Fiji Anchor

{0}------------------------------------------------ January 19, 2018 Image /page/0/Picture/1 description: The image shows 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. SportWelding GmbH % Janice M. Hogan Regulatory Counsel Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103 Re: K171228 Trade/Device Name: Fiji 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, HTY, GAT Dated: December 13, 2017 Received: December 13, 2017 Dear Ms. Hogan: 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 quality systems (QS) regulation (21 CFR Part 820); {1}------------------------------------------------ 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about mediation-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, # Katherine D. Kavlock -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 510(k) Number (if known) K171228 Device Name Fiji Anchor Indications for Use (Describe) The Fiji Anchor is intended to be used for suture or tissue fixation in the foot, ankle, hand, wrist, elbow, and shoulder. The Fiji Anchor is designed only to be inserted with the BoneWelder 150-W1 system. Specific indications are listed below: Elbow: Ulnar or Radial Collateral Ligament Reconstruction Shoulder: Bankart Repair, Capsular Shift or Capsulolabral Reconstruction Hand/Wrist: Scapholunate Ligament Reconstruction. Carpal Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers Foot/Ankle: Lateral Stabilization, Metatarsal Ligament Repair, Hallux Valqus reconstruction, digital tendon transfers. Mid-foot reconstruction Type of Use (Select one or both, as applicable) 2 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}------------------------------------------------ ## K171228 ### 510(k) SUMMARY ### SportWelding's Fiji Anchor # Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared Sport Welding GmbH Wagistrasse 6 Schlieren, Switzerland Phone: +41 44 204 61 2821 Facsimile: +41 44 204 61 2820 Contact Person: Joerg Mayer, Managing Director, CTO Date Prepared: January 17, 2018 ### Name of Device and Name Fiji Anchor ### Common or Usual Name Fastener, fixation, biodegradable, soft tissue (MAI), class II Pin, fixation, smooth (HTY), class II Suture, nonabsorbable, synthetic, polyethylene (GAT), class II #### Classification Name Single/multiple component metallic bone fixation appliances and accessories (21 CFR 888.3030) Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040) Nonabsorbable poly(ethylene terephthalate) surgical suture (21 CFR 878.5000) #### Predicate Devices - K063479 Arthrex's Bio-PushLock (Primary) - . K143063 Stryker's SonicAnchor System (Reference) ### Indications for Use The Fiji Anchor is intended to be used for suture or tissue fixation in the foot, ankle, hand, wrist, elbow, and shoulder. The Fiji Anchor is designed only to be inserted with the BoneWelder 150-W1 system. Specific indications are listed below: {4}------------------------------------------------ Elbow: Ulnar or Radial Collateral Ligament Reconstruction Shoulder: Bankart Repair, Capsular Shift or Capsulolabral Reconstruction Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers Foot/Ankle: Lateral Stabilization, Medial Stabilization, Metatarsal Liqament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction # Technological Characteristics The Fiji anchor system consists of an implantable anchor, an ultrasound system, and handpiece tip, and a twist drill. The Fiji Anchor® is made of biocompatible and fully bioresorbable Poly-L-lactide-co-D,Llactide. The in vivo degradation of the Fiji Anchor® is based on the natural physiologic process of hydrolysis, which results in the complete metabolization of the polymer into H₂O and CO2. The Fiji Anchor® is a fully bioresorbable implant designed for soft tissue reattachment to bone by means of suture material. The BoneWelding® technology employs ultrasonic energy to liquefy the polymeric components of the Fiji Anchor® at the interface with bone tissue. The liquid polymer flows into the marrow space of the surrounding cancellous bone where it is immediately quenched and provides anchorage of the implant. The ultrasonic energy for the implantation of the Fiji Anchor® is produced by the BoneWelder® ultrasonic generator and applied via the attached handpiece. The handpiece tip (sonotrode) is mounted on the handpiece. It transmits the ultrasonic energy to the Fiji Anchor®. The twist drill is dedicated to be used with the Fiji Anchor®. #### Performance Data The following tests were performed to demonstrate the substantial equivalence of the Fiji Anchor: - Software documentation and validation per FDA guidance - . IEC 60601-1 and 60601-1-2 testing - . Material characterization using GPC, inherent viscosity, GCMS, and ICP - . Static pullout testing before and after aging - . Dynamic pullout testing before and after aging - Creep testing - . Extraction and analysis per ISO 10993-18 {5}------------------------------------------------ - Cytotoxicity testing per ISO 10993-5 . - . Temperature rise in surrounding bone (porcine bone) - . Lot-to-lot endotoxin testing is also performed per USP <85> # Substantial Equivalence The Fiji Anchor is as safe and effective as the Arthrex's Bio-PushLock. The Fiji Anchor has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Fiji Anchor and its predicate devices, summarized in the table below, raise no new issues of safety or effectiveness. Performance data demonstrate that the Fiji Anchor is as safe and effective as Arthrex's Bio-PushLock. Thus, the Fiji Anchor is substantially equivalent. | Property | SportWelding Fiji | Arthrex 2.5 mm Bio- | Stryker Sonic Anchor | |--------------------------------------------|-------------------------------------------------------------------------|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------| | | Anchor | PushLock | | | 510(k) | Subject | K063497 | K143063 | | Components | Anchor, suture, | PEEK eyelet, suture, | Anchor, suture, | | | sonotrode, US generator | anchor | sonotrode, US generator | | Size | 2.3 x 7.2 mm | 2.5 x 8 mm | 2.5 x 12 mm | | Suture Sizes | #4-0, #3-0, #2-0, #0, #2 | #2-0, #0 | #2-0, #0, #2 | | Insertion Method | Insert anchor into<br>predrilled hole while<br>applying US energy | Insert eyelet into<br>predrilled hole, then<br>secure with<br>bioresorbable anchor | Partially insert anchor<br>into predrilled hole, then<br>fully insert while<br>applying US energy | | Fixation Method | Ultrasonic melting of the<br>polymer into the porous<br>cancellous bone | Barbs in a mechanical<br>press-fit | Ultrasonic melting of the<br>polymer into the porous<br>cancellous bone | | Length of<br>ultrasound<br>energy delivery | Not more than 6<br>seconds | N/A | Not more than 12<br>seconds | | Suture fixation | Manual knotting | Knotless | Manual knotting | | Material | PLDLLA | PLLA and PEEK | PLDLLA | | Resorbable | Yes | Partly | Yes | | Sterilization | Sterile | Sterile | Sterile | # Conclusions The Fiji Anchor is substantially equivalent to the predicate device.