FAST-FIX FLEX

{0}------------------------------------------------ Image /page/0/Picture/0 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, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 1, 2021 Smith & Nephew, Inc. Crystal Morales Regulatory Affairs Specialist II 7135 Goodlett Farms Parkway Cordova, Tennessee 38016 Re: K203393 Trade/Device Name: Fast-fix Flex Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: December 4, 2020 Received: December 7, 2020 Dear Ms. Morales: 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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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 medical devices and radiation-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, Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K203393 Device Name FAST-FIX FLEX Indications for Use (Describe) The FAST-FIX FLEX Meniscal Repair System is indicated for use in meniscal repairs, allograft transplant procedures, and anchoring the allograft to the meniscal rim during allograft transplant procedures. Type of Use (Select one or both, as applicable) X 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}------------------------------------------------ Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810 Massachusetts, USA T:+ 1 978 749 1000 T:+ 1 800 343 8386 (USA toll free) www.smith-nephew.com # 510(k) Summary Prepared: 26 January 2021 | Submitter Information | Contact Information | |-----------------------|----------------------------------| | Smith & Nephew, Inc. | Crystal Morales | | Endoscopy Division | Regulatory Affairs Specialist II | | 150 Minuteman Road | Phone: (267)-266-5383 | | Andover, MA 01810 | Fax: (978) 749-1443 | | Device Name & Classification | | |------------------------------|------------------------------------------------| | Proprietary Name | FAST-FIX ® FLEX | | Common Name | Suture Retention Device | | Classification Name | Suture, nonabsorbable, synthetic, polyethylene | | Classification Regulation | 21 CFR §878.5000 | | Class | II | | Product Code(s) | GAT | | Panel | General and Plastic Surgery | ## Legally Marketed Predicate Devices The Smith & Nephew FAST-FIX® FLEX Meniscal Repair System is substantially equivalent in intended use and fundamental scientific technology to the following legally marketed devices in commercial distribution: | Description | Submission Number | Clearance Date | |-------------------------------------------------------|-------------------|----------------| | Smith & Nephew FAST-FIX 360<br>Meniscal Repair System | K121861 | 18 OCT 2012 | ## Device Description FAST-FIX® FLEX is comprised of an implant-suture construct incorporating #2-0 nonabsorbable Ultra-high Molecular Weight Polyethylene (UHMWPE) suture having a pre-tied one-way sliding knot between two non-absorbable polyetheretheketone (PEEK) polymer implants. The suture-implant construct is preloaded into a needle delivery inserter. The needle delivery inserter is offered in two device configurations of curved and reverse curved, whose needle can be modified by the end user with a supplied Bend Tool. The Bend Tool is a sterile, single use optional non-measuring accessory intended to control the bend radius and limit the bend angle to ensure reliable deployment of implants after modification. A sterile, single use slotted cannula is also supplied with the system. {4}------------------------------------------------ #### Intended Use The FAST-FIX FLEX is indicated for use in meniscal repairs, allograft transplant procedures, and anchoring the allograft to the meniscal rim during allograft transplant procedures. The Indications for Use statement for FAST-FIX FLEX is different from that of the predicate device FAST-FIX 360 Meniscal Repair System (K121861). The differences are for clarification of content and does not impact the intended use of the device nor the safety and effectiveness of the device in relation to the predicate. As with the predicate device, the Smith & Nephew FAST-FIX FLEX Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures. #### Technological Characteristics The Smith & Nephew FAST-FIX® FLEX and predicate device FAST-FIX 360 Meniscal Repair System (K121861) uses an all-inside technique through an arthroscopic portal to allow surgeons to reduce tears. The devices use identical suture-implant construct materials that is preloaded into a needle delivery inserter. Differences in technological characteristics of FAST-FIX FLEX in comparison to the predicate device include, distal needle curvature adjustment with a supplied bend tool, smaller suture bar implants for less disruption to soft tissue and design feature modification to improve implant retention. The Smith & Nephew FAST-FIX FLEX is substantially equivalent in intended use and fundamental scientific technology as the legally marketed predicate device and raise no new questions of safety and efficacy. ## Summary Performance Data The nonclinical performance data provided in the premarket notification in support of substantial equivalence included biocompatibility testing, sterilization evaluation, implant repair testing, implant bridge strength, tensile strength through cyclic loading and implant failure testing. The biocompatibility of the FAST-FIX FLEX was evaluated against the requirements per ISO 10993-1:2018. Evaluation included assessment of existing data, chemical characterization, and cytotoxicity, which provided framework for requiring additional endpoint testing. All acceptance criteria were met and FAST-FIX FLEX was deemed biologically safe. Sterilization validation methods of FAST-FIX FLEX was compared to the predicate device FAST-FIX 360 Meniscal Repair System (K121861) to demonstrate suitability of the subject device for terminal sterilization under the same conditions. The performance data demonstrates that FAST-FIX® FLEX met performance specifications for implant repair and implant bridge strength and met performance specifications for tensile strength through cyclic loading and implant failure testing based on established acceptance {5}------------------------------------------------ criteria and in comparison to the predicate device FAST-FIX 360 Meniscal Repair System (K121861). Therefore, the FAST-FIX FLEX is considered substantially equivalent to the currently marketed predicate. # Substantial Equivalence Information The substantial equivalence of the FAST-FIX® FLEX is based on similarities in indications for use, general design features, operational principles, material biocompatibility and composition, and performance to the predicate, FAST-FIX 360 Meniscal Repair System (K121861). Based on the similarities to the predicate, the FAST-FIX FLEX is equivalent to its predicates.