2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors

{0}------------------------------------------------ Image /page/0/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked one behind the other. The faces are rendered in a simple, abstract style. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 28, 2015 Tornier, Incorporated Ms. Kaitlyn Rainbow Sr. Regulatory Affairs Specialist 10801 Nesbitt Avenue South Bloomington, Minnesota 55437 Re: K150715 Trade/Device Name: 2.5mm Insite Ft Suture Anchors , 3.5mm Insite Ft Suture Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: June 19, 2015 Received: June 22, 2015 Dear Ms. Rainbow: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the {1}------------------------------------------------ Page 2 - Ms. Kaitlyn Rainbow quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use ### 510(k) Number (if known) K150715 Device Name 2.5mm & 3.5mm Insite™ FT PEEK Suture Anchor Indications for Use (Describe) ntended Use: The 2.5mm and 3.5mm Insite™ FT PEEK Suture Anchor is intended for total shoulder arthroplasty of the shoulder. Indications for Use: The Tornier Insite™ FT PEEK Suture Anchors are intended for fixation of soft tissue to bone. The Tornier Insite™ FT PEEK Suture Anchors are intended for use in the following applications: 1. Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Bicens tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction. 2. Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction. 3. Knee: Medial collateral and Lateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Illiotibial band tenodesis. 4. Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction. 5. Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction. Type of Use (Select one or both, as applicable) | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | |--------------------------------------------------------------------------------------| | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary Date Prepared: July 24, 2015 #### I. Administrative Information | Name: | Tornier, Inc. | |-----------------|---------------------------------------------------------| | Address: | 10801 Nesbitt Avenue South<br>Bloomington, MN 55437 | | Contact Person: | Kaitlyn Rainbow<br>Senior Regulatory Affairs Specialist | | Phone: | 952-426-7637 | | Fax: | 952-426-7601 | #### II. Device Information Name of Device: Insite™ FT PEEK Suture Anchor Size 2.5mm & 3.5mm Common Name: Fastener, Fixation, Non-degradable, Soft Tissue Classification Name: 21 CFR 888.3040, Smooth or treaded metallic bone fixation fastener Class II Regulatory Class: Product Code: MBI #### III. Predicate Device Information Tornier Insite™ FT PEEK Knotless Suture Anchor K110773 and Smith and Nephew 2.0PK Suture Anchor K081511. #### IV. Device Description The Insite™ FT PEEK Suture Anchor is a bone implant device intended for the fixation of soft tissue to bone. This device is a fully threaded PEEK-OPTIMA® anchor that is available in two sizes (2.5mm & 3.5mm) for use in a range of fixation applications. #### V. Intended Use The Tornier Insite™ FT PEEK Suture Anchor is intended for the fixation of soft tissue to bone. #### VI. Indications for Use The Tornier Insite FT PEEK Suture Anchors are intended for fixation of soft tissue to bone. The Tornier Insite FT PEEK Knotless Suture Anchors are intended for use in the following applications: {4}------------------------------------------------ - 1. Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction. - 2. Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction. - 3. Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Illiotibial band tenodesis. - 4. Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction. - 5. Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction. This device is for single use. #### VII. Comparison of Technological Characteristics with the Predicate Device The Insite™ FT Suture Anchor has the same intended use and fundamental scientific technology as the predicate device. The design differences have been demonstrated to not affect safety or effectiveness or raise new issues of safety or effectiveness. #### VIII. Performance Data Non-clinical performance bench testing (mechanical testing) was performed to demonstrate substantial equivalence to the predicate devices. Non-clinical Performance Testing Summary for 2.5mm & 3.5mm Insite™ FT PEEK Suture Anchors {5}------------------------------------------------ | Validation and/ or Verification<br>Method | Acceptance Value/Criteria | Verification and<br>Validation Results | |--------------------------------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------| | Mechanical Testing<br>(Suture Approximation and<br>Tensile Pull-out) | To exceed strength of predicate<br>device | Acceptable | | Mechanical Testing<br>(Cyclic Load Test) | To meet the physiological loading<br>requirements | Acceptable | | Mechanical Testing<br>(Anchor Insertion Torque and<br>Driver Torque to Failure Test) | To exceed the strength of the<br>expected loading requirements | Acceptable | | Mechanical Testing<br>(Pull to Failure Testing) | To determine strength of predicate<br>device | Acceptable | | Cadaver Lab Evaluation | Successful preparation in<br>cadaveric specimens | Acceptable | #### IX. Clinical Study Clinical studies were not required to demonstrate substantial equivalence between the subject device and the predicate device. #### X. Conclusions The Insite™ FT Suture Anchor size 2.5mm and 3.5mm described in this section has the same intended use and the same fundamental scientific technology as the cleared Insite™ FT Suture Anchor and Smith and Nephew 2.0PK Suture Anchor. Based on the testing presented for the design differences between the subject and predicate devices, Tornier concludes that subject device is substantially equivalent to the predicate device.