XANTUS ANTERIOR LATERAL SUPPLEMENTAL FIXATION SYSTEM

K022070 · Medtronic Sofamor Danek, Inc. · KWP · Jul 22, 2002 · Orthopedic

Device Facts

• Record ID: K022070
• Device Name: XANTUS ANTERIOR LATERAL SUPPLEMENTAL FIXATION SYSTEM
• Applicant: Medtronic Sofamor Danek, Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Jul 22, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The XANTUSTM Anterior Lateral Supplemental Fixation System is intended for screw/bolt fixation/attachment to the anterolateral intervertebral bodies from T1 to L5 only. This system is to be used only on one side and placed in such a manner as to be as far away from blood vessels such as the aorta and nerve roots as possible. When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1. Degenerative Disc Disease (DDD as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). 2. Pseudoarthrosis. 3. Spondylolysis. 4. Spondylolisthesis. 5. Fracture. 6. Neoplastic disease. 7. Unsuccessful previous fusion surgery. 8. Lordotic deformities of the spine. 9. Idiopathic thoracolumbar or lumbar scoliosis. 10. Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele. 11. Neuromuscular deformity (i.e., scoliosis, and/or kyphosis) associated with pelvic obliquity.

Device Story

System consists of plates, screws, bolts, and nuts for anterolateral intervertebral body fixation; provides temporary stabilization to facilitate spinal fusion. Used in orthopedic/neurosurgical procedures; implanted by surgeons. Components can be configured for individual patient anatomy; compatible with other Medtronic spinal system components (ZPLATE-ATL screws, DYNA-LOK nuts). System is placed unilaterally, avoiding aorta and nerve roots. Benefits include structural support during fusion process.

Clinical Evidence

No clinical data. Substantial equivalence based on bench testing and design comparison to predicate.

Technological Characteristics

Spinal intervertebral body fixation orthosis; metallic plates, screws, bolts, and nuts. Modular configuration; unilateral placement. Mechanical fixation principle. No software or electronic components.

Indications for Use

Indicated for patients requiring temporary spinal stabilization (T1-L5) for degenerative disc disease, pseudoarthrosis, spondylolysis, spondylolisthesis, fractures, neoplastic disease, failed fusion, lordotic deformities, idiopathic scoliosis, deformities with deficient posterior elements, or neuromuscular deformity with pelvic obliquity.

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

• XANTUS Anterior Lateral Supplemental Fixation System (K014267)

Reference Devices

• ZPLATE-ATL Anterior Fixation System
• DYNA-LOK Spinal System

Submission Summary (Full Text)

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K022070 1/2

# JUL 2 2 2002

## Medtronic Sofamor Danek XANTUS™Anterior Lateral Supplemental Fixation System 510(k) Summary June 2002

| Submitter: | Medtronic Sofamor Danek USA, Inc.<br>1800 Pyramid Place<br>Memphis, TN 38132 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Richard Treharne |
| Trade Name: | XANTUSTM Anterior Lateral Supplemental Fixation System |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis, Class II |
| Predicate Device(s): | The XANTUSTM Anterior Lateral Supplemental Fixation System<br>is substantially equivalent to K014267, Medtronic Sofamor Danek<br>XANTUSTM Anterior Lateral Supplemental Fixation System, which was<br>cleared on January 25, 2002. |
| Device Description: | The XANTUSTM Anterior Lateral Supplemental Fixation System consists of a<br>variety of shapes and sizes of plates, screws, bolts, and nuts, as well as<br>ancillary products and instrument sets. XANTUSTM Anterior Lateral<br>Supplemental Fixation System anterior implant components can be locked into<br>a variety of configurations, with each construct being tailor-made for the<br>individual case. Implant components from other previously cleared Medtronic<br>Sofamor Danek Spinal Systems can be used in conjunction with XANTUSTM<br>Anterior Lateral Supplemental Fixation System. These components include the<br>ZPLATE-ATL™ Anterior Fixation System screws and the DYNA-LOK®<br>Spinal System nut. Refer to those package inserts for proper specific<br>instructions for use. |
| Intended Use: | |

The XANTUSTM Anterior Lateral Supplemental Fixation System is intended for screw/bolt fixation/attachment to the anterolateral intervertebral bodies from T1 to L5 only. This system is to be used only on one side and placed in such a manner as to be as far away from blood vessels such as the aorta and nerve roots as possible.

When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. Specific indications include:

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1. Degenerative Disc Disease (DDD as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). 2. Pseudoarthrosis. 3. Spondylolysis. 4. Spondylolisthesis. 5. Fracture. 6. Neoplastic disease. Unsuccessful previous fusion surgery. 7. 8. Lordotic deformities of the spine. Idiopathic thoracolumbar or lumbar scoliosis. 9. Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with 10. deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele. Neuromuscular deformity (i.e., scoliosis, and/or kyphosis) 11. associated with pelvic obliquity. Functionality & Mechanical testing was performed on the Subject XANTUS™ Anterior Lateral Safety Testing: Supplemental Fixation System which determined it to be substantially equivalent to the predicate XANTUS™ Anterior Lateral Supplemental Fixation System. The XANTUS™ Anterior Lateral Supplemental Fixation System is Conclusion: substantially equivalent to K014267, the XANTUSTM Anterior Lateral Supplemental Fixation System .

KO22070p%

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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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing right, with flowing lines above them that resemble wings or ribbons.

JUL 2 2 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Richard W. Treharne, Ph.D. Senior Vice President, Research and Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132

K022070 Re:

> Trade/Device Name: XANTUS™ Anterior Lateral Supplemental Fixation System Regulatory Number: 21 CFR 888.3050 Regulation Name: Spinal Interlaminal Fixation Orthosis Regulatory Class: II Product Code: KWP, MNH Dated: June 18, 2002 Received: June 26, 2002

Dear Dr. Treharne:

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, 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 –

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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### K622670 510(k) Number (if known): _

### Device Name: XANTUS™ Anterior Lateral Supplemental Fixation System

#### Indications for Use:

The XANTUSTM Anterior Lateral Supplemental Fixation System is intended for screw/bolt fixation/attachment to the anterolateral intervertebral bodies from T1 to L5 only. This system is to be used only on one side and placed in such a manner as to be as far away from blood vessels such as the aorta and nerve roots as possible.

When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. Specific indications include:

- Degenerative Disc Disease (DDD as defined as back pain of discogenic origin with degeneration 1. of the disc confirmed by history and radiographic studies).
- 2. Pseudoarthrosis.
- 3. Spondylolysis.
- 4. Spondylolisthesis.
- న. Fracture.
- 6. Neoplastic disease.
- 7. Unsuccessful previous fusion surgery.
- 8. Lordotic deformities of the spine.
- 9. Idiopathic thoracolumbar or lumbar scoliosis.
- 10. Deformity (i.e., scoliosis, lordosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele.
- 11. Neuromuscular deformity (i.e., scoliosis, and/or kyphosis) associated with pelvic obliquity.

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

Concurrence of CDRH, Office of Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

510(k) Number K022070 K022070

Prescription Use OR Over-the-counter Use
(Per 21 CFR 801.109)
(Optional 1-2-96)