LAURAIN DEWALD ANTERIOR FIXATION SYSTEM

K023797 · Medtronic Sofamor Danek · KWP · Dec 13, 2002 · Orthopedic

Device Facts

• Record ID: K023797
• Device Name: LAURAIN DEWALD ANTERIOR FIXATION SYSTEM
• Applicant: Medtronic Sofamor Danek
• Product Code: KWP · Orthopedic
• Decision Date: Dec 13, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Properly used, the LAURAIN DEWALD™ Anterior Fixation System is intended to provide stabilization during the development of a solid spinal fusion. The specific indications are: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) pseudoarthrosis, (3) spondylolysis, (4) spinal deformation such as kyphosis and lordosis, (5) fracture, (6) unsuccessful previous attempts at spinal surgery, (7) tumor resection, (8) correction of severe instability and/or deformity when used in addition to a posterior spinal instrumentation system, (9) neoplastic disease, and/or (10) deformity associated with deficient posterior elements, such as laminectomy, spina bifida, or myelomeningocele.

Device Story

The LAURAIN DEWALD Anterior Fixation System is a spinal orthosis consisting of plates, screws, nuts, spacers, and staples. It is used by surgeons in an operating room setting to provide mechanical stabilization of the spine during the development of a solid spinal fusion. Components are selected and locked into configurations tailored to the individual patient's anatomy and pathology. The system acts as an internal fixation device to maintain alignment and stability while bone fusion occurs. It is intended for use in various spinal conditions, including degenerative disc disease, fractures, and deformities.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and intended use.

Technological Characteristics

System consists of metallic plates, screws, nuts, spacers, and staples. Mechanical fixation device; no energy source or software components. Sterilization method not specified.

Indications for Use

Indicated for patients requiring spinal stabilization during fusion for degenerative disc disease, pseudoarthrosis, spondylolysis, spinal deformity (kyphosis/lordosis), fracture, failed prior surgery, tumor resection, neoplastic disease, or deformity with deficient posterior elements (laminectomy, spina bifida, myelomeningocele).

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.

Submission Summary (Full Text)

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## LAURAIN DEWALD Anterior Fixation System 510(k) Summary December 2002

DEC 1 3 2002

### I. Company: Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132 [phone]

#### II. Proprietary Trade Name: LAURAIN DEWALD Anterior Fixation System

#### III. Regulation Number: 888.3060 - KWQ

#### IV. Product Description

The LAURAIN DEWALD Anterior Fixation System consists of a variety of shapes and sizes of plates, screws, nuts, spacers and staples, as well as ancillary products and instrument sets. The components can be locked into a variety of configurations, with each construct tailor-made for the individual case.

The purpose of this submission is to include additional plates, screws and staples to the LAURAIN DEWALD Anterior Fixation System.

#### V. Indications

Properly used, the LAURAIN DEWALD™ Anterior Fixation System is intended to provide stabilization during the development of a solid spinal fusion. The specific indications are: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) pseudoarthrosis, (3) spondylolysis, (4) spinal deformation such as kyphosis and lordosis, (5) fracture, (6) unsuccessful previous attempts at spinal surgery, (7) tumor resection, (8) correction of severe instability and/or deformity when used in addition to a posterior spinal instrumentation system, (9) neoplastic disease, and/or (10) deformity associated with deficient posterior elements, such as laminectomy, spina bifida, or myelomeningocele.

#### VI. Substantial Equivalence

Documentation was provided which demonstrated the LAURAIN DEWALD Anterior Fixation System to be substantially equivalent to itself.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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Image /page/1/Picture/2 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized eagle with three stripes extending from its head, representing the department's commitment to health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle symbol.

DEC 13 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K023797

> Trade Name: LAURAIN DEWALD Anterior Fixation System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: KWP Dated: November 13, 2002 Received: November 14, 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, 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 - Richard W. Treharne, Ph.D.

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]. 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/dsmamain.html.

Sincerely yours,

R. Mark A. Millham

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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510(k) Number (if known): K023797 Device Name; LAURAIN DEWALD Anterior Fixation System Indications for Use:

Properly used, the LAURAIN DEWALD™ Anterior Fixation System is intended to provide stabilization during the development of a solid spinal fusion. The specific indications are: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) pseudoarthrosis, (3) spondylolysis, (4) spinal deformation such as kyphosis and lordosis, (5) fracture, (6) unsuccessful previous attempts at spinal surgery, (7) tumor resection, (8) correction of severe instability and/or deformity when used in addition to a posterior spinal instrumentation system, (9) neoplastic disease, and/or (10) deformity associated with deficient posterior elements, such as laminectomy, spina bifida, or myelomeningocele.

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## Concurrence of CDRH, Office of Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) (Optional 1-2-96)

OR

Over-the-counter Use _

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(Division Sign-C Division of Cereval. Elestorative and Neurological ber ices

510(k) Number k033797