The CoLink® NeoFuse MIS Plating System is a fusion plate indicated for anterior fixation of ankle arthrodesis and fractures, including the distal tibia and talus. The addition of a posterior compression screw and a fully threaded screw through the tibiotalar joint (example CoLag 6.7mm screw) are required for ankle fusion procedure.

Device Description

The CoLink® NeoFuse MIS 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 a line extension of the CoLink® NeoFuse Plating System.

AI/ML Overview

The provided text describes a medical device, the "CoLink® NeoFuse MIS Plating System," which is a fusion plate used for anterior fixation of ankle arthrodesis and fractures. This document is a 510(k) Pre-market Notification from the FDA, indicating a review of the device's substantial equivalence to existing legally marketed devices.

Based on the provided text, the following information can be extracted regarding the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of numerical acceptance criteria with corresponding performance metrics like sensitivity, specificity, or AUC, as would be typical for an AI-powered diagnostic device. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices through various performance tests and comparisons.

The primary acceptance criteria for this type of medical device (a bone fixation system) revolve around:

Mechanical Performance: The device must meet sufficient mechanical strength and fatigue properties to perform its intended function.
Biocompatibility: The materials used must be safe for implantation in the human body.
Sterility: The device must be sterile and maintain its sterility.
Packaging Integrity: The packaging must protect the device and maintain sterility until use.
Dimensional and Material Equivalence: The subject device's geometry, dimensions, and materials should be comparable to predicate devices.

Table of Performance (Based on provided text):

Performance Aspect	Acceptance Criteria (Implied by Substantial Equivalence to Predicates)	Reported Device Performance
Mechanical	The mechanical performance should be comparable to or better than predicate devices for bone fixation. Demonstrated adequacy through testing simulating in vivo loading conditions. (ASTM F382, modified). The device should withstand anticipated forces without failure and maintain stability for fixation.	"Testing was conducted per a modified ASTM F382 set up for the plates for the CoLink NeoFuse MIS Plating System and the plates were found to be substantially equivalent." "The test setup was modified from ASTM F382 to more accurately simulate anticipated mechanical loading on the plate in vivo." "No additional mechanical testing was required for the screws." (This implies the screws either meet requirements via predicate comparison or prior testing, which isn't detailed for the subject device.)
Biocompatibility	The device materials must be biologically safe for human implantation. (ISO 10993-1).	"The CoLink NeoFuse MIS Plating System was validated per ISO 10993-1 for biocompatibility..."
Sterilization	The device must be terminally sterilized and maintain sterility. Its sterilization method (gamma) must be validated to achieve a specified sterility assurance level (SAL). (ISO 11137-2).	"...ISO 11137-2 for gamma sterilization..."
Packaging	The packaging must maintain product sterility and integrity until the point of use. (ISO 11607-1).	"...and ISO 11607-1 for packaging."
Endotoxins	The device must have endotoxin levels below specified limits for implantable devices. (ANSI/AAMI ST72).	"Endotoxin testing was completed per ANSI/AAMI ST72."
Material	Must use medical-grade materials suitable for implantation, comparable to predicate devices.	"Titanium Alloy (ASTM F136)" - Same as predicates.
Intended Use & Indications for Use (IFU)	The subject device's intended use and Indications for Use should be substantially equivalent to the predicate devices, allowing for minor differences that do not raise new questions of safety or effectiveness. Minimal differences from predicate IFU regarding anatomical locations and required additional screws.	Subject device: "The CoLink® NeoFuse MIS Plating System is a fusion plate indicated for anterior fixation of ankle arthrodesis and fractures, including the distal tibia, talus, and calcaneus. The addition of a posterior compression screw and a fully threaded screw through the tibiotalar joint (example CoLag 6.7mm screw) is required." Predicate K213069: "...including the distal tibia, talus, and calcaneus. The addition of a compression screw through the tibiotalar joint (example CoLag 6.7mm screw) is required." (Minor difference: subject specifies "posterior compression screw and a fully threaded screw" vs. just "compression screw").

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide numerical sample sizes for mechanical testing (e.g., number of plates tested). It states "Testing was conducted per a modified ASTM F382 set up for the plates...". For biocompatibility, sterilization, and packaging, it refers to validation according to international standards (ISO, ANSI/AAMI), which implies that appropriate sample sizes were used as dictated by those standards for validation studies, but these specific numbers are not detailed in this summary.

There is no mention of data provenance (e.g., country of origin or retrospective/prospective nature) as this is not a clinical study involving human patient data, but rather performance testing of the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. The device is a physical bone fixation system, not a diagnostic AI device requiring expert ground truth for interpretation of medical images or patient outcomes. The "ground truth" for the mechanical performance testing would be the physical properties and failure points observed during the standardized tests, compared against established engineering and regulatory benchmarks.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods are relevant for studies involving human interpretation (e.g., of medical images) where discrepancies need to be resolved. This document details engineering and performance testing, not clinical interpretation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. An MRMC study is relevant for AI-powered diagnostic devices that assist human readers. The CoLink® NeoFuse MIS Plating System is a surgical implant, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance testing is based on:

Standardized Test Methods: Adherence to and performance within established engineering standards (e.g., ASTM F382, ISO 10993-1, ISO 11137-2, ISO 11607-1, ANSI/AAMI ST72).
Predicate Device Performance: The underlying assumption of substantial equivalence is that the predicate devices are safe and effective, and thus the subject device, performing comparably, is also considered safe and effective.

8. The sample size for the training set

This is not applicable. There is no "training set" as this device is not an AI algorithm requiring machine learning.

9. How the ground truth for the training set was established

This is not applicable for the same reason as above.

