CoLink NeoFuse Plating System

{0}------------------------------------------------ December 13, 2021 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. In2Bones USA, LLC Christine Scifert VP of Quality and Regulatory 6000 Poplar Ave, Suite 115 Memphis, Tennessee 38119 Re: K213069 Trade/Device Name: CoLink® NeoFuse Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS. HWC Dated: September 21, 2021 Received: September 23, 2021 Dear Christine Scifert: 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 {1}------------------------------------------------ statutes and regulations administered by other Federal agencies. 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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, Shumaya Ali, MPH 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}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K213069 Device Name CoLink® NeoFuse Plating System Indications for Use (Describe) The CoLink® NeoFuse Plating System is indicated for anterior fixation of ankle arthrodesis and fractures, including the distal tibia and talus. The addition of a compression screw through the tibiotalar joint (example CoLag 6.7mm screw) is required. | Type of Use (Select one or both, as applicable) | <p>☑ Residential Use (Part 21 CFR 601 Subpart E) </p> <p>☐ Compassionate Use (21 CFR 601 Subpart E)</p> | |-------------------------------------------------|---------------------------------------------------------------------------------------------------------| |-------------------------------------------------|---------------------------------------------------------------------------------------------------------| 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. 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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}------------------------------------------------ ### 510(k) Summary # CoLink® NeoFuse Plating System December 8, 2021 | Company: | In2Bones USA, LLC<br>6000 Poplar Ave, Suite 115<br>Memphis, TN 38119<br>901-260-7931 | |--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Primary Contact: | Christine Scifert | | Trade Name: | CoLink® NeoFuse Plating System | | Common Name: | Plate, Fixation, Bone<br>Screw, Fixation, Bone | | Classification: | II | | Regulation Number: | 888.3030 - Single/multiple component metallic bone fixation appliances<br>and accessories (Primary)<br>888.3040 - Smooth or threaded metallic bone fixation fastener | | Panel: | 87-Orthopedic | | Product Code(s): | HRS, HWC | Device Description: The In2Bones CoLink® NeoFuse Plating System includes sterile fusion plates and screws for anterior fixation of ankle arthrodesis and fractures, including the distal tibia and talus. The addition of a medial-lateral compression screw through the tibiotalar joint is required. These subject devices are part of the overarching CoLink® Plating System and will be commonly referred to as the CoLink NeoFuse Plating System. ### Indications for Use: The CoLink® NeoFuse Plating System is indicated for anterior fixation of ankle arthrodesis and fractures, including the distal tibia and talus. The addition of a compression screw through the tibiotalar joint (example CoLag 6.7mm screw) is required for ankle fusion procedure. {4}------------------------------------------------ Substantial Equivalence: The subject components were demonstrated to be substantially equivalent to the following systems previously cleared by the FDA: Primary Predicate - . K173121 – In2Bones SAS NeoFuse Ankle Fusion Plating System Additional Predicates - K163293 In2Bones CoLink® Plating System ● - K121425 Wright Ortholoc® 3Di Ankle Fusion Plating System ● - . K181113 – In2Bones CoLink® Afx Plating System Reference Devices - . K170518 - In2Bones Fracture and Correction System - K193543 In2Bones CoLink / Fracture and Correction System Packaging ● A comparison of the technological similarities and differences between the subject and predicate devices is shown below: | Device | CoLink® NeoFuse Plating System<br>(Subject Device) | CoLink® Plating System<br>(K163293) | In2Bones SAS NeoFuse Ankle<br>Fusion Plating System<br>(K173121) | |----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Fixation Plates and Screws | Fixation Plates and Screws | Fixation Plates and Screws | | Indications for<br>Use | The CoLink® NeoFuse Plating<br>System is a fusion plate indicated<br>for anterior fixation of ankle<br>arthrodesis and fractures,<br>including the distal tibia and<br>talus.<br>The addition of a compression<br>screw through the tibiotalar joint<br>(example CoLag 6.7mm screw) is<br>required for ankle fusion<br>procedure. | The In2Bones USA LLC, CoLink®<br>Plating System is indicated for<br>stabilization and fixation of<br>fractures, revision procedures,<br>joint fusion, osteotomies and<br>reconstruction of the small<br>bones in the hand, wrist, foot<br>and ankle in both pediatric and<br>adult patients. | The In2Bones NeoFuse Ankle<br>Fusion plating system is<br>indicated for anterior fixation of<br>ankle arthrodesis and fractures,<br>including the distal tibia, talus<br>and calcaneus.<br>The addition of a compression<br>screw through the tibiotalar<br>joint (example IBS 6.5mm<br>screw) is required. | | Product Code | HRS, HWC | HRS, HWC | HRS, HWC | | Material | Titanium Alloy (ASTM F136) | Titanium Alloy (ASTM F136) | Titanium Alloy (ASTM F136) | | Geometry and<br>Dimensions | Available in 2 styles, 2 sizes each:<br>Anterior and Anterolateral, 3<br>Hole and 5 Hole. | Plate type: MTP, Lapidus, Y-<br>Plate, Universal Plate, H-Plate;<br>2-hole through 8-hole plates | Plate: Available in 1 size only<br>Screws: | | | Screws:<br>3.5mm locking, non-locking or<br>VAL screw or 4.5mm locking,<br>non-locking or VAL screw | Screws:<br>3.0 and 3.5 locking and non-<br>locking screws | 3.5mm locking screw with<br>washer, 4.5mm locking screw<br>with washer or 4.5mm cortical<br>screw | | | Plate Length:3.10in- 4.28in<br>Plate Thickness: .098in -.123in | Plate Length: 0.9in - 2.3in<br>Plate Thickness: 0.050-.064in | Plate Length: 3.7in<br>Plate Thickness: .138in | The subject CoLink® NeoFuse Plating System is made of Titanium Alloy and has been demonstrated to be substantially equivalent to the previously cleared devices identified above as the products are similar in indications, materials and geometry. {5}------------------------------------------------ Performance Testing: Testing was conducted per a modified ASTM F382 set up for the plates for the CoLink® NeoFuse Plating System and the plates were found to be substantially equivalent. No additional mechanical testing was required for the screws. The CoLink® NeoFuse Plating System were validated per ISO 10993-1 for biocompatibility, ISO 11137-2 for gamma sterilization and ISO 11607-1 for packaging. Endotoxin testing was completed per ANSI/AAMI ST72. ### Conclusion Based on the test results and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices.