STRYKER WEDGE SUTURE ANCHOR

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for Stryker Endoscopy. The word "stryker" is written in a bold, sans-serif font, with the "s" and "t" connected. A registered trademark symbol is located to the right of the word "stryker". Below "stryker" is the word "ENDOSCOPY" in a smaller, sans-serif font. # 2590 Walsh Avenue Santa Clara, CA 95054 Phone: (408) 567-9100 x2228 Fax: (408) 567-2507 Todd Miller October 8, 1998 # SUMMARY OF SAFETY AND EFFECTIVENESS #### Device Name: | Classification Name: | Smooth or Threaded Metallic Bone Fixation Fasteners:<br>CFR 888.3040, Class II | |----------------------------|--------------------------------------------------------------------------------| | Device Product Code: | Panel Code 87, Orthopedic Devices, MBI | | Common and Usual Name: | Fastener, Fixation, Non-degradable, Soft Tissue<br>(87MBI) | | Proprietary Name: | Stryker Wedge Suture Anchor System | | Regulatory Classification: | Class II | #### Safety and Effectiveness Summary: This summary of 510(k) safety and effectiveness is being submitted in accordance with requirements of SMDA 1990. Stryker Wedge Suture Anchors are titanium alloy implants used to anchor suture within bone sites for firmly securing soft tissue to bone. The Anchors are self-drilling, self-tapping, threaded devices. The Anchor is supplied with non-absorbable braided polyester suture assembled to a disposable inserter. The sutures are color-coded white and green for visual identification of the individual strands during use. The Stryker Wedge Suture Anchor System is intended for use in securing soft tissue to bone in such procedures as rotator cuff tear repair, bankart lesion repair, and SLAP lesion repair in the shoulder, as well as achilles tendon repair in the foot/ankle, medial collateral ligament repair in the knee, scapholunate ligament reconstruction in the hand/wrist, and biceps tendon reattachment in the elbow. The Stryker Wedge Suture Anchor system is intended for the fixation of surgical suture material to the pelvis only for the purpose of bladder neck suspension female urinary incontinence due to urethral hyper mobility or intrinsic sphincter deficiency. The Stryker Wedge Suture Anchor System is equivalent in intended use, safety and effectiveness to other fixation devices in commercial distribution. The Stryker Wedge Suture Anchor System will be provided sterile for single-use applications (ASTM 4169). This device will be sterilized by Gamma irradiation and validated (AAMI ST32) to a sterility assurance level (SAL) of 10-6. The material of construction and its overall design are equivalent to currently marketed products. The device materials are biocompatible per ASTM F136 and ISO-10993. {1}------------------------------------------------ The anchor system does not raise any new safety and efficacy concerns when compared to other devices currently on the market. Therefore, the Stryker Wedge Suture Anchor System is substantially equivalent to other suture anchor devices. The Stryker Wedge Suture Anchor System is substantially equivalent to the Arthrex FASTak™ Suture Anchor, marketed under 510(k) K960516, in the following fields: - � Intended use - Material . .. - Geometry ◆ - . Thread design - . Head design - Eyelet design � - . Operational principles - Indications & Contraindications ● See Table 1 and Table 2 for comparison of anchor systems. ### TABLE 1 Comparison of Stryker Wedge Suture Anchor System to Arthrex FASTak Suture Anchor | COMPANY | Stryker | Arthrex | |------------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------| | TRADE NAME | Stryker Wedge Suture Anchor<br>System | Arthrex FASTak™ Suture<br>Anchor | | INTENDED USE | Soft tissue fixation to bone | Soft tissue fixation to bone | | MATERIAL | Titanium<br>(Ti 6Al 4V) | Titanium<br>(Ti 6Al 4V) | | DESIGN: | | | | 1. Body geometry | Wedge shaped or tapered | Cylindrical then tapered | | 2. Thread design | Spiral | Spiral | | 3. Driving head<br>design | Standard hexagonal | Standard hexagonal | | 4. Suture eyelet<br>design | Large, round, smooth | Large, round, smooth | | 5. Diameters (mm) | 1.9<br>2.7<br>3.4<br>4.5<br>4.9 | 2.4 | | 6. Lengths (mm) | 8<br>11<br>14<br>16<br>13.6 | 11.7 | | OPERATIONAL<br>PRINCIPLES | Provide stable fixation of soft<br>tissue to bone; simple anchor<br>insertion