Megaloop Button System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is a circular emblem with an abstract design. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a smaller font size below. May 3, 2024 Suzhou Endophix Co., Ltd. Juan Wu Regulatory Affairs Specialist No. 151, Fengli Road, SIP Suzhou, Jiangsu 215000 China Re: K232941 Trade/Device Name: Megaloop Button System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, HTN Dated: April 3, 2024 Received: April 3, 2024 Dear Juan Wu: 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 (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 available 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. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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). {2}------------------------------------------------ Sincerely, Image /page/2/Figure/3 description: The image shows a digital signature of Jesse Muir. The signature includes the name "Jesse Muir -S" in a large font. The signature also includes the text "Digitally signed by Jesse Muir -S Date: 2024.05.03 13:44:55 -04'00'". Jesse Muir, 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 {3}------------------------------------------------ # Indications for Use Submission Number (if known) K232941 Device Name Megaloop Button System #### Indications for Use (Describe) Megaloop Button System - Megaloop Button with Megaloop Adjustable Loop The device is intended to be used for fixation of bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. For example, ACL/PCL repair and reconstruction. Megaloop Button System - Megaloop AD Device The device is intended to be used for fixation of bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. For example, ACL/PCL repair and reconstruction. Megaloop Button System - Megaloop FLB Device, Megaloop FLW Device, Megaloop XL Button Megaloop FLB Device and Megaloop FLW Device are used for fixation of soft tissue to bone in orthopedic procedures such as ACL repair. When used in conjunction with the Megaloop FLB Device or Megaloop FLW Device, the Megaloop XL Button is intended for fixation of soft tissue to bone in orthopedic procedures such as ACL repairs. Megaloop Button System - Megaloop DB Device, Megaloop AC Button with Megaloop Adjustable Loop The Megaloop DB Device and Megaloop AC Button are 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 Megaloop DB Device 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. - The Megaloop AC Button is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions. 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. Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. {4}------------------------------------------------ # 510(k) Summary # I Submitter Device submitter: Suzhou Endophix Co., Ltd. NO.151, Fengli Road, SIP, 215000 Suzhou, Jiangsu Province PEOPLE'S REPUBLIC OF CHINA | Primary contact person: | Juan Wu<br>Regulatory Affairs Specialist<br>Phone: +86-17521559984<br>Email: Juan.Wu@microport.com | |---------------------------------|----------------------------------------------------------------------------------------------------| | Date of preparation: 2023-09-18 | | # II Device | Trade | Name | of Megaloop Button System | |----------------------|------|-------------------------------------------------| | Device: | | | | Common Name: | | Titanium Button | | Classification Name: | | Fastener, Fixation, Non-degradable, Soft Tissue | | Regulatory Class: | | II | | Product Code: | | MBI, HTN | | Review Panel: | | Orthopedic | | Regulation Number: | | 21 CFR 888.3040, 21 CFR 888.3030 | # III Predicate Devices | Trade Name: | Arthrex PCL Tightrope | |-------------------------|--------------------------------------------------------------------------------------------------| | Common Name: | Fastener, fixation, nondegradable, soft tissue<br>Suture, Nonabsorbable, synthetic, polyethylene | | Classification: | Class II, 21 CFR 888.3040, 21 CFR 878.5000 | | Product Code: | HTY, GAT | | Premarket Notification: | K110123 | | Manufacturer: | Arthrex, Inc. | | Trade Name: | ACL TightRope; ACL TightRope Double Bundle | | Common Name: | Pin, fixation, smooth<br>Suture, Nonabsorbable, synthetic, polyethylene | | Classification: | Class II, 21 CFR 888.3040<br>21 CFR 878.5000 | | Product Code: | HTY, GAT | | Premarket Notification: | K112990 | | Manufacturer: | Arthrex, Inc. | | Trade Name: | RIGIDLOOP Cortical Fixation System | | Common Name: | Fastener, Fixation, Soft Tissue | | Classification: | Class II, 21 CFR 888.3040 | | Product Code: | MBI | | Premarket Notification: | K130814 | | Manufacturer: | Medos International SARL, part of DePuy Mitek, Inc. | | Trade Name: | RIGIDLOOP™ Titanium Button, RIGIDLOOP™ Cortical<br>Fixation System XL | | Common Name: | Implant<br>Fixation Device | | Classification: | Class II, 21 CFR 888.3040 | | Product Code: | MBI | | Premarket Notification: | K190774 | | Manufacturer: | Medos International SARL, part of DePuy Mitek, Inc. | | Trade Name: | EndoButton Continous Loop | | Common Name: | Suture Retention Device; Surgical Button; Retention<br>Bridge<br>Polyester Surgical Suture | | Classification: | Class II, 21 CFR 888.3040, 21 CFR 878.5000 | | Product Code: | MBI, GAT | | Premarket Notification: | K980155 | | Manufacturer: | Smith & Nephew, Inc., Endoscopy Division | | Trade Name: | TightRope™ Syndesmosis Device | | Common Name: | Button/Suture | | Classification: | Class II, 21 CFR 888.3030 | | Product Code: | HTN | | Premarket Notification: | K043248 | | Manufacturer: | Arthrex, Inc. | | Trade Name: | TightRope™ Acromioclavicular (AC) | | Common Name: | Button/Suture | | Classification: | Class II, 21 CFR 888.3030 | | Product Code: | HTN | | Premarket Notification: | K052776 | | Manufacturer: | Arthrex, Inc. | {5}------------------------------------------------ {6}------------------------------------------------ #### Reference device | Trade Name: | Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor | |-------------------------|------------------------------------------------------| | Classification: | Class II, 21 CFR 888.3040 | | Product Code: | MBI | | Premarket Notification: | K232725 | | Manufacturer: | Suzhou Endophix Co., Ltd. | ## IV Device description The Megaloop Button System is a family of titanium buttons for the fixation of bone to bone or soft tissue to bone. The system includes a variety of buttons made of Ti-6AI-4V ELI titanium alloy, with or without pre-assembled nonabsorbable loops, sutures and needles. The loops and sutures are offered in non-absorbable Ultra High Molecular Weight Polyethylene (UHMWPE) material. The long straight needles are offered in XM-16 stainless steel material. The sutures and needles are not implantable and are discarded after assisting with button placement. The Megaloop Button System is provided sterile, non-absorbable, for single use only. # V Indications for use Megaloop Button System - Megaloop Button with Megaloop Adjustable Loop The device is intended to be used for fixation of bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. For example, ACL/PCL repair and reconstruction. #### Megaloop Button System - Megaloop AD Device The device is intended to be used for fixation of bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. For example, ACL/PCL repair and reconstruction. # Megaloop Button System - Megaloop FLB Device, Megaloop FLW Device, Megaloop XL Button Megaloop FLB Device and Megaloop FLW Device are used for fixation of soft tissue to bone in orthopedic procedures such as ACL repair. When used in conjunction with the Megaloop FLB Device or Megaloop FLW Device, the Megaloop XL Button is intended for fixation of soft tissue to bone in orthopedic procedures such as ACL repairs. {7}------------------------------------------------ ## Megaloop Button System - Megaloop DB Device, Megaloop AC Button with Megaloop Adjustable Loop The Megaloop DB