Who is the manufacturer of Megaloop Button System?

Suzhou Endophix Co., Ltd. filed the 510(k) submission for Megaloop Button System (K232941).

What is the FDA product code for Megaloop Button System?

MBI. It is classified under 21 CFR 888.3040 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for Megaloop Button System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Megaloop Button System?

Arthrex PCL Tightrope (K110123); ACL TightRope; ACL TightRope Double Bundle (K112990); RIGIDLOOP Cortical Fixation System (K130814); RIGIDLOOP Titanium Button, RIGIDLOOP Cortical Fixation System XL (K190774); EndoButton Continous Loop (K980155); TightRope Syndesmosis Device (K043248); TightRope Acromioclavicular (AC) (K052776).

Who can help prepare an FDA 510(k) submission like Megaloop Button System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Megaloop Button System

K232941 · Suzhou Endophix Co., Ltd. · MBI · May 3, 2024 · Orthopedic

Device Facts

Record ID	K232941
Device Name	Megaloop Button System
Applicant	Suzhou Endophix Co., Ltd.
Product Code	MBI · Orthopedic
Decision Date	May 3, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3040
Device Class	Class 2
Attributes	Therapeutic

Intended 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. 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.

Device Story

Megaloop Button System comprises titanium buttons (Ti-6Al-4V ELI) and UHMWPE loops for orthopedic soft tissue-to-bone fixation. Buttons are passed through bone tunnels via attached sutures/needles; loops allow button attachment against bone cortex. Used in hospitals/clinics by surgeons for ACL/PCL reconstruction and fracture repair. System provides mechanical fixation during healing. Benefits include secure tissue/bone stabilization. Non-implantable sutures/needles are discarded post-placement.

Clinical Evidence

Bench testing only. Includes pullout and fatigue mechanical testing compared to Arthrex ACL TightRope RT. Biocompatibility evaluated per ISO 10993-1. Sterilization validated per ISO 11135 (SAL 10^-8). Shelf-life validated via accelerated aging.

Technological Characteristics

Materials: Ti-6Al-4V ELI (ISO 5832-3) and UHMWPE (ASTM F2848-17). Mechanical fixation via cortical buttons and adjustable loops. Sterilization: Ethylene Oxide (EO). Single-use, sterile. No software or electronic components.

Indications for Use

Indicated for fixation of bone-to-bone or soft tissue-to-bone in orthopedic procedures, including ACL/PCL repair and reconstruction, syndesmotic trauma (Weber B/C ankle fractures), and acromioclavicular separations. Used as fixation posts, distribution bridges, or for suture tension distribution in fracture repair where screws are not indicated.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

Arthrex PCL Tightrope (K110123)
ACL TightRope; ACL TightRope Double Bundle (K112990)
RIGIDLOOP Cortical Fixation System (K130814)
RIGIDLOOP Titanium Button, RIGIDLOOP Cortical Fixation System XL (K190774)
EndoButton Continous Loop (K980155)
TightRope Syndesmosis Device (K043248)
TightRope Acromioclavicular (AC) (K052776)

Reference Devices

Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor (K232725)

Related Devices

K202291 — Button Loop · Yunyi (Beijing) Medical Device Co., Ltd. · Jan 8, 2021
K233552 — IDEAL Ziploop · Riverpoint Medical · Nov 30, 2023
K253695 — LigaMend · Riverpoint Medical, LLC · Feb 27, 2026
K070780 — CONMED LINVATEC XO BUTTON · Conmed Linvatec · Aug 21, 2007
K232886 — INFILOOP® Fixed Loop UHMWPE Suture Titanium Button · Healthium Medtech Limited · Nov 8, 2023

Submission Summary (Full Text)