technique | Provide stable fixation of soft<br>tissue to bone; simple anchor<br>insertion technique | | INDICATIONS &<br>CONTRAINDICATIONS | See Users Insert (Tab B) | same | | STERILIZATION | Gamma Radiation | EtO, Gamma Radiation | {2}------------------------------------------------ | Company/Device | Size (mm) | Insertion | Failure Strength (lbf) | |--------------------------------|-----------|-----------|-------------------------------------------------------------| | Stryker Wedge<br>Suture Anchor | 1.9 | Screw in | Diaphyseal: 43.5 *<br>Metaphyseal: 51.8<br>Cancellous: 40.7 | | Stryker Wedge<br>Suture Anchor | 2.7 | Screw in | Diaphyseal: 53.9 *<br>Metaphyseal: 47.6<br>Cancellous: 49.9 | | Stryker Wedge<br>Suture Anchor | 3.4 | Screw in | Diaphyseal: 73.7 *<br>Metaphyseal: 72.9<br>Cancellous: 74.7 | | Stryker Wedge<br>Suture Anchor | 4.5 | Screw in | Diaphyseal: 73.6 *<br>Metaphyseal: 72.8<br>Cancellous: 75.4 | | Stryker Wedge<br>Suture Anchor | 4.9 | Screw in | 18 pcf foam: 47.6** | | Arthrex FASTak<br>K960516 | 2.4 | Screw in | Diaphyseal: 38 ***<br>Metaphyseal: 43<br>Cancellous: 43 | # TABLE 2 Comparison of Anchor Pull-out Strength in Bone Study performed by Barber and Lorang, Plano Orthopedic & Sports Medicine J t Center Testing performed using 18 pcf density foam block to simulate cancellous bone ** *** Barber, M.D., "Suture Anchor Strength Revisited" Arthroscopy: The Journal of Arthroscopic and Related Surgery, February, 1996. Todd Miller Design Engineer {3}------------------------------------------------ Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, and is often used as a symbol of medicine. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the caduceus symbol. DEC 1 8 1998 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Todd Miller Design Engineer Stryker Endoscopy 2590 Walsh Avenue 95054 Santa Clara, California Re: K983557 Styker Wedge Suture Anchor System Requlatory Class: II Product Codes: MBI and GAT Dated: October 8, 1998 Received: October 13, 1998 Dear Mr. Miller: 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. ದ 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 requlation 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. {4}------------------------------------------------ Page 2 - Mr. Todd Miller This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acberious in four alone of your device to a legally marketed predicate device results in a classification for your markets predicate and the your device to proceed to the market. If you desire specific advice for your device on our labeling requlation (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 che promocron and (301) 594-4639. Also, please note the Orice Of Compiland. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general premation on your responsibilities under the Act may be rhroimation 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, 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 {5}------------------------------------------------ Page 1 510(k) Number (if known): _ 9 8 3 5 5 7 Device Name: Stryker Wedge Suture Anchor System Indications For Use: The intended use of the Stryker Wedge Suture Anchor System is for securing soft tissue to bone in such procedures as rotator cuff tear repair, bankart lesion repair, and SLAP lesion repair in the shoulder, as well as achilles tendon repair in the foot/ankle, medial collateral ligament repair in the knee, scapholunate ligament reconstruction in the hand/wrist, and biceps tendon reattachment in the elbow. The Stryker Wedge Suture Anchor system is intended for the fixation of surgical suture material to the pelvis only for the purpose of bladder neck suspension female urinary incontinence due to urethral hyper mobility or intrinsic sphincter deficiency. The suture anchor engages in bone so as to provide a stable bony attachment site for the soft tissue. This device is intended to be used primarily in arthroscopic repairs, but is suitable in open procedure as well, and is intended for single-use only. This device is infended for use only for the fixation of non-absorbable synthetic sutures. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General Restorative Devices 510(k) Number. K983557 | Prescription Use_ | X | |----------------------|---| | (Per 21 CFR 801.109) | | OR Over-The-Counter Use