MODIFICATION TO BONE GRAFT WASHER

K041217 · Medtronic Sofamor Danek, Inc. · KWQ · May 28, 2004 · Orthopedic

Device Facts

• Record ID: K041217
• Device Name: MODIFICATION TO BONE GRAFT WASHER
• Applicant: Medtronic Sofamor Danek, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: May 28, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Each BONE GRAFT WASHER is intended to stabilize the bone graft at one level (T1-S1) as an aid to spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials (e.g., commercially pure titanium or titanium alloy).

Device Story

Bone Graft Washer is a temporary spinal implant designed to prevent bone graft extrusion and provide temporary stabilization to support solid spinal fusion. The system consists of various sizes of washers used in conjunction with a screw. It is intended for use by surgeons in spinal procedures at levels T1-S1. The device may be used as a standalone component or in combination with other anterior, anterolateral, or posterior spinal fixation systems. By securing the bone graft, the washer aids in maintaining graft position during the fusion process, potentially improving clinical outcomes for patients undergoing spinal stabilization surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Implantable washer system; materials include commercially pure titanium or titanium alloy; designed for use with screws; various sizes available for T1-S1 spinal levels.

Indications for Use

Indicated for patients requiring spinal fusion at one level (T1-S1) to stabilize bone graft. Used alone or with compatible anterior, anterolateral, or posterior spinal systems.

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.

Submission Summary (Full Text)

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# BONE GRAFT WASHER 510(k) Summary May 2004

- Medtronic Sofamor Danek I. Company: 1800 Pyramid Place Memphis, TN 38132 [phone]
#### Proprietary Trade Name: BONE GRAFT WASHER II.

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

#### IV. Product Description

The BONE GRAFT WASHER is a temporary implant used to prevent bone graft extrusion. The washer is also intended to provide temporary stabilization and augment development of a solid spinal fusion. The BONE GRAFT WASHER consists of a variety of sizes of washers used with a screw.

The purpose of this submission is to make include modified washers and an additional screw to the system.

#### V. Indications

Each BONE GRAFT WASHER is intended to stabilize the bone graft at one level (T1-S1) as an aid to spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials (c.g., commercially pure titanium or titanium alloy).

#### VI. Substantial Equivalence

Documentation was provided which demonstrated the BONE GRAFT WASHER to be substantially equivalent to itself.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 8 2004

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

Re: K041217

> Trade Name: Bone Graft Washer Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation System Regulatory Class: Class II Product Code: KWO Dated: June 17, 2003 Received: June 18, 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 Codc of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Dr. Rick Treharne

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 (OS) 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/cdrb/dsma/dsmamain.html.

Sincerely yours,

Mark A. Wilkerson

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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### K041217 510(k) Number (if known): BONE GRAFT WASHER Device Name:

## Indications for Use:

Each BONE GRAFT WASHER is intended to stabilize the bone graft at one level (T1-S I ) as an aid to spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials (e.g., commercially pure titanium or titanium alloy).

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Wilkerson

Division of General, Restorative, and Neurological Devices

510(k) Number K041217