CuffLink Implant System

{0}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with three lines above them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 CONMED Corporation Ms. Dionne Sanders Manager, Regulatory Affairs, Orthopedic Division 525 French Road Utica, New York 13502 September 8, 2017 Re: K171725 Trade/Device Name: CuffLink Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: June 9, 2017 Received: June 12, 2017 Dear Ms. Sanders: 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 {1}------------------------------------------------ Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the 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 (DICE) 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 (DICE) 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. # Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K171725 Device Name CuffLink Implant System ### Indications for Use (Describe) The CuffLink Implant System is intended to reattach soft tissue to bone in orthopedic surgical procedures. The Implant System 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 system thereby stabilizes the damaged soft tissue, in conjunction with appropriative immobilization, throughout the healing period. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 201 Subpart D) | Over-The-Counter Use (21 CFR 201 Subpart C) | |----------------------------------------------|---------------------------------------------| |----------------------------------------------|---------------------------------------------| > 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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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}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for CONMED Corporation. The logo features a blue abstract shape on the left, followed by the word "CONMED" in black, sans-serif font. Below "CONMED" is a thin blue line, and below that is the word "CORPORATION" in smaller, sans-serif font. ## 510(k) SUMMARY #### SUBMITTER I. CONMED Corporation 525 French Road Utica, NY 13502 Phone: 727-399-5564 Fax: 727-399-5264 Contact Person: Dionne Sanders, RAC Date Prepared: June 9, 2017 #### II. DEVICE | Name of Device: | CuffLink Implant System | |-------------------------|----------------------------------------------------| | Trade Name/Common Name: | Non-absorbable Suture Anchors | | Classification Name: | Smooth or threaded metallic bone fixation fastener | | Regulatory Class: | Class II, per 21 CFR Part 888.3040 | | Product Code: | MBI | #### III. PREDICATE DEVICE | Device Name: | CrossFT Knotless Suture Anchor w/Disposable Driver | |---------------|----------------------------------------------------| | Manufacturer: | CONMED Corporation | | 510(k) #: | K163258 | #### IV. DEVICE DESCRIPTION The CuffLink™ Implant System consists of six kits that will be provided sterile, for singleuse only. Each kit will contain four suture anchors, one disposable broaching punch, and one suture passing loop assembled in a single PETG tray, and sealed in a Tyvek pouch. The tray is subsequently placed in a folding carton. ## INTENDED USE / INDICATIONS FOR USE The CuffLink Implant System is intended to reattach soft tissue to bone in orthopedic surgical procedures. The Implant System 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 {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for CONMED Corporation. The logo features a blue abstract shape on the left, followed by the word "CONMED" in a bold, sans-serif font. Below the word "CONMED" is the word "CORPORATION" in a smaller, sans-serif font, underlined by a thin blue line. The logo is clean and professional, suggesting a company in the medical or technology field. tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. ### COMPARISION OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE V. PREDICATE DEVICE CONMED's CuffLink Implant System is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the CONMED CrossFT Knotless and Y-Knot RC Suture Anchors and raises no new issues of safety or effectiveness. The similarities and differences between the predicate and proposed sterilization trays are the following- | | Proposed Device | Predicate Device | Reference Device | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | CuffLink Implant System | CrossFT Knotless Suture<br>Anchor | Y-Knot RC Suture Anchor | | 510k Number | TBD | K163258 | K133224 | | Manufacturer | CONMED Corporation | | | | Intended Use | Intended to reattach soft tissue to bone in orthopedic surgical procedures. | | | | Indications for Use | The device may be used in<br>either arthroscopic or open<br>surgical procedures. After<br>the suture is anchored to<br>the bone, it may be used to<br>reattach soft tissue, such as<br>ligaments, tendons, or joint<br>capsules to the bone. The<br>suture anchor system<br>thereby stabilizes the<br>damaged soft tissue, in<br>conjunction with the<br>appropriate postoperative<br>immobilization,<br>throughout the healing | The device may be used in<br>either arthroscopic or open<br>procedures. After the<br>suture is anchored to the<br>bone, it may be used to<br>reattach soft tissue, such as<br>ligaments, tendons, or joint<br>capsules to the bone. The<br>suture anchor system<br>thereby stabilizes the<br>damaged soft tissue, in<br>conjunction with<br>appropriate postoperative<br>immobilization,<br>throughout the healing | The device may be used in<br>either arthroscopic or open<br>surgical procedures. After<br>the suture strands are<br>anchored to the bone, they<br>may be used to reattach<br>soft tissue, such as<br>ligaments, tendons or joint<br>capsules to the bone. In<br>conjunction with<br>appropriate post-operative<br>immobilization throughout<br>the healing period, the<br>suture anchor systems<br>stabilize the damaged soft | | | period. | period. | tissue | | Contraindications | 1. Pathological<br>conditions of<br>bone which<br>would adversely<br>affect the<br>CuffLink Implant<br>System.