ACL CLIP-IN

{0}------------------------------------------------ K973323 ## 510 (K) SUMMARY # DEC - 1 1997 - Date of Summary Preparation 1 Sept. 2, 1997 ### Submitter's Name & Address 2 Innovasive Devices, Inc. 734 Forest Street, Marlborough, MA 01752 Telephone: 508-460-8229 508-460-8997 Fax: - 3 Contact Person MR. Eric Bannon Vice President, QA/RA #### 4 Manufacturer's Contact Person Mr. T. Wade Fallin Exec. Vice President Innovasive Devices, Inc. 180 South 600 West Logan, UT 84321 Telephone: 801-753-7675 Fax: 801-753-7698 - 5 Proprietary Device Name ACL Clip-In - 6 Common Name Endosteal Fixation Device #### 7 Classification Name Smooth or Threaded Metallic Bone Fixation Fastener. Single/multiple component bone fixation appliances and accessories - 8 Classification Reference 21CFR 888.3030 - 9 Device Product Code 87 MBI - 10 Regulatory Class Class II {1}------------------------------------------------ #### 11 Materials The following material is used in the manufacturing of the Base and Eyelets. Ti-6A1-4V ELI per ASTM F-136. Nitinol Wire (Ni-Ti Alloy) #### Indications for Use 12 Innovasive Devices, Inc., ACL Clip-In is indicated for use in the fixation of ligament and tendon grafts in cruciate ligament reconstruction surgeries. #### Description 13 ### Intended Use The Innovasive Devices, Inc., ACL Clip-In is intended to be a fixation device in the repair of tendons and ligaments in Cruciate Reconstructive surgery. ### Technological Characteristics The ACL Clip-In device is a two component implant used in the fixation of ligament and tendon grafts in cruciate ligament reconstruction surgeries. The two device components are the Base and the Eyelet which are assembled together in the bone during the surgical procedure. The ACL Clip-In device consists of an outer threaded Base which is designed to be endoscopically delivered through a prepared tibio-femoral tunnel and manually inserted into the antero-lateral femur using a hex driver. The proximal end of the Base has a flexible wire assembled to it. The Eyelet has a smooth transverse opening to accept the soft tissue without damaging it. The proximal end of the Eyelet has a circular groove which is of a larger diameter of the flexible wire in the Base. The flexible wire provides for a spring like property as the Eyelet passes through the Base. When the proximal end of the Eyelet engages with the flexible wire, it locks the Eyelet in place. With regard to implant size, the Base comes in 8mm, 10mm and 12mm diameters. The Eyelets are size specific and can be used only with the specified base component. The components will be labeled to indicate the same. #### Substantially Equivalent Predicate Devices 14 | FRA B<br>BLE | | | | | | | |-----------------------------|---------------------|-----------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|--|--| | .<br>1 8 ---<br>100 100 100 | -40 D --------<br>S | יינו<br>C | .<br>1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 -<br>THE CA | 00 | | | | | | | | | | | | MANUFACTURER'S<br>NAME | DEVICE NAME | 510(k) DOCUMENT NO. | 510(k)<br>CLEARED | |----------------------------------------|--------------------------|---------------------|-------------------| | Innovasive Devices,<br>Marlborough, MA | 8mm Ligament<br>fastener | K970316 | Yes | {2}------------------------------------------------ #### Substantial Equivalence 15 ### 15.1 Technological Characteristics ### 15.1.1 Similarities - (a) The ACL Clip-In device shares very similar technological characteristics with the predicate device. Both devices have: - 1) a bone fixation element, and - 2) a linkage element that connects the graft to the bone fixation element. - (b) The bone fixation element is an externally threaded, internally cannulated Base. - (c) The linkage element is an Eyelet with a transverse opening for receiving the graft and a proximal pin which locks into the Base. ### 15.1.2 Technological Differences The ACL Clip-in uses different materials that the predicate device. #### 15.2 Rationale for Differences - (a) The subject device uses a well proven material which provides for greater strength and biocompatability. - (b) Another potential clinical advantage is afforded by the connection means between the bone fixation element and the linkage element. This connection provides an axial lock, but will allow for rotational movement. Thus, the surgeon can adjust graft position along the axis of the bone tunnel after the linkage element, with graft attached, is connected to the bone fixation element. This is accomplished by engaging the Clip-In removal tool on the distal end of the Eyelet and turning it to reposition the graft in a distal to inferior direction. - (c) A further potential clinical advantage is the ability to disengage the linkage element from the bone fixation element without damaging the linkage element or the graft by use of a simple removal punch. This may be an advantage in the event that the surgeon may need to reconfigure the linkage-graft construction. This removal tool engages the proximal end of the assembled bone fixation element and linkage element, and provides release with a rotationally directed compression force. Also provided is a implant removal tool, which helps unthread the assembly (base + eyelet) via the tibio-femoral tunnel. #### 16 Performance Data No performance standards exist at this time for the regulatory class under which the ACL Clip-in is proposed for classification. However, in support of this submission, Innovasive {3}------------------------------------------------ Devices, Inc. has conducted the voluntary device testing in order to assess the effects of the new technological characteristics on the modes of failure of the device. The effects of different materials on the modes of failure of the subject device were assessed in comparative testing with a selected predicate device. The testing performed was: - Strength of implant-implant interface . - Strength of implant-graft-host bone construct . - a. Static - b. Dynamic Post-test evaluation included: - Host Bone- Implant Interface ● - Graft Implant Interface ● - Graft Incorporation With regard to testing, the subject device demonstrated at a minimum equivalent or better performance compared to the selected predicate device in each of the three tests outlined above. With regard to post test evalutaion, the subject device demonstrate equivalent or better performance compared to the selected predicate device in post dynamic test evaluations of the host bone-implant interface and the graft-implant interface. Provisions for graft incorporation are essentially identical between the subject and predicate devices, as all provide transverse support of the soft tissue loop and all provide the same amount of graft-host bone surface area contact to facilitate graft incorporation. #### 17 Conclusion Based on the design concept, use of standard material, feature comparisons to a selected predicate device, the device and predicate device testing, Innovasive Devices, Inc. believes that sufficient evidence exists to conclude that the ACL Clip-In Device is substantially equivalent to existing legally marketed endosteal fixation devices. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird. The text is in all capital letters and is evenly spaced around the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC - 1 1997 Mr. Eric Bannon ·Vice President, Quality Assurance/Regulatory Affairs Innovasive Devices, Inc. 734 Forest Street 01752 Marlborough, Massachusetts K973323 Re: ACL Clip-In Trade Name: Regulatory Class: II Product Code: MBI and HWC Dated: September 2, 1997 Received: September 4, 1997 Dear Mr. Bannon: 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 General regulation (21 CFR Part 820) and that, Devices: 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. {5}------------------------------------------------ ### Page 2 - Mr. Eric Bannon 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. Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ #### INDICATIONS FOR USE 3. #### 3.1 Statement of Indications for Use Innovasive Devices, Inc. (IDI) - ACL Clip-In is indicated for use in the fixation of ligament and tendon grafts in cruciate ligament reconstruction surgeries. **Prescription Use** **(Per 21 CFR 801.109)** Acolla Divis 510k) I