SOFT TISSUE SUTURE WASHER

{0}------------------------------------------------ 11/29/99 K991135 # Exhibit I # 510(k) Summary Soft Tissue Suture Washer DePuy, Inc. 700 Orthopaedic Drive Warsaw, IN 46581 #### A. Contact Person: Janet G. Johnson, RAC Senior Regulatory Associate (219) 372-7484 ### B. Device Information: | Proprietary Name: | Soft Tissue Suture Washer | |----------------------|---------------------------------------------------------------------------------| | Common Name: | Suture Washer | | Classification Name: | Single/multiple component metallic bone fixation<br>appliances and accessories. | | Regulatory Class: | Class II, per 21 §CFR 888.3030 | | Product Code: | 87 HTN | #### C. Indications for Use: To provide fixation to bone of the tibial and/or femoral end of a bone-patellar tendon-bone graft or other soft tissue graft material used to reconstruct the ACL and/or PCL in an intraarticular procedure of the knee. #### D. Device Description: The Soft Tissue Suture Washer is a titanium alloy (Ti-6A1-4V) three-hole suture washer that is intended to be used with cancellous or cortical bone screws. This suture washer is designed to prevent migration of screw head into the bone and provide an anchoring site for sutures. #### E. Substantial Equivalence: The Soft Tissue Suture Washer is substantially equivalent in terms of intended use, materials, design, manufacturing and packaging to the current DePuy OrthoTech Soft Tissues Suture Washer (K910229). The determination of substantial equivalence for this device was based on a detailed device description, and conformance with voluntary performance standard ASTM F136. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of a bird or eagle with three curved lines representing its wings or feathers. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 2 9 1999 Janet G. Johnson, RAC Senior Regulatory Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive 46581-0988 Warsaw, Indiana Re: K991135 Soft Tissue Suture Washer Trade Name: Requlatory Class: II Product Code: HTN Dated: April 1, 1999 Received: April 5, 1999 Dear Ms. Johnson: 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 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 controls provisions The general controls provisions of the Act 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 requirement, 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 In addition, FDA may publish further announcements action. 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. {2}------------------------------------------------ Page 2 - Janet G. Johnson, RAC 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 marketed produced of mits your device to proceed to the market. 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) 594-4659. 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" (21 CFR 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/dsmamain.html". Sincerely yours, Witten, Ph.D., M.D. a M. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ #### K991135 510(k) Number (if known) Soft Tissue Suture Washer Device Name # Indications for Use To provide fixation to bone of the tibial and/or femoral end of a bone-patellar tendon-bone graft or other soft tissue graft material used to reconstruct the ACL and/or PCL in an intraarticular procedure of the knee. (Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE) Dudley gn-Off) (Division S Division of General Restorative Devices 11-991135 510(k) Number Prescription Use_X (Per 21 CFR §801.109) OR Over-the-Counter Use (Optional Format 1-2-96)