Device and Megaloop AC Button are 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 Megaloop DB Device is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures. -The Megaloop AC Button is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions. # VI Comparison of technological characteristics with the predicate devices Suzhou Endophix Megaloop Button System has similar technological characteristics and fundamental design as the predicate device. The differences between the subject device and predicate device do not alter suitability of the proposed device for its intended use. Table 1 Substantial equivalence discussion - Megaloop Button with Megaloop Adjustable | Characteristics | Subject<br>(Megaloop Button with<br>Megaloop Adjustable<br>Loop) | Predicate Device<br>K110123, TightRope<br>ABS Button with<br>TightRope ABS Loop | Remarks | |---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------| | Product Code | MBI, HTN | HTY, GAT | Different | | Regulation<br>Number | 21 CFR 888.3030 | 21 CFR 888.3040 | Different | | Regulation<br>Number | 21 CFR 888.3040 | 21 CFR 878.5000 | | | Regulatory<br>Class | Class II | Class II | Identical as<br>predicate<br>device. | | Intended Use | The device is intended to<br>be used for fixation of<br>bone to bone or soft<br>tissue to bone, and is<br>intended as fixation<br>posts, a distribution<br>bridge, or for distributing<br>suture tension over areas<br>of ligament or tendon<br>repair. For example, | The Arthrex PCL<br>TightRope is intended to<br>be used for fixation of<br>bone to bone or soft<br>tissue to bone, and is<br>intended as fixation<br>posts, a distribution<br>bridge, or for distributing<br>suture tension over areas<br>of ligament or tendon | Identical as<br>predicate<br>device. | | | ACL/PCL repair and<br>reconstruction. | repair. For example,<br>ACL/PCL repair and<br>reconstruction. | | | Composition | Button<br>compatible Loop | Button<br>compatible Loop | Identical as<br>predicate<br>device. | | Key Patient<br>Contacting<br>Material | Button: Ti-6Al-4V ELI<br>titanium alloy<br>Loop: UHMWPE | Button: Ti-6Al-4V ELI<br>titanium alloy<br>Loop: UHMWPE | Identical as<br>predicate<br>device. | | Button Type | Standard button with two<br>symmetric slots;<br>Round button with two<br>symmetric slots;<br>Oblong button with two<br>slots. | Standard button with two<br>symmetric slots;<br>Round button with two<br>symmetric slots;<br>Oblong button with two<br>slots. | Identical as<br>predicate<br>device. | | Dimensional<br>Verification | Standard button: 8 mm ×<br>11 mm,<br>Round button: Φ14mm,<br>Oblong button: 3.4 mm ×<br>13 mm<br>Loop length: adjustable,<br>170mm | Standard button: 8 mm ×<br>12 mm,<br>Round button: Φ14mm,<br>Oblong button: 3.4 mm ×<br>13 mm<br>Loop length: adjustable,<br>170mm | Substantially<br>equivalent. | | Sterilization | EO sterilization | EO sterilization | Identical as<br>predicate<br>device. | | Shelf-life | 5 Years | 5 Years | Identical as<br>predicate<br>device. | | Single<br>Use/Reuse | Single Use | Single Use | Identical as<br>predicate<br>device. | | Operating<br>Principle | The loop pass through<br>bone tunnels and allows<br>attachment of the button<br>against the bone cortex. | The loop pass through<br>bone tunnels and allows<br>attachment of the button<br>against the bone cortex. | Identical as<br>predicate<br>device. | | Environment of<br>Use | Hospitals/clinics | Hospitals/clinics | Identical as<br>predicate<br>device | | Characteristics | Subject<br>Device<br>(Megaloop AD Device) | Predicate Device<br>K112990, ACL TightRope<br>RT implant | Remarks | | Product Code | MBI, HTN | HTY, GAT | Different | | Regulation<br>Number | 21 CFR 888.3030<br>21 CFR 888.3040 | 21 CFR 888.3040<br>21 CFR 878.5000 | Different | | Regulatory<br>Class | Class II | Class II | Identical as<br>predicate<br>device. | | Intended Use | The device is intended to<br>be used for fixation of<br>bone to bone or soft<br>tissue to bone, and is<br>intended as fixation<br>posts, a distribution<br>bridge, or for distributing<br>suture tension over areas<br>of ligament or tendon<br>repair. For example,<br>ACL/PCL repair and<br>reconstruction. | The ACL TightRope and<br>ACL TightRope Double<br>Bundle are to be used for<br>fixation of bone to bone<br>or soft tissue to bone, and<br>are intended as fixation<br>posts, a distribution<br>bridge, or for distributing<br>suture tension over areas<br>of ligament or tendon<br>repair.