MITEK KNOTLESS ANCHOR

{0} Mitek PRODUCTS FEB 13 1998 ETHICON, INC. a Johnson & Johnson company 60 GLACIER DRIVE • WESTWOOD • MA • 02090 PHONE (781) 251-2700 • TOLL-FREE (800) 356-4835 • FAX (781) 461-9166 510(k) SUMMARY FOR K974345 Page 1 of 2 SUBMITTER NAME: Mitek Surgical Products, Inc. ADDRESS: 60 Glacier Drive, Westwood, MA 02090 TEL#: 781-251-2700 CONTACT: Robert Zoletti, Manager, Regulatory Affairs DATE: November 19, 1997 NAME OF DEVICE CLASSIFICATION NAME: Staple, fixation, bone & soft tissue COMMON NAME: Device for holding soft tissue in apposition PROPRIETARY NAME: Mitek Knotless Anchor PREDICATE DEVICE Mitek GII DESCRIPTION OF DEVICE FUNCTION Hold soft tissue in apposition during healing process DEVICE DESIGN The device is 0.430" lg by 0.109" wide with with two 0.026" by 85 degree arcs. MATERIALS USED Titanium body and Nitinol arcs INTENDED USE To lock into bone and hold suture and tissue in apposition during the healing process COMPARISON TO PREDICATE DEVICE Identical intended use with variance in suture handling and knotless function. Made from identical materials. Patient preparation is same with the exception of the tissue apposition process, i.e., the knotless anchor uses a looped version of suture to hold the tissue in place and the GII uses knots to perform the tissue apposition. DESCRIPTION OF NON CLINICAL TESTS Bench top tests showed statistically equivalent strength between the knotless and GII anchors. The pull out failure force from pig femora for : Mitek GII Anchor was 55.63lbs, SD 17.12, and for Knotless Anchor was 60.96lbs, SD 14.29. 003006 {1} DESCRIPTION OF CLINICAL TESTS Clinical tests for the Mitek anchors were done in accordance with IDE G880026. CONCLUSIONS FROM TESTS The Mitek Anchor was found safe and effective by FDA in K892126. 000007 {2} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 13 1998 Mr. Edward F. Kent Vice President Regulatory Affairs Mitek Products 60 Glacier Drive Westwood, Massachusetts 02090 Re: K974345 Trade Name: Mitek Knotless Anchor Regulatory Class: II Product Code: MBI Dated: November 19, 1997 Received: November 19, 1997 Dear Mr. Kent: 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 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 (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 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. {3} Page 2 - Mr. Edward F. Kent 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. 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,  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 {4} Page 1 of 1 510(k) Number (if known): K974345 Device Name: Mitek Knotless Anchor Indications For Use: Shoulder: Bankart repairSLAP Lesion repair acromio-clavicular separation, rotator cuff repair, capsule shift/capsulo-labral reconstruction, biceps tenodesis, deltoid repair. Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, midfoot reconstruction. Foot: Hallux Valgus reconstruction. Elbow: Tennis Elbow repair, biceps tendon reattachment. Knee: Extra capsular repairs, Reattachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament, or joint capsule to tibia and joint capsult closure to anterior proximal tibia, extra capsular reconstruction, ITBtenodesis, patellar ligament and tendon avulsions (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 ☐  (Optional Format 1-2-96) (Division Sign-Off) Division of General Restorative Devices 510(k) Number K974345 000004