MSD CABLE REDUCTION SYSTEM

K030816 · Medtronic Sofamor Danek · KWP · Jun 6, 2003 · Orthopedic

Device Facts

• Record ID: K030816
• Device Name: MSD CABLE REDUCTION SYSTEM
• Applicant: Medtronic Sofamor Danek
• Product Code: KWP · Orthopedic
• Decision Date: Jun 6, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MSD CABLE REDUCTION SYSTEM screws and hooks are only intended for use in the thoracic and lumbar spine. The system provides an alternative to sublaminar and intraspinous process wiring for trauma applications. Another application is the use of the MSD CABLE REDUCTION SYSTEM for instrumentation involved in the correction of scoliotic, kyphotic, and lordotic deformities. The system may also be used with other spinal implants such as the MSD Unit Rod, the ATLAS™ CABLE System or the Luque Rod, or wherever "wiring" may help secure the attachment of other implants.

Device Story

MSD Cable Reduction System is a temporary orthopedic implant system consisting of multi-stranded cables and ancillary components (screws, hooks). Used in thoracic and lumbar spine surgery to provide temporary stabilization, augment bony fusion, or repair bone fractures. Operates as a mechanical fixation device; functions as an alternative to traditional wiring techniques. Used by surgeons in clinical settings to secure spinal implants (e.g., MSD Unit Rod, Luque Rod). Provides structural support to aid in deformity correction and bone healing. Sold sterile or non-sterile.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Medical grade stainless steel (ASTM F-138, ISO 5832-1/9), titanium alloy (ASTM F-136, ISO 5832-3), or pure titanium (ASTM F-67, ISO 5832-2). Mechanical fixation system consisting of multi-stranded cables, screws, and hooks. Non-electronic, non-software device.

Indications for Use

Indicated for patients requiring thoracic or lumbar spine stabilization, trauma repair, or correction of scoliotic, kyphotic, and lordotic deformities. Used as an alternative to sublaminar or intraspinous process wiring.

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

• ATLAS™ CABLE System

Reference Devices

• MSD Unit Rod
• Luque Rod

Submission Summary (Full Text)

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# JUN - 6 2003

## Medtronic Sofamor Danek CABLE REDUCTION SYSTEM 510(k) Summary (K030816) May 2003

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

#### Proposed Proprietary Trade Name: II.

MSD CABLE REDUCTION SYSTEM

Regulation Numbers: 888.3050 and 888.3010

Regulation Names: Bone Fixation Cerclage, Spinal Interlaminal Fixation Orthosis

Codes: KWP, JDQ

#### Description III.

The MSD CABLE REDUCTION SYSTEM is a temporary implant for the use in orthopaedic surgery. The system is intended to help provide temporary stabilization, augment the development of solid bony fusion and/or aid in the repair of bone fractures.

The system consists of a multi-stranded cable and ancillary components used in several different configurations. The MSD CABLE REDUCTION SYSTEM implant components are made of medical grade stainless steel described by ASTM Standard F-138 or ISO 5832-1 or ISO 5832-9. Alternatively, the system may be made out of titanium alloy or titanium, as described in ASTM F-136 or ISO 5832-3 for the surgical grade titanium alloy and ASTM F 67 or ISO 5832-2 for pure titanium. The MSD CABLE REDUCTION SYSTEM may be sold sterile or non-sterile.

#### IV. Indications for Use:

The MSD CABLE REDUCTION SYSTEM screws and hooks are only intended for use in the thoracic and lumbar spine. The system provides an alternative to sublaminar and intraspinous process wiring for trauma applications. Another application is the use of the MSD CABLE REDUCTION SYSTEM for instrumentation involved in the correction of scoliotic, kyphotic, and lordotic deformities. The system may also be used with other

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spinal implants such as the MSD Unit Rod, the ATLAS™ CABLE System or the Luque Rod, or wherever "wiring" may help secure the attachment of other implants.

#### Substantial Equivalence: V.

The subject MSD CABLE REDUCTION SYSTEM components were declared substantially equivalent to the predicate ATLAS™ CABLE System components manufactured by Medtronic Sofamor Danek.

© 2003 Medtronic Sofamor Danek

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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 emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human profile, represented by three curved lines that suggest a face looking to the right. The logo is rendered in black and white.

Public Health Service

JUN - 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K030816

> Trade Name: MSD Cable Reduction System Regulation Number: 21 CFR 888.3050, 888.3010 Regulation Name: Spinal interlaminal fixation orthosis, Bone fixation cerclage Regulatory Class: II Product Code: KWP, JDQ Dated: April 21, 2003 Received: April 22, 2003

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 - Dr. Richard 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]. 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,

Miriam C. Provost

O 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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510(k) Number (if known): ____K030816

Device Name: _ _ _____________________________________________________________________________________________________________________________________________________________

The MSD CABLE REDUCTION SYSTEM screws and hooks are only intended for use in the thoracic and lumbar spine. The system provides an alternative to sublaminar and intraspinous process wiring for trauma applications. Another application is the use of the MSD CABLE REDUCTION SYSTEM for instrumentation involved in the correction of scoliotic, and lordotic deformities. The system may also be used with other spinal implants such as the MSD Unit Rod, the ATLAS™ CABLE System or the Luque Rod, or wherever "wiring" may help secure the attachment of other implants.

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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 - -

Muriam C. Provost

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

510(k) Number K030816