<br>Specifically,<br>Arthrex will be offering<br>these for ACL/PCL repair<br>and reconstruction. | Identical as<br>predicate<br>device. | | Composition | Implantable part: Button,<br>loop<br>Non-implantable part:<br>Sutures | Implantable part: Button,<br>loop<br>Non-implantable part:<br>Sutures | Identical as<br>predicate<br>device. | | Key Patient<br>Contacting<br>Material | Button: Ti-6Al-4V ELI<br>titanium alloy<br>Loop: UHMWPE | Button: Ti-6Al-4V ELI<br>titanium alloy<br>Loop: UHMWPE | Identical as<br>predicate<br>device. | | Button Type | The button is provided<br>with two round holes and<br>one drop type hole | The button is provided<br>with two round holes and<br>one drop type hole | Identical as<br>predicate<br>device. | | Dimensional<br>Verification | Button: $3.4mm\times13mm$<br>Loop length: adjustable,<br>after pretensioning the<br>loop length is 600mm | Button: $3.4mm\times13mm$<br>Loop length: adjustable,<br>after pretensioning the<br>loop length is 540mm | Substantially<br>equivalent. | | Sterilization | EO sterilization | EO sterilization | Identical as | | | | | | | Shelf-life | 5 Years | 5 Years | Identical as<br>predicate<br>device. | | Single<br>Use/Reuse | Single Use | Single Use | Identical as<br>predicate<br>device. | | Operating<br>Principle | The loop pass through<br>bone tunnels and allows<br>attachment of the button<br>against the bone cortex.<br>The sutures assist the<br>button passing through<br>tunnels and ensure<br>flipping of the button. | The loop pass through<br>bone tunnels and allows<br>attachment of the button<br>against the bone cortex.<br>The sutures assist the<br>button passing through<br>tunnels and ensure<br>flipping of the button. | Identical as<br>predicate<br>device. | | Environment of<br>Use | Hospitals/clinics | Hospitals/clinics | Identical as<br>predicate<br>device. | Loop {8}------------------------------------------------ Table 2 Substantial equivalence discussion – Megaloop AD Device {9}------------------------------------------------ K232941 Page 6 of 16 {10}------------------------------------------------ K232941 Page 7 of 16 Table 3 Substantial equivalence discussion – Megaloop FLB Device, Megaloop FLW Device, Megaloop XL Button | Characteristics | Subject<br>Device<br>(Megaloop FLB Device,<br>Megaloop FLW Device,<br>Megaloop XL Button) | Predicate Device | Remarks | | |------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|------------| | | | K130814, RIGIDLOOP™<br>Fixed Loop<br>(primary predicate) | | | | | | K980155, EndoButton<br>CL Ultra<br>K190774, RIGIDLOOP™<br>XL Button<br>(additional predicate) | | | | Product Code | MBI | MBI (K130814)<br>GAT, MBI (K980155)<br>MBI (K190774) | Identical as<br>predicate<br>device. | | | Regulation<br>Number | 21 CFR 888.3040 | 21 CFR 888.3040<br>(K130814)<br>21 CFR 888.3040<br>21 CFR 878.5000 | Identical as<br>predicate<br>device. | | | | | (K980155)<br>21 CFR 888.3040<br>(K190774) | Page 8 of | | | Regulatory<br>Class | Class II | Class II | Identical as<br>predicate<br>device. | | | Intended Use | Megaloop FLB Device<br>and Megaloop FLW<br>Device are used for<br>fixation of soft tissue to<br>bone in orthopedic<br>procedures such as ACL<br>repair.<br><br>When used in conjunction<br>with the Megaloop FLB<br>Device or Megaloop FLW<br>Device, the Megaloop XL<br>Button is intended for<br>fixation of soft tissue to<br>bone in orthopedic<br>procedures such as ACL<br>repairs. | The RIGIDLOOPTM<br>Cortical Fixation System<br>(K130814) is used for the<br>fixation of soft tissue to<br>bone in orthopedic<br>procedures such as ACL<br>repair.