<br>2. Pathological<br>conditions in<br>the soft tissue<br>to be repaired | 1. Pathological<br>conditions of<br>bone which<br>would adversely<br>affect the<br>CrossFT Knotless<br>Suture Anchor.<br>2. Pathological<br>conditions in<br>the soft tissue<br>to be repaired | 1. Pathological<br>conditions of<br>bone which<br>would adversely<br>affect the Y-Knot<br>Anchors.<br>2. Pathological<br>conditions in<br>the soft tissue<br>to be repaired<br>or | | | or<br>reconstructed<br>which would<br>adversely<br>affect suture<br>fixation.<br>3. Physical conditions<br>that would eliminate,<br>or tend to eliminate,<br>adequate implant<br>support or retard<br>healing.<br>4. Conditions which<br>tend to limit the<br>patient's ability or<br>willingness to<br>restrict activities<br>or follow<br>directions during<br>the healing period.<br>5. Attachment of artificial<br>ligaments or other<br>implants.<br>6. Foreign body<br>sensitivity, known or<br>suspected allergies to<br>implant and/or<br>instrument materials.<br>7. This device is not<br>approved for screw<br>attachment or<br>fixation to the<br>posterior elements<br>(pedicles) of the<br>cervical, thoracic or<br>lumbar spine. | or<br>reconstructed<br>which would<br>adversely<br>affect suture<br>fixation.<br>3. Physical conditions<br>that would eliminate,<br>or tend to eliminate,<br>adequate implant<br>support or retard<br>healing.<br>4. Conditions which<br>tend to limit the<br>patient's ability or<br>willingness to<br>restrict activities<br>or follow<br>directions during<br>the healing period.<br>5. Attachment of artificial<br>ligaments or other<br>implants.<br>6. Foreign body<br>sensitivity, known or<br>suspected allergies to<br>implant and/or<br>instrument materials.<br>7. This device is not<br>approved for screw<br>attachment or<br>fixation to the<br>posterior elements<br>(pedicles) of the<br>cervical, thoracic or<br>lumbar spine. | reconstructed<br>which would<br>adversely<br>affect suture<br>fixation.<br>3. Physical conditions<br>that would eliminate,<br>or tend to eliminate,<br>adequate implant<br>support or retard<br>healing.<br>4. Conditions which<br>tend to limit the<br>patient's ability or<br>willingness to<br>restrict activities<br>or follow<br>directions during<br>the healing period.<br>5. Attachment of artificial<br>ligaments or other<br>implants.<br>6. Foreign body<br>sensitivity, known or<br>suspected allergies to<br>implant and/or<br>instrument materials.<br>7. This device is not<br>approved for screw<br>attachment or<br>fixation to the<br>posterior elements<br>(pedicles) of the<br>cervical, thoracic or<br>lumbar spine.<br>8. Patients with active<br>sepsis or infection. | | How Supplied | Sterile, Kit (anchor<br>implants, instrumentation,<br>suture) | | Sterile anchor with delivery system | | Reuse/Sterilization | Single-Use | | | | Shelf-Life | 18 month | | 5-years | | Principle of<br>Operation | | For soft tissue to bone fixation | | | Biocompatibility | In accordance with ISO 10993-1 and FDA# G95-1 | | | | Packaging | Multiple implants<br>packaged in a tray to | Packaged as a single device | | {5}------------------------------------------------ Image /page/5/Picture/1 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, the word "CONMED" is written in a bold, black font. Below the word "CONMED", the word "CORPORATION" is written in a smaller, gray font. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for Conmed Corporation. The logo features a blue, stylized "C" shape on the left. To the right of the "C" is the word "CONMED" in a bold, sans-serif font, with a horizontal line underneath. Below the line is the word "CORPORATION" in a smaller, sans-serif font. | | include a broaching punch<br>and Hi-Fi Suture | | | |-----------|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|-----------------------------------------------------------------| | Materials | PEEK Optima, UHMWPE,<br>polyester, and nylon<br>suture, stainless steel,<br>polycarbonate | PEEK Optima, UHMWPE<br>suture, stainless steel,<br>polycarbonate, nitinol | UHMWPE, polyester, and<br>nylon suture tape, stainless<br>steel | #### VI. PERFORMANCE DATA Testing has been completed to demonstrate that the Cufflink Implant System performs as intended and is substantially equivalent to the predicate device. The bacterial endotoxin testing was conducted and met the limits. Completed test data includes the following: - Biocompatibility - - Packaging - - User Validation - - Shelf-life — - -Sterilization - -Transportation - Pyrogenicity - #### VII. CONCLUSION CONMED's Cufflink Implant System is either substantially equivalent or identical in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the CrossFT Knotless Suture Anchor w/Disposable Driver. Based upon the findings of our performance testing, the differences present no new issues of safety and is substantially equivalent to the predicate device.