SYNTHES BUTTON PLATE

{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 small circled "R" trademark symbol is located to the right of the word. : MAR 1 5 2000 . Image /page/0/Picture/2 description: The image contains a sequence of alphanumeric characters that appear to be handwritten. The characters are 'K994364', with the 'K' being a capital letter followed by a series of numbers. The handwriting is somewhat stylized, with some characters connected and others distinct. : | Attachment VI | Summary of Safety and Effectiveness Information<br>[510(k) Summary] | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | SUBMITTER | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>(610) 647-9700<br><br>Contact: Sheri L. Musgnung | | DEVICE NAME: | Synthes Button Plate | | COMMON OR USUAL<br>NAME | Fastener, Fixation, nondegradable, Soft Tissue | | DEVICE<br>CLASSIFICATION: | Class II, 21 CFR 808.3030 | | PREDICATE DEVICE: | Arthrex's Bio-Button | | DESCRIPTION: | Synthes Button Plate is a pre-bent plate consisting of seven holes<br>for passing up to #5 sutures. The plate is 0.7 mm thick, 10 mm<br>in width, and is 17 mm in length. The Button Plate is<br>manufactured from titanium and is MRI safe. | | INTENDED USE: | Synthes Button Plate is intended for augmentation of<br>transosseous rotator cuff repair, especially in massive tears and<br>reruptures in proximity to osteopenic bone | CONFIDENTIAL 000049 : {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## Mar 1 5 2000 Ms. Sheri L. Musgnung Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301 Re: K994364 Trade Name: Synthes Button Plate Regulatory Class: Class II Product Codes: MBI, KGS Dated: December 23, 1999 Received: December 27, 1999 Dear Ms. Musgnung: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 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. {2}------------------------------------------------ Page 2 - Ms. Sheri L. Musgnung If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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, Niel R. Ogle Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ | 1 | | | | |---|---------------------------------------|---------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | A Children Controller<br>------------ | <br>AAA | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>A .- CHEVROL COLL LEVELLE .- CHE .- CHE .- CHERE A LA | | | | | | | 510(k) Number (if known): | K994364 | |---------------------------|---------| |---------------------------|---------| Device Name: Synthes Button Plate Indications For Use: Synthes Button Plate is intended for augmentation of transosseous rotator cuff repair, especially in massive tears and reruptures in proximity to osteopenic bone. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) × Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ NRO fvc cmw (Division Sign-Off) Division of General Restorative Devices | 510(k) Number | K994364 | |---------------|---------| |---------------|---------| CONFIDENTIAL