<br><br>The EndoButton<br>Continuous Loop<br>(K980155) is used for<br>fixation of tendons and<br>ligaments during<br>orthopedic reconstruction<br>procedures such as<br>Anterior Cruciate<br>Ligament (ACL)<br>Reconstruction.<br><br>When used in<br>conjunction with the<br>RIGIDLOOP Cortical<br>Fixation System, the<br>RIGIDLOOP Cortical<br>Fixation System XL<br>Implant (K190774) is<br>intended for fixation of<br>soft tissue to bone in<br>orthopedic procedures<br>such as ACL repairs. | Identical as<br>predicate<br>device. | | | Composition | Megaloop FLB Device,<br>Megaloop FLW Device<br>Implantable part: Button,<br>Loop | (K130814, K980155)<br>Implantable part: Button,<br>loop<br>Non-implantable part: | Identical as<br>predicate<br>device. | | | | Non-implantable part: Sutures | | Sutures | | | | Megaloop XL Button<br>Implantable part: Button | (K190774)<br>Implantable part: Button | | | | Key<br>Patient<br>Contacting<br>Material | Button: Ti-6Al-4V ELI<br>titanium alloy<br>Loop: UHMWPE | K130814<br>Button: Ti-6Al-4V ELI<br>titanium alloy<br>Loop: UHMWPE<br><br>K980155<br>Button: Ti-6Al-4V ELI<br>titanium alloy<br>Loop: Polyethylene<br>Terephthalate (PET)<br><br>K190774<br>Button: Ti-6Al-4V ELI<br>titanium alloy | Substantially<br>equivalent. | | | Button Type | Megaloop FLB Device,<br>Megaloop FLW Device<br>The button is provided<br>with four round holes<br><br>Megaloop XL Button<br>The button consists of an<br>elongated titanium plate<br>with a recess and two<br>symmetrical lateral slots | (K130814, K980155)<br>The button is provided<br>with four round holes<br><br>(K190774)<br>The button consists of an<br>elongated titanium plate<br>with a recess and two<br>symmetrical lateral slots | Identical as<br>predicate<br>device. | | | Loop Type | Megaloop FLW Device:<br>weaved loop<br><br>Megaloop FLB Device:<br>blended loop | K130814: weaved loop<br><br>K980155: blended loop | Identical as<br>predicate<br>device. | | | Dimensional<br>Verification | Megaloop FLB Device,<br>Megaloop FLW Device<br>Button: 4mm × 12mm<br>Loop length: 15-60mm in<br>5mm increments | K130814<br>Button: 4mm × 12mm<br>Loop length: 15-60mm in<br>5mm increments<br><br>K980155<br>Button width: from 4 to | Substantially<br>equivalent. | | | | | | | Page 10 of | | | | 6mm<br>Button length: from 12 to 18mm<br>Loop length: 10-80 mm | | | | | <b>Megaloop XL Button</b><br>Button: 5.5mm × 20mm | <b>K190774</b><br>Button: 5.5mm × 20mm | | | | Sterilization | EO sterilization | EO sterilization | Identical as predicate device. | | | Shelf-life | 5 Years | 5 Years | Identical as predicate device. | | | Single Use/Reuse | Single Use | Single Use | Identical as predicate device. | | | Operating Principle | <b>Megaloop FLB Device, Megaloop FLW Device</b><br>The loop pass through tunnels and allows attachment of the button against the bone cortex. The sutures assist the button passing through tunnels and ensure flipping of the button. | <b>(K130814, K980155)</b><br>The loop pass through tunnels and allows attachment of the button against the bone cortex. The sutures assist the button passing through tunnels and ensure flipping of the button. | Identical as predicate device. | | | | <b>Megaloop XL Button</b><br>Pass the Megaloop FLB Device or Megaloop FLW Device through the hole in the Megaloop XL Button from the bottom to provide additional width to the Megaloop FLB Device or Megaloop FLW Device. | <b>(K190774)</b><br>Pass the Standard Implant through the hole in the XL Implant from the bottom to provide additional width to the Standard Implant. | | | | Environment of Use | Hospitals/clinics | Hospitals/clinics | Identical as predicate device. | | | Characteristics | Subject<br>Device<br>(Megaloop DB Device) | Predicate Device | Remarks | | | | | K043248,<br>Knotless<br>TightRope™ Syndesmosis<br>Repair Kit | | | | Product Code | HTN…