SYNTHES 1.0/1.2 MM PLUSDRIVE SCREWS

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a stylized image inside. A horizontal line runs beneath the word, emphasizing the brand name. The logo and text are clear and easily readable. . : K042356 ## OCT 7 - 2004 | 3.0 | 510(k) Summary | Page 1 of 1 | |-----|----------------|-------------| |-----|----------------|-------------| | Sponsor: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>(610) 647-9700 | |-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | Synthes 1.0/1.2 mm Plusdrive Screws | | Classification: | 21 CFR 888.3040: Smooth or Threaded Metallic Bone Fixation<br>Fastener | | Predicate Device: | KLS Martin 1.0mm Center-Drive Screw System<br>Synthes Maxillofacial Titanium Micro Set | | Device Description: | The 1.0/1.2 mm Plusdrive Screws are either self-drilling or self-<br>tapping, have a flat head profile with rounded edges with a<br>cruciform recess, and are available in various lengths. | | Intended Use: | The Synthes 1.0/1.2 mm Plusdrive screws are intended for fracture<br>fixation in hand surgery and neurosurgery. | | Substantial<br>Equivalence: | Documentation is provided which demonstrates that the Synthes<br>1.0/1.2mm Plusdrive Screws are substantially equivalent to other<br>legally marketed devices. | | | The term "substantial equivalence" as used in this 510(k)<br>notification is limited to the definition of substantial equivalence<br>found in the Federal Food, Drug and Cosmetic Act, as amended<br>and as applied under 21CFR 807, Subpart E under which a device<br>can be marketed without premarket approval or reclassification. A<br>determination of substantial equivalency under this notification is<br>not intended to have any bearing whatsoever on the resolution of<br>patent infringement suits or any other patent matters. No<br>statements related to, or in support of substantial equivalence<br>herein shall be construed as an admission against interest under the<br>US Patent Laws or their application by the courts. | {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird, with its wings spread and head facing left. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 7 - 2004 Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road Paoli. Pennsylvania 19301 Re: K042356 Trade/Device Name: Synthes (USA) 1.0/1.2 mm Plusdrive Screws Regulation Number: 21CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: August 27, 2004 Received: August 31, 2004 Dear Ms Boyle: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave 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 sured in the encreativent of 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 I ou may, dierely missus 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 your de room 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 sct 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. Lisa M. Boyle This letter will allow you to begin marketing your device as described in your Section 510(k) rremarket 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 (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 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 Sincerely yours, Sincerely yours, Mark Millman 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 Synthes logo. The logo consists of a circular symbol on the left and the word "SYNTHES" in bold, black letters on the right. There is a registered trademark symbol to the right of the word "SYNTHES". There is a horizontal line below the logo. 1 Page 1 of 2.0 Indications for Use 510(k) Number (if known): K042356 Device Name: Synthes (USA) 1.0/1.2 mm Plusdrive Screws Indications for Use: The Synthes 1.0/1.2 mm Plusdrive Screws are intended for fracture fixation in hand surgery and neurosurgery. X Prescription Use (Per 21 CFR 801.109) 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) | | <img alt="Signature" src="signature.png"/> | |---------------|--------------------------------------------| | | (Division Sign-Off) | | | Division of General, Restorative, | | | and Neurological Devices | | 510(k) Number | K042356 |