{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 Regulatory Affairs Specialist Phone: +86-17521559984 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 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 Suture, Nonabsorbable, synthetic, polyethylene | | Classification: | Class II, 21 CFR 888.3040 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 Fixation System XL | | Common Name: | Implant 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 Bridge 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 (Megaloop Button with Megaloop Adjustable Loop) | Predicate Device K110123, TightRope ABS Button with TightRope ABS Loop | Remarks | |---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------| | Product Code | MBI, HTN | HTY, GAT | Different | | Regulation Number | 21 CFR 888.3030 | 21 CFR 888.3040 | Different | | Regulation Number | 21 CFR 888.3040 | 21 CFR 878.5000 | | | Regulatory Class | Class II | Class II | Identical as predicate device. | | Intended Use | The device is intended to be used for fixation of bone to 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, | The Arthrex PCL TightRope is intended to be used for fixation of bone to 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 | Identical as predicate device. | | | ACL/PCL repair and reconstruction. | repair. For example, ACL/PCL repair and reconstruction. | | | Composition | Button compatible Loop | Button compatible Loop | Identical as predicate device. | | Key Patient Contacting Material | Button: Ti-6Al-4V ELI titanium alloy Loop: UHMWPE | Button: Ti-6Al-4V ELI titanium alloy Loop: UHMWPE | Identical as predicate device. | | Button Type | Standard button with two symmetric slots; Round button with two symmetric slots; Oblong button with two slots. | Standard button with two symmetric slots; Round button with two symmetric slots; Oblong button with two slots. | Identical as predicate device. | | Dimensional Verification | Standard button: 8 mm × 11 mm, Round button: Φ14mm, Oblong button: 3.4 mm × 13 mm Loop length: adjustable, 170mm | Standard button: 8 mm × 12 mm, Round button: Φ14mm, Oblong button: 3.4 mm × 13 mm Loop length: adjustable, 170mm | Substantially equivalent. | | 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 | The loop pass through bone tunnels and allows attachment of the button against the bone cortex. | The loop pass through bone tunnels and allows attachment of the button against the bone cortex. | Identical as predicate device. | | Environment of Use | Hospitals/clinics | Hospitals/clinics | Identical as predicate device | | Characteristics | Subject Device (Megaloop AD Device) | Predicate Device K112990, ACL TightRope RT implant | Remarks | | Product Code | MBI, HTN | HTY, GAT | Different | | Regulation Number | 21 CFR 888.3030 21 CFR 888.3040 | 21 CFR 888.3040 21 CFR 878.5000 | Different | | Regulatory Class | Class II | Class II | Identical as predicate device. | | Intended Use | The device is intended to be used for fixation of bone to 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. | The ACL TightRope and ACL TightRope Double Bundle are to be used for fixation of bone to bone or soft tissue to bone, and are intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering these for ACL/PCL repair and reconstruction. | Identical as predicate device. | | Composition | Implantable part: Button, loop Non-implantable part: Sutures | Implantable part: Button, loop Non-implantable part: Sutures | Identical as predicate device. | | Key Patient Contacting Material | Button: Ti-6Al-4V ELI titanium alloy Loop: UHMWPE | Button: Ti-6Al-4V ELI titanium alloy Loop: UHMWPE | Identical as predicate device. | | Button Type | The button is provided with two round holes and one drop type hole | The button is provided with two round holes and one drop type hole | Identical as predicate device. | | Dimensional Verification | Button: $3.4mm\times13mm$ Loop length: adjustable, after pretensioning the loop length is 600mm | Button: $3.4mm\times13mm$ Loop length: adjustable, after pretensioning the loop length is 540mm | Substantially equivalent. | | Sterilization | EO sterilization | EO sterilization | Identical as | | | | | | | Shelf-life | 5 Years | 5 Years | Identical as predicate device. | | Single Use/Reuse | Single Use | Single Use | Identical as predicate device. | | Operating Principle | The loop pass through bone 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. | The loop pass through bone 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. | | Environment of Use | Hospitals/clinics | Hospitals/clinics | Identical as predicate 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 Device (Megaloop FLB Device, Megaloop FLW Device, Megaloop XL Button) | Predicate Device | Remarks | | |------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|------------| | | | K130814, RIGIDLOOP™ Fixed Loop (primary predicate) | | | | | | K980155, EndoButton CL Ultra K190774, RIGIDLOOP™ XL Button (additional predicate) | | | | Product Code | MBI | MBI (K130814) GAT, MBI (K980155) MBI (K190774) | Identical as predicate device. | | | Regulation Number | 21 CFR 888.3040 | 21 CFR 888.3040 (K130814) 21 CFR 888.3040 21 CFR 878.5000 | Identical as predicate device. | | | | | (K980155) 21 CFR 888.3040 (K190774) | Page 8 of | | | Regulatory Class | Class II | Class II | Identical as predicate device. | | | Intended Use | 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. | The RIGIDLOOPTM Cortical Fixation System (K130814) is used for the fixation of soft tissue to bone in orthopedic procedures such as ACL repair. The EndoButton Continuous Loop (K980155) is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction. When used in conjunction with the RIGIDLOOP Cortical Fixation System, the RIGIDLOOP Cortical Fixation System XL Implant (K190774) is intended for fixation of soft tissue to bone in orthopedic procedures such as ACL repairs. | Identical as predicate device. | | | Composition | Megaloop FLB Device, Megaloop FLW Device Implantable part: Button, Loop | (K130814, K980155) Implantable part: Button, loop Non-implantable part: | Identical as predicate device. | | | | Non-implantable part: Sutures | | Sutures | | | | Megaloop XL Button Implantable part: Button | (K190774) Implantable part: Button | | | | Key Patient Contacting Material | Button: Ti-6Al-4V ELI titanium alloy Loop: UHMWPE | K130814 Button: Ti-6Al-4V ELI titanium alloy Loop: UHMWPE K980155 Button: Ti-6Al-4V ELI titanium alloy Loop: Polyethylene Terephthalate (PET) K190774 Button: Ti-6Al-4V ELI titanium alloy | Substantially equivalent. | | | Button Type | Megaloop FLB Device, Megaloop FLW Device The button is provided with four round holes Megaloop XL Button The button consists of an elongated titanium plate with a recess and two symmetrical lateral slots | (K130814, K980155) The button is provided with four round holes (K190774) The button consists of an elongated titanium plate with a recess and two symmetrical lateral slots | Identical as predicate device. | | | Loop Type | Megaloop FLW Device: weaved loop Megaloop FLB Device: blended loop | K130814: weaved loop K980155: blended loop | Identical as predicate device. | | | Dimensional Verification | Megaloop FLB Device, Megaloop FLW Device Button: 4mm × 12mm Loop length: 15-60mm in 5mm increments | K130814 Button: 4mm × 12mm Loop length: 15-60mm in 5mm increments K980155 Button width: from 4 to | Substantially equivalent. | | | | | | | Page 10 of | | | | 6mm Button length: from 12 to 18mm Loop length: 10-80 mm | | | | | Megaloop XL Button Button: 5.5mm × 20mm | K190774 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 | Megaloop FLB Device, Megaloop FLW Device 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. | (K130814, K980155) 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. | | | | Megaloop XL Button 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. | (K190774) 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 Device (Megaloop DB Device) | Predicate Device | Remarks | | | | | K043248, Knotless TightRope™ Syndesmosis Repair Kit | | | | Product Code | HTN…