EZLOC FEMORAL FIXATION DEVICE

{0}------------------------------------------------ K053461 page 171 ## 510(k) Summarv FER 3 2006 Applicant/Sponsor: Arthrotek, Inc. Contact Person: Susan Alexander Proprietary Name: EZLoc™ Femoral Fixation Device Common Name: Soft tissue anchor Classification Name: Fastener, Fixation, Non-degradable, Soft Tissue (888.3040) ## Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Titanium Toggle Button (K033838) and Femoral Hook (K041261) Device Description: The EZLoc™ Femoral Fixation Device is the same design as the predicate Femoral Hook (EZLoc™), deared in K041261, with additional sizes. The device includes a body, an arm, a passing pin and a pull suture. The implant will be available in three diameters: 5-6mm, 7-8mm and 9-10mm; and five lengths: 15mm, 20mm, 25mm, 30mm and 35mm. The sizes will account for the varying diameters and lengths of the replacement graft and femoral tunnel length. Currently the devices are packaged with a #2 polyethylene suture, but may also be used with any legally marketed, nonresorbable suture. Intended Use: Fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction. Summary of Technologies: The technological characteristics (material, design, sizing, indications) of the EZLoc™ Femoral Fixation Device are similar to or identical to the predicate devices. The EZLoc™ Femoral Fixation Device has been modified to include new sizes. Non-Clinical Testing: Non-cilnical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use. Clinical Testing: None provided as a basis for substantial equivalence. All trademarks are property of Arthrotek, Inc., a wholly-owned subsidiary of Biomet, Inc. MARK MALING ANDRESS ラニ + _ _( \ _ _( \ _( \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Public Health Service FEB 3 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Susan Alexander Regulatory Specialist Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 46581-0587 Re: K053461 Trade/Device Name: EZLoc™ Femoral Fixation Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MBI Dated: December 12, 2005 Received: December 13, 2005 Dear Ms. Alexander: 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. {2}------------------------------------------------ Page 2 - Ms. Susan Alexander 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 (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincercly yours, 2 / Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known): EZLoc™ Femoral Fixation Device Device Name: Indications For Use: Fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction. Prescription Use (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) | (Division Sign-Off) | Page 1 of 1 | |-----------------------------------------------------------|-------------| | Division of General, Restorative,<br>Neurological Devices | | | Number | K053461 | | | 8 |