Arthrex SwiveLock Anchor

{0}------------------------------------------------ April 19, 2021 Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left and features a stylized eagle. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. Arthrex Inc. Kelsey Roberts Regulatory Affairs Specialist II 1370 Creekside Boulevard Naples, Florida 34108 Re: K203495/S001 Trade/Device Name: Arthrex SwiveLock Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: MAI, MBI Dated: March 15, 2021 Received: March 16, 2021 Dear Kelsey Roberts: 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ 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. # Laura C. Rose -S Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K203495 Device Name Arthrex SwiveLock Anchor Indications for Use (Describe) The Arthrex SwiveLock Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in skeletally mature pediatric and adult patients for the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis Capsulolabral Reconstruction, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulo labral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament/Tendon Repair, and Bunionectomy Knee: Anterior Cruciate Ligament Repair (4.75- 5.5 SwiveLock Only), Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair (4.75 SwiveLock C Only), Meniscal Root Repair (4.75 SwiveLock C Only), Secondary or adjunct fixation for ACL/PCL reconstruction or repair (4.75-5.5 SwiveLock only), MPFL Repair/Reconstruction(3.9 SwiveLock Only) Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/Radial Collateral Ligament Reconstruction Elbow: Biceps Tendon Reattachment, Unar/Radial Collateral Ligament Reconstruction, and Lateral Epicondylitis repair Hip: Capsular Repair, Acetabular labral repair, Gluteus Medius Repair (4.75 – 5.5 mm PEEK SwiveLock suture anchors only), and Proximal Hamstring Repair (4.75 - 5.5 mm PEEK SwiveLock suture anchors only). | 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, {3}------------------------------------------------ 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." {4}------------------------------------------------ ## 510(k) Summary | Date Prepared | March 10, 2021 | |--------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter | Arthrex Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 | | Contact Person | Kelsey N. Roberts<br>Regulatory Affairs Associate Specialist<br>1-239-643-5553, ext. 72257<br>Kelsey.Roberts@arthrex.com | | Name of Device | Arthrex SwiveLock Suture Anchor | | Common Name | Suture Anchor | | Product Code(s) | MAI<br>MBI | | Classification Name(s) | 21 CFR 888.3040: Smooth or threaded metallic bone fastener<br>21 CFR 888.3030: Single/multiple component metallic bone fixation appliances and<br>accessories | | Regulatory Class | II | | Predicate Device(s) | K191226: Arthrex SwiveLock Suture Anchor<br>K201749: Arthrex SwiveLock Anchor | | Reference Device(s) | K173240: Arthrex PushLock<br>K173845: Arthrex SwiveLock<br>K190728 - Arthrex SwiveLock Anchors<br>K192441- Arthrex SwiveLock Anchors<br>K143745 – Arthrex Corkscrew and SwiveLock Suture Anchors | | Purpose of Submission | This premarket notification is submitted to obtain pediatric indications for the<br>Arthrex SwiveLock Suture Anchors cleared under K191226 and K201749. | | Device Description | The Arthrex SwiveLock Anchor is a sterile two-component suture anchor comprised of<br>an eyelet and a hollow anchor body. The Arthrex SwiveLock Anchor is pre-mounted<br>on a driver with an anchor body and eyelet physically separated on the driver shaft.<br>Arthrex 510(k) cleared suture may also be provided with the device. | | Comparison Summary<br>of Technological<br>Characteristics and<br>Modifications<br>Proposed | The proposed devices have the same technological characteristics (device design,<br>sterilization, and biocompatibility). The proposed device modification consists of the<br>additional patient population including pediatric patients in skeletally mature bone<br>and an extended shelf life. | | Indications for Use | The Arthrex SwiveLock Anchor is intended for fixation of suture (soft tissue) to bone<br>in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in skeletally mature<br>pediatric and adult patients for the following procedures:<br><br>Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis<br>Capsulolabral Reconstruction, Acromio-Clavicular Separation Repair, Deltoid Repair,<br>Capsular Shift or Capsulo labral Reconstruction.<br><br>Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux<br>Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament/Tendon<br>Repair, and Bunionectomy | | | Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior<br>Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair (4.75<br>SwiveLock C Only), Meniscal Root Repair (4.75 SwiveLock C Only), Secondary or<br>adjunct fixation for ACL/PCL reconstruction or repair (4.75-5.5 SwiveLock only), MPFL<br>Repair/Reconstruction(3.9 SwiveLock Only) | | | Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/Radial Collateral<br>Ligament Reconstruction | | | Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament<br>Reconstruction, and Lateral Epicondylitis repair | | | Hip: Capsular Repair, Acetabular labral repair, Gluteus Medius Repair (4.75 - 5.5 mm<br>PEEK SwiveLock suture anchors only), and Proximal Hamstring Repair (4.75 - 5.5 mm<br>PEEK SwiveLock suture anchors only). | | Performance Data | Ultimate load testing and cyclic displacement was performed on the subject device<br>and compared to the predicate device to demonstrate that the modifications do not<br>negatively impact mechanical strength. | | | Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate that the<br>device meets pyrogen limit specifications. | | Clinical Literature | Clinical literature was provided on the subject devices involving the proposed patient<br>population of skeletally mature pediatric patients. The reviewed literature shows the<br>device is effective when used in the proposed patient population with skeletally<br>mature bone. | | Real World<br>Data/Evidence | Real World Data/Evidence is provided from the Surgical Outcomes System registry.<br>Based on the patient outcomes, there are no statistical differences in patients less 22<br>years of age versus patients greater than 22 years of age. | | Conclusion | The Arthrex SwiveLock Suture Anchors are substantially equivalent to the predicate<br>devices in which the basic design features and intended use are the same. Any<br>differences between the Arthrex proposed device and the predicate device are<br>considered minor and do not result in new or different questions of safety or<br>effectiveness. Based on the indications for use, technological characteristics, and the<br>summary of data submitted, Arthrex Inc. has determined that the proposed device is<br>substantially equivalent to the currently marketed predicate device. | {5}------------------------------------------------