FEMORAL HOOK

{0}------------------------------------------------ JUN - 7 2004 BIOMET ## 510(k) Summary | Applicant/Sponsor: | Arthrotek. Inc.<br>(A wholly owned subsidiary of Biomet, Inc.)<br>56 East Bell Drive<br>P.O. Box 587<br>Warsaw, Indiana 46581-0587 | |-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Gary Baker<br>Biomet Manufacturing Corp.<br>P.O. Box 587<br>Warsaw, Indiana 46581-0587<br>Telephone: (574) 372-1568<br>Fax: (574) 372-1683 | | Proprietary Name: | Femoral Hook | | Common Name: | Soft Tissue Anchor | | Classification Name: | Fastener, fixation, non-degradable, soft tissue | | Legally Marketed Devices To Which Substantial Equivalence Is Claimed: | Titanium Toggle Button (K033838) - Arthrotek Inc. | | Device Description: | The Femoral Hook device includes a body and an arm. The body<br>incorporates an eyelet that provides a means to attach the soft tissue<br>grafts. The arm is used to anchor the body to the cortical bone. | | Intended Use: | The Femoral Hook is intended for soft tissue fixation to bone. | | | The Indications for Use are:<br>Fixation of tendons and ligaments during orthopedic<br>reconstruction procedures such as Anterior Cruciate<br>Ligament (ACL) Reconstruction. | | Summary of Technologies: | The Femoral Hook has the same intended use, and functional<br>characteristics as the predicate device, and uses the same<br>titanium alloy as the predicate device body. | | Non-Clinical Testing: | Mechanical testing indicated that the Femoral Hook<br>had a greater pull-out strength than the predicate device. | | Clinical Testing: | No clinical testing was provided as a basis for substantial<br>equivalence. | 73 MAHING ADDRESS P.O. Box 587 Wirshw, IN 16581-0587 SHIPPING SHIPPING ADDRISS CONSECT - SO E. Bell Diversity - S6 E. Bell Diversity - Warsaw, IN - 46582 ())[/((()[)()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()(()()()(()(()()(()(()(()()((()()(()(()(()(()()((()()((()()()((()()((() 5 ? 1.26 ? (66,39) = E-MAII. E = = {1}------------------------------------------------ : : ______________________________________________________________________________________________________________________________________________________________________________ {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 **JUN - 7 2004** Gary Baker Regulatory Specialist Biomet Manufacturing Corporation 56 E. Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587 Re: K041261 Trade/Device Name: Femoral Hook Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: MBI Dated: May 10, 2004 Received: May 11, 2004 Dear Mr. Baker: We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device American Fig. connieres prior to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, de vices that have ocen require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mererore, mains 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 If your device is elassified (sisted controls. Existing major regulations affecting your device can may be subject to sach additions, 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 r lease oe actived that I be mination that your device complies with other requirements of the Act that I DA has made a sond regulations administered by other Federal agencies. You must of any I ederal statutes and regulaments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IT Fart 8077, adoling (21 CFR Part 820); and if applicable, the electronic forth in the quand by by the est (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ ## Page 2 - Gary Baker This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin mailering of substantial equivalence of your device to a legally premarket notification: "The PDF milling of basification 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 If you desire specific advice for your ac 1100 %. 4659. Also, please note the regulation entitied, Colliation of Compullars as (bet notification" (21CFR Part 807.97). You may obtain "Misoranumig by ICrerchec to premailters under the Act from the Division of Small other general information on your responsibilities under the Act from the 1900 628, 000 other general information on your responser 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 Sincerely yours, 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 {4}------------------------------------------------ ## Indications For Use . - - ----- 510(k) Number (IF KNOWN): Device Name: Femoral Hook Indications for Use: Fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction. Prescription Usc AND/OR (Per 21 CFR 801 Subpart D) 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 N. Milhusan ivision Division of General, Restorative, and Neurological Devices Page 1 of 1 510(k) Number K041261 7