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.

AI/ML Overview

This is not an AI/ML device, so elements of the typical AI/ML acceptance criteria and study information are not applicable. The provided text describes a traditional medical device (metallic bone fixation system) and its regulatory clearance process, which focuses on demonstrating substantial equivalence to previously cleared predicate devices through performance testing and material comparisons.

Here's a breakdown based on the provided text, indicating where information is not applicable (N/A) for this type of device:

Device Name: CoLink® NeoFuse Plating System
510(k) Number: K213069

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What was tested)	Reported Device Performance (Study Results)
Mechanical Performance:
- Plate mechanical strength (ASTM F382)	"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." (Implies meeting or exceeding the performance of the predicate device under these testing conditions).
- Screw mechanical performance (No new testing required)	"No additional mechanical testing was required for the screws." (Indicates screws are substantially equivalent based on prior clearances or material properties).
Biocompatibility:
- Biocompatibility (ISO 10993-1)	"The CoLink® NeoFuse Plating System were validated per ISO 10993-1 for biocompatibility..."
Sterilization:
- Gamma Sterilization (ISO 11137-2)	"...ISO 11137-2 for gamma sterilization..."
Packaging:
- Packaging (ISO 11607-1)	"...and ISO 11607-1 for packaging."
Endotoxins:
- Endotoxin testing (ANSI/AAMI ST72)	"Endotoxin testing was completed per ANSI/AAMI ST72."
Material Composition:
- Material (Titanium Alloy ASTM F136)	"The subject CoLink® NeoFuse Plating System is made of Titanium Alloy..." (Matches predicate devices).
Indications for Use:
- Equivalence of Indications for Use	The Indications for Use for the CoLink® NeoFuse Plating System are considered similar to the primary predicate K173121 – In2Bones SAS NeoFuse Ankle Fusion Plating System.
Technological Characteristics (Design, Geometry):
- General design, dimensions, and screw types compared to predicates.	The device has "similarities and differences" in geometry and dimensions compared to predicates (e.g., available in 2 styles, 2 sizes each: Anterior and Anterolateral, 3 Hole and 5 Hole, Plate Length: 3.10in- 4.28in, Plate Thickness: .098in -.123in), but these were considered substantially equivalent.

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

Sample Size: The document does not specify the exact number of plates or screws tested. It refers to "testing conducted per a modified ASTM F382 set up" for plates. For biocompatibility, sterilization, packaging, and endotoxin tests, these are typically conducted on representative samples of the device and its components, but specific sample numbers are not provided.
Data Provenance: Not explicitly stated, but typically, these types of performance tests are conducted in a laboratory setting (e.g., by the manufacturer or a contract testing facility) in support of regulatory submissions. This is not clinical data, so terms like "retrospective" or "prospective" do not apply.

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)

N/A. This is a hardware device review, not an AI/ML diagnostic or prognostic device that relies on ground truth established by experts interpreting clinical data. Ground truth in this context refers to the validated performance of the physical device under various engineering tests. Expert involvement would be in the design, testing methodology, and interpretation of engineering data, rather than clinical interpretation.

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

N/A. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple experts evaluate ambiguous cases or results for AI/ML performance evaluation. This device's evaluation is based on objective engineering tests and material comparisons.

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

N/A. No MRMC comparative effectiveness study was performed as this is not an AI/ML device designed to assist human readers.

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

N/A. This is not an AI/ML algorithm. Its "performance" is assessed through physical and material testing, not through algorithmic output.

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

Engineering Standards and Predicate Device Performance: The "ground truth" for this device's acceptance is based on its ability to meet established engineering standards (e.g., ASTM F382, ISO 10993-1, ISO 11137-2, ISO 11607-1, ANSI/AAMI ST72) and demonstrate "substantial equivalence" in mechanical properties, biocompatibility, sterilization, and function to previously cleared predicate devices. The performance of predicate devices against these standards serves as a benchmark.

8. The sample size for the training set

N/A. This is not an AI/ML device, so there is no "training set."

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

N/A. As there is no training set for an AI/ML algorithm, this question is not applicable.

Summary

{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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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)	☑ Residential Use (Part 21 CFR 601 Subpart E) ☐ Compassionate Use (21 CFR 601 Subpart E)
-------------------------------------------------	---------------------------------------------------------------------------------------------------------

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

CoLink® NeoFuse Plating System December 8, 2021

Company:	In2Bones USA, LLC6000 Poplar Ave, Suite 115Memphis, TN 38119901-260-7931
Primary Contact:	Christine Scifert
Trade Name:	CoLink® NeoFuse Plating System
Common Name:	Plate, Fixation, BoneScrew, Fixation, Bone
Classification:	II
Regulation Number:	888.3030 - Single/multiple component metallic bone fixation appliancesand accessories (Primary)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(Subject Device)	CoLink® Plating System(K163293)	In2Bones SAS NeoFuse AnkleFusion Plating System(K173121)
Intended Use	Fixation Plates and Screws	Fixation Plates and Screws	Fixation Plates and Screws
Indications forUse	The CoLink® NeoFuse PlatingSystem is a fusion plate indicatedfor anterior fixation of anklearthrodesis and fractures,including the distal tibia andtalus.The addition of a compressionscrew through the tibiotalar joint(example CoLag 6.7mm screw) isrequired for ankle fusionprocedure.	The In2Bones USA LLC, CoLink®Plating System is indicated forstabilization and fixation offractures, revision procedures,joint fusion, osteotomies andreconstruction of the smallbones in the hand, wrist, footand ankle in both pediatric andadult patients.	The In2Bones NeoFuse AnkleFusion plating system isindicated for anterior fixation ofankle arthrodesis and fractures,including the distal tibia, talusand calcaneus.The addition of a compressionscrew through the tibiotalarjoint (example IBS 6.5mmscrew) 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 styles, 2 sizes each:Anterior and Anterolateral, 3Hole and 5 Hole.	Plate type: MTP, Lapidus, Y-Plate, Universal Plate, H-Plate;2-hole through 8-hole plates	Plate: Available in 1 size onlyScrews:
	Screws:3.5mm locking, non-locking orVAL screw or 4.5mm locking,non-locking or VAL screw	Screws:3.0 and 3.5 locking and non-locking screws	3.5mm locking screw withwasher, 4.5mm locking screwwith washer or 4.5mm corticalscrew
	Plate Length:3.10in- 4.28inPlate Thickness: .098in -.123in	Plate Length: 0.9in - 2.3inPlate Thickness: 0.050-.064in	Plate Length: 3.7inPlate 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.

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.