KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW

K030368 · KARL STORZ Endoscopy-America, Inc. · HWC · Mar 20, 2003 · Orthopedic

Device Facts

• Record ID: K030368
• Device Name: KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Mar 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MegaFix-T™ Titanium Interference Screw is intended for tibial and femoral fixation (primary anchorage) of tendon grafts in anterior and posterior cruciate ligament reconstruction.

Device Story

The MegaFix-T™ is a titanium interference screw used for primary anchorage of tendon grafts during anterior and posterior cruciate ligament (ACL/PCL) reconstruction. The device is implanted by a surgeon in an operating room setting to secure the graft within the bone tunnel. It functions as a mechanical fixation fastener. The use of titanium provides biocompatibility for long-term implantation. The device benefits the patient by providing stable fixation of the graft, facilitating proper healing and ligament reconstruction.

Clinical Evidence

No clinical data provided; substantial equivalence is based on device design and material biocompatibility.

Technological Characteristics

Material: Titanium. Form factor: Interference screw. Function: Smooth or threaded metallic bone fixation fastener. Regulatory class: II. Product code: HWC.

Indications for Use

Indicated for tibial and femoral fixation (primary anchorage) of tendon grafts in anterior and posterior cruciate ligament reconstruction.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a logo for "STORZ". The logo is in white against a black background. The letter "O" in the logo is replaced by a black circle with a smaller white circle inside. Below the main logo, there is smaller text that reads "Karl Storz Endoscopy".

Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe 5th Floor Culver City, California 90230-7600 Phone [phone]

Toll Free 800 421 0837 Fax [phone]

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.

| Applicant: | Karl Storz Endoscopy - America, Inc.<br>600 Corporate Pointe Drive<br>Culver City, CA 90230<br>[phone] | MAR 20 2003 |
|------------------------|---------------------------------------------------------------------------------------------------------------|-------------|
| Contact: | Mario T. Marcelo<br>Regulatory Affairs Associate | |
| Device Identification: | Common Name:<br>Cannulated Titanium Interference Screw | |
| | Trade Name: (optional)<br>Karl Storz MegaFix TTM Titanium Interference Screw | |

Indication: The MegaFix-T™ Titanium Interference Screw is intended for tibial and femoral fixation (primary anchorage) of tendon grafts in anterior and posterior cruciate ligament reconstruction.

Device Description: The MegaFix-T™ is composed of titanium, which is commonly used in medical devices for a wide range of application and has a long history of biocompatibility for human use.

Substantial Equivalence: The MegaFix-T™ is substantially equivalent to the predicate devices since the basic features and intended use are similar. The minor differences between the MegaFix-TTM and the predicate devices raise no new issues of safety and effectiveness, as these minor differences have no effect on the performance, function or intended use of the device.

Signed:

Mario T. Marcelo Regulatory Affairs Associate

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2003

Mr. Mario T. Marcelo Regulatory Affairs Associate Karl Storz Endoscopy America, Inc 600 Corporate Pointe 5th Floor Culver City, CA 90230-7600

Re: K030368

Trade/Device Name: Karl Storz MegaFix-T™ Titanium Interference Screw Regulation Number: 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: January 31, 2003 Received: February 4, 2003

Dear Mr. Marcelo:

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 - Mr. Mario T. Marcelo

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,

Sincerely, yours,

Mark N. Mulhern

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): Not yet assigned

Device Name: Karl Storz MegaFix-T™ Titanium Interference Screw

Indications for Use: The MegaFix-T™ Titanium Interference Screw is intended for tibial and femoral fixation (primary anchorage) of tendon grafts in anterior and posterior cruciate ligament reconstruction.

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Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use: OR Over-The Counter Use: (Per 21 CFR 801.109) (Optional Format 1-2-96) 003 10(k) Number