches.
- The Expedium Anterior Spine System is intended for anterolateral screw INTENDED USE: fixation to the T4 to L4 levels of the spine, with all metal at least 1 cm from a major vessel. The Expedium Anterior Spine System may be used in either thoracoscopic procedures or open procedures.

The Expedium Anterior Spine System is indicated for:

1. degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies

- 2. spondylolisthesis
- 3. trauma (i.e., fracture or distocation)
- 4. spinal stenosis
- 5. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- 6. tumor
- 7. pseudarthrosis
- 8. previous failed fusion

Manufactured from ASTM F-136 implant grade titanium MATERIALS: allov. PERFORMANCE DATA: Performance data were submitted to characterize the

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 7 2004

Jennifer Mooney Regulatory Affairs Associate DePuy Spine, Inc. 325 Paramount Drive Raynham, Massachusetts 02767

Re: K041205

Trade/Device Name: Expedium™ Anterior Spine System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: August 4, 2004 Received: August 5, 2004

Dear Ms. Mooney:

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). and Ooomether fore, 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 - Jennifer Mooney

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and in your he FDA finding of substantial equivalence of your device to a legally premated 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 rryou desire specific as not any and [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 other general information on Jour Corpomer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Stip A. Rhodes

Celia M. Witten, Ph.D., M.D.

elia 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 IV.

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Expedium™ Anterior Spine System Device Name:

## Indications For Use:

The Expedium™ Anterior Spine System is intended for anterolateral screw fixation to the T4 to L4 levels of the spine, with all metal at least 1 cm from a major vessel. The T = to = Hoven of the System may be used in either thoracoscopic procedures or open procedures.

The Expedium Anterior Spine System is indicated for:

1. degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies

- 2. spondylolisthesis
- 3. trauma (i.e., fracture or dislocation)
- 4. spinal stenosis
- 5. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- 6. tumor
- 7. pseudarthrosis
- 8. previous failed fusion

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS I.INE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative,

and Neurological Devices

| | <img alt="Signature" src="signature.png"/> |
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| 510(k) Number | K041205 |
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| DePuy Spine, Inc. | Page 7 |
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| 510K | |