Acumed Ankle Syndesmosis Repair System

{0}------------------------------------------------ January 7, 2022 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Acumed LLC Janki Bhatt Regulatory Affairs Lead 5885 NE Cornelius Pass Road Hillsboro, Oregon 97124 Re: K212990 Trade/Device Name: Acumed Ankle Syndesmosis Repair System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN, HTW, LXH Dated: December 8, 2021 Received: December 9, 2021 Dear Janki Bhatt: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Limin Sun, Ph.D. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. Submission Number (if known) K212990 Device Name Acumed Ankle Syndesmosis Repair System Indications for Use (Describe) The Acumed Ankle Syndesmosis Repair System is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. Specifically, the Acumed Ankle Syndesmosis Repair System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures. 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. 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}------------------------------------------------ | Date: January 7, 2022 | | 510(k) Summary | | K212990 (Page 1 of 2) | |-----------------------|--|----------------|--|-----------------------| |-----------------------|--|----------------|--|-----------------------| | Contact Details | 21 CFR 807.92(a)(1) | |-----------------------------|--------------------------------------------------------------| | Applicant Name | Acumed LLC | | Applicant Address | 5885 NE Cornelius Pass Road Hillsboro OR 97124 United States | | Applicant Contact Telephone | 503-718-8753 | | Applicant Contact | Ms. Janki Bhatt | | Applicant Contact Email | janki.bhatt@acumed.net | | Device Name | 21 CFR 807.92(a)(2) | |---------------------|-----------------------------------------------------------------------------| | Device Trade Name | Acumed Ankle Syndesmosis Repair System | | Common Name | Single/multiple component metallic bone fixation appliances and accessories | | Classification Name | Washer, Bolt Nut | | Regulation Number | 888.3030 | | Product Code | HTN | | Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |------------------------------------|---------------------| |------------------------------------|---------------------| | Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |-------------|----------------------------------------------------------|--------------| | K043248 | Arthrex TightRope Syndesmosis Device | HTN | | K112111 | 3.5mm Quick Release Drill | HTW | | K133469 | 2.8mm Quick Release Drill | LXH | | Device Description Summary | 21 CFR 807.92(a)(4) | |----------------------------|---------------------| |----------------------------|---------------------| The Acumed Ankle Syndesmosis Repair System is intended to provide fixation during the healing process following a syndesmotic trauma. The Acumed Ankle Syndesmosis Repair System contains a fibula button, a tibia button and a high strength fiber suture assembled onto a driver, and is provided in a sterile kit as two options, one with and one without a drill. The system also offers optional washers in a separate sterile kit. The driver and drill are part of the sterile kits and are not available individually. The metal implants including the buttons and washers are manufactured from Titanium Alloy (Ti 6AL-4V ELI per ASTM F136) and the suture is manufactured from ultra-high-molecular-weight polyethylene (UHMWPE). | Intended Use/Indications for Use | 21 CFR 807.92(a)(5) | |----------------------------------|---------------------| |----------------------------------|---------------------| The Acumed Ankle Syndesmosis Repair System is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. Specifically, the Acumed Ankle Syndesmosis Repair System is intended to provide fixation during the healing process following a {4}------------------------------------------------ ## Indications for Use Comparison 21 CFR 807.92(a)(5) The Acumed Ankle Syndesmosis Repair System has been compared to the Arthrex Tight Rope Syndesmosis Device within this 510(k) submission. The basis of substantial equivalence for the predicate device is their similarities in intended use, material, technology, operating principles, anatomical site for implantation, performance, and design. The analysis of differences between the subject device and predicate device supports substantial equivalence as the differences do not constitute a new intenced use, and the information included within the subject device is che subject device is comparable to the predicate device and does not raise different questions of safety or effectiveness. The Acumed Ankle Syndesmosis Repair System has the same indications for use as the Arthrex TightRope Syndesmosis System. Both have two buttons and a suture intended for a flexible fixation between the distal tibia and fibula across the ankle syndesmosis. Both the predicate and subject devices are intended for single use only. ### Technological Comparison 21 CFR 807.92(a)(6) The subject device has the same technological characteristics as the predicate and subject devices make use of a suture to provide flexible flxation between the buttons located on the outer cortices of the distal tibia and fibula. Both the subject and predicate device deposit the tibial button on the outer through a bone hole that has been drilled from the lateral side. Although the mechanism of deposit varies between the predicate and subject devices, the final construct of the implant placement is the same between the predicate and subject devices The Acumed Ankle Syndesmosis Repair System buttons are material as the buttons in the Arthrex TightRope Syndesmosis Device, titanium alloy (Ti-6Al-4) per ASTM F136), Both predicate and subject devices make use of a UHMWE suture. The subject device incorporates the same basic design as the predicate device, a tibial button is configured in an oblong shape to be passed through a 3.5 mm drill hole to be installed on the outer tibial cortex with two flat wings on elther side of a suture retaining feature. In each device, the fibula button is configured in a primarily round design to be installed on the outer and is sized to be compatible with various plates used in fibula fracture fixation. The dimensions of each button are comparable, resulting in no difference in performance between the predicate and subject devices . Some minor differences exist in the basic shape, design, and technology; however, the performance evaluation demonstrates that the subject device is equivalent to the predicate device # Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) Static and Dynamic fatigue testing was conducted to demonstrate that the Syndesmosis Repair System performs statistically equivalent to the predicate device, Arthrex TightRope Syndesmosis System cleared under K043248. Additionally, insertion testing was done to confirm that the subject device performed adequately per the indication. MRI force, torque, and image artifact testing were conducted in accordance with ASTM F2052 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment, ASTM F21 19 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants, ASTM F2182 Standard Test Method for Measurement of Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging and ASTM F2213 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment. Endotoxin testing (LAL and MMP) was conducted and met the requirement of < 20 EU/device. Shelf-life was confirmed by performing accelerated aging per ASTM F1980, followed by performance evaluation of the aged device and packaging. Clinical testing was not required to support substantial equivalence. (Not Applicable) Based on the results of the nonclinical bench testing described above, it was concluded that the subject and predicate devices are equivalent in performance specifically for the intention in one the subject device was proven to be safe and effective for the indication.