CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver

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January 4, 2019 ConMed Corporation Diana Nader-Martone Regulatory Affairs Specialist 525 French Road Utica, New York 13502 Re: K182621 Trade/Device Name: CrossFT™ Knotless Deep Thread Suture Anchor with Disposable Driver Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: November 30, 2018 Received: December 6, 2018 Dear Ms. Nader-Martone: 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). 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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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Laurence D. Coyne -S For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) ### K182621 Device Name CrossFTM Knotless Deep Thread Suture Anchor with Disposable Driver # Indications for Use (Describe) Intended Use The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. Indications for Use The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the suture anchor systems thereby stabilize the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Below the line, the word "CORPORATION" is written in a smaller, lighter font. ### 510(k) SUMMARY In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, CONMED Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) Number K182621 #### I. SUBMITTER CONMED Corporation 11311 Concept Blvd Largo, Florida 33773 Phone: 727-399-5425 Fax: 727-399-5264 Contact Person: Diana L. Nader-Martone Date Prepared: September 21, 2018 #### II. DEVICE NAME | Device Name: | CrossFT™ Knotless Deep Thread Suture Anchor with<br>Disposable Driver | |----------------------|-----------------------------------------------------------------------| | Common Name: | Nonabsorbable Suture Anchor System | | Classification Name: | Fastener, fixation, nondegradable, soft tissue | | Regulatory Class: | Class II, per 21 CFR Part 888. 3040 | | Product Codes: | MBI | #### III. PREDICATE/ LEGALLY MARKET DEVICE | Device Name: | CrossFT™ Knotless Suture Anchor with Disposable Driver | |---------------|--------------------------------------------------------| | Company Name: | ConMed | | 510(k)#: | K163258 | #### IV. REFERENCE/ LEGALLY MARKET DEVICE | Device Name: | ConMed Linvatec Soft Tissue to Bone System | |---------------|--------------------------------------------| | Company Name: | ConMed Linvatec | | 510(k) #: | K091549 | #### V. DEVICE DESCRIPTION The CONMED CrossFT™ Knotless Deep Thread Suture Anchors are manufactured from stable PolyEtherEtherKetone (PEEK). The CrossFT Knotless Deep Thread Anchors are a threaded screw-in suture anchor design. The CrossFT™ Knotless Deep Thread Suture Anchors are provided sterile, preloaded on a single-use driver and some include a preloaded sliding #2 (5 metric) Hi-Fi® Suture. The device is EO sterilized. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for CONMED Corporation. The logo features a stylized blue graphic on the left, resembling a curved shape. To the right of the graphic is the company name, "CONMED," in bold, black letters. Below the company name is the word "CORPORATION" in smaller, black letters. #### INTENDED USE/ INDICATIONS FOR USE VI. The non-absorbable suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. ### COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE The following table represents a summary of the technological characteristics between the proposed and the predicate device. | | CrossFT™ Knotless Deep Thread<br>Suture Anchor with Disposable<br>Driver<br>Proposed Device | CrossFT™ Knotless Suture<br>Anchor with Disposable<br>Driver<br>Predicate Device | ConMed Linvatec Soft Tissue<br>to Bone System<br>(CrossFT™ Suture Anchor<br>with Disposable Driver)<br>Reference | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| | Device Description | The CONMED CrossFT™<br>Knotless Deep Thread Suture<br>Anchors are manufactured from<br>stable PolyEtherEtherKetone<br>(PEEK). The CrossFT Knotless<br>Deep Thread Anchors are a<br>threaded screw-in suture anchor<br>design. The CrossFT™ Knotless<br>Deep Thread Suture Anchors are<br>provided sterile, preloaded on a<br>single-use driver and some<br>include a preloaded sliding #2 (5<br>metric) Hi-Fi® Suture. The<br>device is EO sterilized. | The CONMED CrossFT™<br>Knotless Deep Thread Suture<br>Anchors are manufactured<br>from stable<br>PolyEtherEtherKetone<br>(PEEK). The CrossFT<br>Knotless Deep Thread<br>Anchors are a threaded screw-<br>in suture