MODIFICATION TO: ARTHREX V-TAK

{0}------------------------------------------------ K05-0634 page 14 ## MAR 2 1 2005 # VIII. 510(k) Summary of Safety and Effectiveness ### Arthrex V-Tak™ | Manufacturer / Sponsor | Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, Florida 34108-1945 | |----------------------------------------|------------------------------------------------------------------------------------------------------------------------| | 510(k) Contact: | Ann Waterhouse, RAC<br>Sr. Regulatory Affairs Specialist<br>Telephone: (239) 643-5553 ext. 1179<br>FAX: (239) 598-5508 | | Trade Name: | Arthrex V-Tak™ | | Common Name: | Fastener, Fixation, Degradable, Soft Tissue | | Product Code /<br>Classification Name: | MAI, 21 CFR 888.3030<br>Fastener, Fixation, degradable, Soft Tissue | | Predicate Device: | Arthrex WristTak K022234 | #### Device Description and Intended Use: The Arthrex V-Tak™ is a fully threaded, notched, degradable anchor. The Arthrex V-Tak™ is intended to provide fixation of suture to bone in surgeries of the foot, ankle, hand, wrist, and elbow. #### Substantial Equivalence: The Arthrex V-Tak™ is substantially equivalent to the predicate Arthrex WristTak in which the basic features and intended uses are the same. Any differences between the Arthrex V-Tak™ and the predicate Arthrex WristTak are considered minor and do not raise questions concerning safety and effectiveness. Based on the information submitted, Arthrex, Inc. has determined that the V-Tak™ is substantially equivalent to the currently marketed predicate device. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and well-being. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 2 1 2005 Ms. Ann Waterhouse, RAC Regulatory Affairs Specialist Arthrex. Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945 Re: K050634 Trade/Device Name: Arthrex V-Tak™M Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: March 10, 2005 Received: March 11, 2005 Dear Ms. Waterhouse: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined 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 date of the Medical Device Amendments, or 10 conniner to may 2011-11-11 in accordance with the provisions of the Federal Food, Drug, de rices that mave been require approval of a premarket approval application (PMA). and Cosmeties for ( 10) ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 ou may, diereleve, missis of the Act include requirements for annual registration, listing of general controls pro view with the ling, 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 to such additional controls. Existing major regulations affecting your device can may or subject to back as 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 r that FDA has made a determination that your device complies with other requirements of the Act that 1.71 has made a and regulations administered by other Federal agencies. You must or any I 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 Srith 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. Ann Waterhouse, RAC This letter will allow you to begin marketing your device as described in your Section 510(k) r mo leter watification. 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 (240) 276-0120. 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/industry/support/index.html Sincerely yours, Mark A. Millhouser Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Page 3 -- Ms. Ann Waterhouse, RAC cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ-410 Division D.O. f/t:Psung:tmj:3-18-05 {4}------------------------------------------------ ## III. Indications for Use Form 510(k) Number (if known): ______ Kos-06)4 #### Device Name: Arthrex V-Tak TM Indications for Use: The Arthrex V-Tak™ is intended to provide fixation of suture to bone in surgeries of the foot, ankle, hand, wrist, and elbow. Specific indications are listed below: - Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Elbow. Reconstruction - Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction - Foot: Hallux Valgus reconstruction - Ankle: Mid-foot reconstruction Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of Mullerson erni. Restorntive, and Neurological Devices 5160. Number K050634