MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE

{0}------------------------------------------------ K042606 Image /page/0/Picture/1 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A horizontal line is located underneath the word "SYNTHES". ## Summary of Safety and Effectiveness Information [510(k) Summary] 3.0 . MAY 2 7 2005 1000 States of the status and the states of the states of the states of the states of the states of the states of the states of the states of the states of the states of the ( / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / | SPONSOR: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>(610) 647-9700<br>Contact: Lisa M. Boyle | |-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | DEVICE NAME: | Synthes (USA) Titanium Wire | | CLASSIFICATION: | Class II § 21 CFR 878.4495: Stainless Steel Suture | | PREDICATE DEVICE: | Synthes Titanium Wire | | DEVICE DESCRIPTION: | The Synthes Titanium Wire with Barb is a nonabsorbable, monofilament,<br>sterile surgical wire with an attached barb. The 28 gauge titanium wire with<br>barb is available in a length of 538mm and has a permanently attached<br>stainless steel needle. | | INTENDED USE: | Synthes (USA) Titanium Wire is indicated for use in soft tissue<br>approximation and/or ligation, for canthoplasty, canthopexy and/or canthal<br>tendon repair. | | SUBSTANTIAL<br>EQUIVALENCE: | Comparative information presented supports substantial equivalence. | {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three arms or flowing lines, representing health and human services. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 2 7 2005 Ms. Kathy Anderson RA Manager Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania 19380 Re: K042606 Trade/Device Name: Synthes (USA) Titanium Wire Regulation Number: 21 CFR 848.4495 Regulation Name: Stainless steel suture Regulatory Class: II Product Code: GAQ Dated: May 16, 2005 Received: May 17, 2005 Dear Ms. Anderson: 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 for access a not 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 11 70ar action is examined 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 r hat FDA has made a determination that your device complies with other requirements of the Act than I Dr deral statutes 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 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}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) This leaver will anow yourse of substantial equivalence of your device to a legally premarket noticate 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 If you dealer specific as noliance at (240) 276-0115. 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 other general 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, Stupt Rhodes Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use Statement 2.0 Page _ 1 _____________________________________________________________________________________________________________________________________________________________________ KO42606 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number (if known): ______________________________________________________________________________________________________________________________________________________________________________ Device Name: Indications: : Synthes (USA) Titanium Wire is indicated for use in soft tissue approximation and/or ligation, for canthoplasty, canthopexy and/or canthal tendon repair. OR X Prescription Use _ (Per 21 CFR 801.109) 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) Ataturk (Division Sign-Off Division of General, Restorative, and Neurological Devices 510(k) Number K042606 Confidential