Summary

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August 13, 2024

In2Bones USA Christine Scifert VP of Quality Assurance & Regulatory Affairs 6000 Poplar Ave. Suite 115 Memphis, Tennessee 38119

Re: K241387

Trade/Device Name: CoLink NeoFuse MIS 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: May 13, 2024 Received: May 15, 2024

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 (the 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.

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).

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Your device is also subject to, among other requirements. the Quality System (OS) 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 (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/combinationproducts/guidance-regulatory-information/postmarketing-safety-reporting-combination-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-devices/medical-device-safety/medical-device-reporting-mdr-how-reportmedical-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/medical-devices/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuingeducation/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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumereducation-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Christopher Ferreira -S

Christopher Ferreira, M.S. 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

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Indications for Use

510(k) Number (if known) K241387

Device Name CoLink® NeoFuse MIS Plating System

Indications for Use (Describe)

The CoLink® NeoFuse MIS Plating System is a fusion plate indicated for anterior fixation of ankle arthrodesis and fractures, including the distal tibia and talus.

The addition of a posterior compression screw and a fully threaded screw through the tibiotalar joint (example CoLag 6.7mm screw) are required for ankle fusion procedure.

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)

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K241387 510(k) Summary

CoLink® NeoFuse MIS Plating System August 12, 2024

Company:	In2Bones USA, LLC6000 Poplar Ave, Suite 115Memphis, TN 38119901-260-7931
Primary Contact:	Christine Scifert
Trade Name:	CoLink® NeoFuse MIS Plating System
Common Name:	Plate, Fixation, BoneScrew, Fixation, Bone
Classification:	II
Regulation Number:	888.3030 - Single/multiple component metallic bone fixation appliancesand accessories888.3040 - Smooth or threaded metallic bone fixation fastener
Panel:	87-Orthopedic
Product Code(s):	HRS, HWC

The CoLink® NeoFuse MIS Plating System includes sterile fusion plates and Device Description: 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 a line extension of the CoLink® NeoFuse Plating System.

Indications for Use:

The CoLink® NeoFuse MIS Plating System is a fusion plate indicated for anterior fixation of ankle arthrodesis and fractures, including the distal tibia and talus.

The addition of a posterior compression screw and a fully threaded screw through the tibiotalar joint (example CoLag 6.7mm screw) are required for ankle fusion procedure.

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Substantial Equivalence: The subject components were demonstrated to be substantially equivalent to the following systems previously cleared by the FDA:

Primary Predicate

. K213069 – In2Bones CoLink® NeoFuse Plating System
Additional Predicate
K173121 In2Bones SAS NeoFuse Ankle Fusion Plating System .
Reference Devices
K181113 In2Bones CoLink® Afx Plating System .
. K170518 – In2Bones Fracture and Correction System
. K213698 – In2Bones CoLink® PCR Plating System

A comparison of the technological similarities and differences between the subject and predicate devices is shown below.

Device	CoLink® NeoFuse MIS Plating System(Subject Device)	CoLink® NeoFuse Plating System(K213069)	In2Bones SAS NeoFuse Ankle FusionPlating System (K173121)
Intended Use	Fixation Plates and Screws	Fixation Plates and Screws	Fixation Plates and Screws
Indications for Use	The CoLink® NeoFuse MIS PlatingSystem is a fusion plate indicated foranterior fixation of ankle arthrodesisand fractures, including the distal tibia,talus, and calcaneus.	The CoLink® NeoFuse Plating System isa fusion plate indicated for anteriorfixation of ankle arthrodesis andfractures, including the distal tibia,talus, and calcaneus.	The In2Bones NeoFuse Ankle Fusionplating system is indicated for anteriorfixation of ankle arthrodesis andfractures, including the distal tibia,talus and calcaneus.
	The addition of a posterior compressionscrew and a fully threaded screwthrough the tibiotalar joint (exampleCoLag 6.7mm screw) is required.	The addition of a compression screwthrough the tibiotalar joint (exampleCoLag 6.7mm screw) is required.	The addition of a compression screwthrough the tibiotalar joint (exampleIBS 6.5mm 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 andDimensions	Available in 2 configurations:Standard and Ø3.5mm Talar HolesScrews:Talar fixation: Either 4.5mm, or 3.5mmlocking, non-locking or VAL screw; also5.0mm non-locking cancellous for thestandard plateTibial fixation: 4.5mm locking, non-locking or VAL screw or 5.0mm non-locking cancellous screw	Available in 2 styles, 2 sizes each:Anterior and Anterolateral, 3 Hole and5 Hole.Screws:Talar fixation: 3.5mm locking, non-locking or VAL screw;Tibial fixation: 4.5mm locking, non-locking or VAL screw;Transverse screw: 4.5mm non-lockingscrew.	Available in 1 size onlyScrews:Talar fixation: 3.5mm locking screwwith washer;Tibial fixation: 4.5mm locking screwwith washer;Transarticular screw: 4.5mm corticalscrew.
	Plate Length:1.87inPlate Thickness: .098in -.140inShaft width: .410in - .453inTalar width:.816in	Plate Length:3.10in- 4.28inPlate Thickness: .098in -.123inShaft width: .460in - .492inTalar width:.953-1.020in	Plate Length: 3.7in (94mm)Plate Thickness: .138in (3.5mm)Shaft width: .497in (12.54mm)Talar width: 1.020in (25.9mm)

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Performance Testing: Testing was conducted per a modified ASTM F382 set up for the plates for the CoLink NeoFuse MIS Plating System and the plates were found to be substantially equivalent. The test setup was modified from ASTM F382 to more accurately simulate anticipated mechanical loading on the plate in vivo. No additional mechanical testing was required for the screws. The CoLink NeoFuse MIS Plating System was 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.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.