ENDOTACK

K022853 · KARL STORZ Endoscopy-America, Inc. · MBI · Nov 25, 2002 · Orthopedic

Device Facts

• Record ID: K022853
• Device Name: ENDOTACK
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Nov 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Endotack is intended for use to provide tibial fixation for surgical correction of cruciate ligament ruptures as well as for cruciate ligament implant replacement.

Device Story

Endotack is a button fixation device used for tibial fixation in cruciate ligament repair or replacement surgery. Constructed from titanium, the device provides mechanical anchoring for ligaments. It is intended for use by surgeons in an operating room setting. The device functions as a physical fastener to secure tissue or implants, aiding in the stabilization of the knee joint during the healing process.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Titanium. Form factor: Button fixation device. Principle: Mechanical fixation for soft tissue/ligaments. Class II device (21 CFR 888.3040).

Indications for Use

Indicated for patients requiring tibial fixation during surgical correction of cruciate ligament ruptures or cruciate ligament implant replacement.

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)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a logo with the word "SO" in large, stylized letters above the word "Corporation" in smaller letters. The "O" in "SO" is represented by a solid black circle. The image has a grainy, high-contrast appearance, which may be due to the image quality or the original design of the logo.

## A NID SER DE FOR THE BASE BA BE BA BE BE BE

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 KSSM's knowledge.

| Applicant: | Karl Storz Sports Medicine<br>81 West Street<br>Attleboro, MA 02703 | K022853<br>Page 1 of |
|------------------------|-------------------------------------------------------------------------------|----------------------|
| Contact: | James A. Lee, Ph.D.<br>Senior Regulatory Affairs Specialist<br>[phone] | NOV 2 5 2002 |
| Device Identification: | Common Name:<br>Suture anchor | |
| | Trade Name: (optional)<br>Endotack | |

Indication: The Endotack is intended for use to provide tibial fixation for surgical correction of cruciate ligament ruptures.

The Endotack is a button fixation device. The body contact Device Description: portions of the Endotack are composed of titanium, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.

Substantial Equivalence: The Endotack is substantially equivalent to the predicate device since the basic features and intended uses are the similar. The minor difference between the Endotack and the predicate device raises no new issues of safety and effectiveness, as this difference has no effect on the performance, function or intended use of these devices.

Signed:

:

James A. Lee, Ph.D. Senior Regulatory Affairs Specialist

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is arranged on a single line, with each word clearly separated. The overall impression is clean and straightforward, suggesting an official or institutional context.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

James A. Lee, Ph.D. Senior Regulatory Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe, 5th Floor Culver City, California 90230-7600

Re: K022853

Trade/Device Name: Endotack Regulation Number: 21 CFR 888.3040 Regulation Name: Fastener, fixation, nondegradable, soft tissue Regulatory Class: Class II Product Code: MBI Dated: August 22, 2002 Received: August 27, 2002

Dear Dr. Lee:

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. Isting 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.

Image /page/1/Picture/11 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

{2}------------------------------------------------

Page 2 -- Dr. James A. Lee -

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" (21 CFR 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.

sincerely yours,

Ro Mark N Melhurn

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

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo is in black and white and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "Karl Storz Endoscopy" in a smaller font. The logo is simple and clean, and it is likely used to identify the company and its products.

## 510(k) Number (if known): K022853

Device Name: Endotack

Indications for Use: The Endotack is intended for use to provide tibial fixation for surgical correction of cruciate ligament ruptures as well as for cruciate ligament implant replacement.

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

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Concurrence of CDRH, Office of Device Evaluation

(Division Sign-Off)

Division of General. Restorative and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

| Prescription Use: | |
|--------------------------|--|
| (Per 21 CFR 801.109) | |
| OR Over-The-Counter Use: | |

(Optional Format 1-2-96)