SECURE-LOCK

{0}------------------------------------------------ July 22, 2022 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 the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Xiros Ltd. Steve Curran Compliance Director Springfield House Lane, Whitehouse Lane Leeds, West Yorkshire LS17 7UE United Kingdom #### Re: K220906 Trade/Device Name: SECURE-LOCK Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY, GAT Dated: June 16, 2022 Received: June 21, 2022 Dear Steve Curran: 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 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, 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}------------------------------------------------ | DEPARTMENT OF HEALTH AND HUMAN SERVICES | |-----------------------------------------| | Food and Drug Administration | #### Indications for Use 510(k) Number (if known) K220906 Device Name SECURE-LOCK Indications for Use (Describe) The SECURE-LOCK is indicated for fixation of bone or soft tissue to bone, and is intended as a fixation device, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair such as Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) Repair and Reconstruction. 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) Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. #### 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." FORM FDA 3881 (6/20) PSC Publishing Services (101) 443-6740 ESF {3}------------------------------------------------ Ltd. Springfield Hou Whitehouse La Leeds LS19 7UF UK Tel. +44 (0) 113 238 7200 Fax. +44 (0) 113 238 7201 enquiries@xiros.co.uk www.xiros.co.uk Image /page/3/Picture/3 description: The image shows a logo for Xiros. The logo features the word "XIROS" in bold, sans-serif font, placed inside a rounded, rectangular shape. The shape is colored in a teal or dark green hue. To the right of the rounded rectangle, there is a white, stylized branching shape, possibly representing a network or connection. The background is a light gray or muted green color. 510(k) Summary K220906 In accordance with 21 CFR 807.92, the following information constitutes a 510(k) summary for SECURE-LOCK, Suspensory Fixation Device for ACL/PCL. # Submitter Information Xiros Ltd 510(k) Submitter: Address: Springfield House Whitehouse Lane Leeds LS19 7UE UK Telephone: +44 (0)113 238 7200 Fax: +44 (0)113 2387201 Contact (primary correspondent) Name: Dr. Steve Curran Title: Compliance Director Email: CFS@xiros.co.uk Date summary was prepared: July 22, 2022 # Device Identification Name of device: Trade Name: Model number(s): Common Name: Classification: Regulation and Classification Name: Classification Panel: Product Code: Pin, Fixation, Smooth / Suture, nonabsorbable, synthetic, polyethylene Class II 21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener 21 CFR 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture Orthopedic HTY/ GAT # Purpose of Submission The purpose of this submission is to obtain clearance for a new orthopedic fixation device for use in the fixation of bone to bone and soft tissue to bone. SECURE-LOCK SECURE-LOCK 102-1377 {4}------------------------------------------------ # Predicate Device Information The SECURE-LOCK Suspensory Fixation Device for ACL/PCL described in this submission is substantially equivalent to the following predicate device: - Arthrex ACL Tightrope (K112990) - # Reference Device - XTREME-LOOP (K191053) The device uses identical Titanium alloy and -UHMWPE materials, an identical Flipping suture and the same sterilization process to the SECURE-LOCK. - -SECURE-LOOP (K151601) - The device uses identical Polyester materials in the suture components (Implant Loop, Pulling and Flipping sutures) and the same sterilization process to the SECURE-LOCK. # Device Description The SECURE-LOCK fixation device consists of a sterile and non-absorbable polyester and ultrahigh molecular weight polyethylene blended braid that forms a loop on a titanium alloy button. The button sits on the cortex over the exit to a bone tunnel, suspending the loop inside the tunnel to provide secure, strong fixation for ligament repair and reconstruction. The SECURE-LOCK fixation device is supplied with polyester sutures that are used to assemble and deliver the device. #### Intended Use The SECURE-LOCK is indicated for fixation of bone or soft tissue to bone, and is intended as a fixation device, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair such as Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) Repair and Reconstruction. #### Comparison of Technological Characteristics with the Predicate Device The SECURE-LOCK has the same basic principles of operation as the predicate device. They both consist of an implantable, titanium alloy button that sits on the exit to a bone tunnel on the cortex, suspending a non-absorbable loop inside a tunnel to provide secure, strong fixation for ligament repair/reconstruction. Both devices utilize sutures to deliver the implant into the body with the only difference being the number of sutures used. Both devices utilize the same core materials, with only minor differences in the material composition of each device component. Any differences are considered minor and do not raise questions concerning safety and effectiveness. # Performance Data The following performance testing has been completed for the SECURE-LOCK: - Implant Tensile Strength Tests ● - Implant Fatigue Tests ● - Pulling Suture Tensile Strength Tests ● - Suture Diameter Measurements and Tensile Strength - Formal assessment of the SECURE-LOCK design in simulated use conditions - MRI Compatibility - Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) - Biocompatibility testing in accordance with ISO 10993-1 {5}------------------------------------------------ Bacterial endotoxin testing was performed on representative devices, the XTREME-LOOP (K191053) and SECURE-LOOP (K151601) that, together, are identical in materials, formulation, sterilization process and manufacturing facilities to the subject device implantable components. The devices have been tested for pyrogenicity using the Limulus Amoebocyte Lysate (LAL) method in line with the requirements of ANSI/AAMI ST72. The devices were found to have a result that met the FDA requirements of < 20 EU/Device. Final product batch release testing for endotoxins will be carried out on the subject device in accordance with ANSI/AAMI ST72:2019. In addition, the SECURE-LOCK has been tested for rabbit materialmediated pyrogenicity in line with USP <151>, and meets the pyrogen specification limits for this test. These tests have been conducted in accordance with the following Guidance documents and applicable FDA recognized consensus standards, relevant to the device: - Surgical Sutures Class II Special Controls Guidance Document for Industry and FDA -Staff - Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in -Orthopedic Devices - Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) -Environment - 6-467 USP-NF M80200 04 01 Nonabsorbable Surgical Suture - - 6-468 USP-NF M99670 02 01 <881> Tensile Strength - - 6-469 USP-NF M99650 02 01 <861> Sutures Diameter - - Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices -Part-1": Evaluation and Testing within a risk management process #### Conclusion The intended use of SECURE-LOCK is substantially equivalent to the predicate, Arthrex ACL Tightrope. SECURE-LOCK has the same basic principles of operation and core materials as the predicate. Any differences identified between the subject and predicate device are minor and do not present safety and effectiveness concerns. The performance testing results demonstrate that the SECURE-LOCK provides appropriate mechanical properties and is relatively safe for its use in the fixation of bone to bone and soft tissue to bone. The performance data benefit/risk analysis concluded that the differences encountered do not affect the safety and efficacy of the new device in relation to the predicate. The SECURE-LOCK device is substantially equivalent to the Arthrex ACL Tightrope (K112990) for use in fixation of bone to bone and soft tissue to bone. Image /page/5/Picture/14 description: The image shows a collection of logos and emblems. These include the British Safety Council, Investors in People (with a "Good Practice" designation and a "Health & Wellbeing Award"), a "3 Star Customer" emblem from 2019, The Queen's Awards for Enterprise International Trade 2016, Investors in People Gold, and a BSI ISO 13485 Medical Devices Quality Management System emblem with the code MD 85983. The text "Registered in England No. 1664824" is also present.