anchor design. The<br>CrossFT™ Knotless Deep<br>Thread Suture Anchors are<br>provided sterile, preloaded on<br>a single-use driver and some<br>include a preloaded sliding #2<br>(5 metric) Hi-Fi® Suture. The<br>device is EO sterilized. | Reference | | Intended Use | The non-absorbable suture anchors<br>are intended to reattach soft tissue<br>to bone in orthopedic surgical<br>procedures. | Same | Same | | Indication for Use | The device may be used in either<br>arthroscopic or open surgical<br>procedures. After the suture is<br>anchored to the bone, it may be<br>used to reattach soft tissue, such<br>as ligaments, tendons, or joint<br>capsules to the bone. The suture<br>anchor system thereby stabilizes<br>the damaged soft tissue, in<br>conjunction with appropriate<br>postoperative immobilization,<br>throughout the healing period. | Same | Same | | | CrossFT™ Knotless Deep Thread<br>Suture Anchor with Disposable<br>Driver<br>Proposed Device | CrossFT™ Knotless Suture<br>Anchor with Disposable<br>Driver<br>Predicate Device | ConMed Linvatec Soft Tissue<br>to Bone System<br>(CrossFT™ Suture Anchor<br>with Disposable Driver)<br>Reference | | Contraindications | 1. Pathological conditions of bone<br>which would adversely affect<br>the CrossFT™ Knotless Deep<br>Thread Suture Anchor.<br>2. Pathological conditions in the<br>soft tissue to be repaired or<br>reconstructed which would<br>adversely affect suture fixation.<br>3. Physical conditions that would<br>eliminate, or tend to eliminate,<br>adequate implant support or<br>retard healing.<br>4. Conditions which tend to limit<br>the patient's ability or<br>willingness to restrict activities<br>or follow directions during the<br>healing period.<br>5. Attachment of artificial<br>ligaments or other implants.<br>6. Foreign body sensitivity,<br>known or suspected allergies to<br>implant and/or instrument<br>materials.<br>7. This device is not approved for<br>screw attachment or fixation to<br>the posterior elements<br>(pedicles) of the cervical,<br>thoracic or lumbar spine.<br>8. Patients with active sepsis or<br>infection. | Same | Same | | Components | Non-absorbable Anchor<br>Disposable Driver<br>Threader<br>Suture (some catalog numbers) | Non-absorbable Anchor<br>Disposable Driver<br>Threader<br>Suture (some catalog<br>numbers)<br>Suture Tape (some catalog<br>numbers) | Non-absorbable Anchor<br>Disposable Driver<br>Suture | | Technological<br>Characteristics | Non-absorbable,<br>PolyEtherEtherKetone (PEEK)<br>Anchor<br>Screw-in, Knotless Anchor<br>Design<br>Threader<br>Disposable Driver | Same | Non-absorbable,<br>PolyEtherEtherKetone<br>(PEEK) Anchor<br>Screw-in Anchor Design<br>Disposable Driver | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Conmed Corporation. The logo features a blue square with a white, stylized "C" shape inside. To the right of the square is the word "CONMED" in black, sans-serif font, with a horizontal line underneath. Below the line is the word "CORPORATION" in smaller, sans-serif font. ### PERFORMANCE DATA Testing has been completed to demonstrate that the CrossFT™ Knotless Deep Thread Suture Anchor performs as intended and is substantially equivalent to the predicate device. Bacterial endotoxin testing was conducted and met the endotoxin limits. Completed testing includes the following: {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the Conmed Corporation logo. The logo features a blue square with a white curved shape inside on the left. To the right of the square is the word "CONMED" in black, with the word "CORPORATION" in smaller blue letters underneath. K182621 Page 4 of 4 Verification Testing - Reliability ● - Ultimate Fixation Strength ● - Cyclic ● - Sterilization ● - Pyrogen ● - Biocompatibility - Shelf-life - Post Aging Functional Testing ● - MR Safety Testing ● ## VIII. CONCLUSION The CrossFTTM Knotless Deep Thread Suture Anchor with Disposable Driver is either substantially equivalent or identical in design, materials, intended use, principles of operation, and technical characteristics to the predicate ConMed CrossFT™ Knotless Suture Anchor with Disposable Driver. Based upon the findings of our performance testing, the differences present no new issues of safety and efficacy, and the CrossFTM Knotless Deep Thread Suture Anchor with Disposable Driver is substantially equivalent to the ConMed CrossFT™ Knotless Suture Anchor with Disposable Driver (K163258). ## Validation Testing - User Validation ● - Packaging ● - Transportation ●