K Number
K210060
Device Name
CoLink Mfx Implant System
Manufacturer
Date Cleared
2021-03-12

(60 days)

Product Code
Regulation Number
888.3030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CoLink® Mfx Plating System is intended for stabilization of fractures, revision procedures, joint fusion, osteotomies and reconstruction in the midfoot bones of the foot, including repair of Lis Franc injuries, in both pediativ and adult patients.
Device Description
The CoLink® Mfx Plating System is a line extension to the current CoLink® plating system offerings. The CoLink® Mfx Plating System has eight plate styles: 1st TMT Plates, 1st/2nd Lisfranc Plates, 2nd/3rd Lisfranc Plates, an NC Plate, a Medial Column TNC Plate, a Medial Column NCM Plate, and a Medial Column Bridge Plate. The plates and associated screws are manufactured from Titanium Alloy (ASTM F136).
More Information

No
The 510(k) summary describes a mechanical plating system for bone fixation and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.

No.

Explanation: This device is an orthopedic plating system used for the stabilization of fractures and reconstruction in the midfoot bones, which is a structural support function rather than a therapeutic treatment in the sense of actively treating a disease or condition with a curative or palliative effect.

No
Explanation: This device is a plating system intended for the surgical stabilization of foot fractures and other orthopedic conditions. It does not perform any diagnostic functions like analyzing data or generating diagnostic information.

No

The device description explicitly states that the system includes plates and screws manufactured from Titanium Alloy, which are hardware components.

Based on the provided information, the CoLink® Mfx Plating System is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • Intended Use: The intended use is for the stabilization of fractures, revision procedures, joint fusion, osteotomies, and reconstruction in the midfoot bones of the foot. This is a surgical procedure performed directly on the patient's body.
  • Device Description: The device consists of plates and screws made of titanium alloy, which are implanted into the body.
  • Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The CoLink® Mfx Plating System does not perform this function.

Therefore, the CoLink® Mfx Plating System is a surgical implant device, not an IVD.

N/A

Intended Use / Indications for Use

The CoLink® Mfx Plating System is intended for stabilization of fractures, revision procedures, joint fusion, osteotomies and reconstruction in the midfoot bones of the foot, including repair of Lis Franc injuries, in both pediativ and adult patients.

Product codes

HRS, HWC

Device Description

The CoLink® Mfx Plating System is a line extension to the current CoLink® plating system offerings. The CoLink® Mfx Plating System has eight plate styles: 1st TMT Plates, 1st/2nd Lisfranc Plates, 2nd/3rd Lisfranc Plates, an NC Plate, a Medial Column TNC Plate, a Medial Column NCM Plate, and a Medial Column Bridge Plate. The plates and associated screws are manufactured from Titanium Alloy (ASTM F136).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

midfoot bones of the foot

Indicated Patient Age Range

pediativ and adult patients

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

No additional mechanical testing was required for the CoLink® Mfx Plating System. The 3.0mm, 3.5mm and 4.0mm screws are identical to previously cleared screws and no new worst-case plates were added. Engineering analysis was conducted to the CoLink® Plating fourpoint bend testing performed per ASTM F382 to show the subject plates are substantially equivalent to the predicate plates. The CoLink® Mfx Plating System is not a worst case for sterilization, biocompatibility, shelf life and pyrogenicity and was adopted into the previous validations for the CoLink® Afx System (K181113). Bacterial endotoxin testing (LAL) is performed on each lot.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K163293, K181113, K152974

Reference Device(s)

K201149, K180377

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

March 12, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

In2Bones USA, LLC Christine Scifert VP, QA & RA 6000 Poplar Ave. Suite 115 Memphis, Tennessee 38119

Re: K210060

Trade/Device Name: CoLink Mfx Implant 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: January 7, 2021 Received: January 11, 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 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

1

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 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).

Sincerely,

For: Shumaya Ali, M.P.H. 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) K210060

Device Name CoLink® Mfx Plating System

Indications for Use (Describe)

The CoLink® Mfx Plating System is intended for stabilization of fractures, revision procedures, joint fusion, osteotomies and reconstruction in the midfoot bones of the foot, including repair of Lis Franc injuries, in both pediativ and adult patients.

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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3

510(k) Summary

CoLink® Mfx Plating System March 12, 2021

| Company: | In2Bones USA, LLC
6000 Poplar Ave, Suite 115
Memphis, TN 38119
901-260-7931 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Christine Scifert |
| Trade Name: | CoLink® Mfx Plating System |
| Common Name: | Plate, Fixation, Bone
Screw, Fixation, Bone |
| Classification: | II |
| Regulation Number: | 888.3030 - Single/multiple component metallic bone fixation appliances
and accessories
888.3040 - Smooth or threaded metallic bone fixation fastener |
| Panel: | 87-Orthopedic |
| Product Code(s): | HRS, HWC |

The CoLink® Mfx Plating System is a line extension to the current CoLink® Device Description: plating system offerings. The CoLink® Mfx Plating System has eight plate styles: 1st TMT Plates, 1st/2nd Lisfranc Plates, 2nd/3rd Lisfranc Plates, an NC Plate, a Medial Column TNC Plate, a Medial Column NCM Plate, and a Medial Column Bridge Plate. The plates and associated screws are manufactured from Titanium Alloy (ASTM F136).

Indications for Use: The CoLink® Mfx Plating System is intended for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction in the midfoot bones of the foot, including repair of Lis Franc injuries, in both pediatric and adult patients.

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

4

Primary Predicate

  • K163293 CoLink® Plating System .
    Additional Predicates

  • . K181113 – CoLink® Afx Plating System

  • K152974 Wright Ortholoc® 3Di Foot Plating Reconstruction System ●

Reference Device

  • K201149 CoLink® Plating System .
  • K180377 Fracture and Correction System ●

Similar to the primary predicate device (K163293), the subject CoLink® Mfx Plating System is made of Titanium Alloy and provided sterile. The CoLink® Mfx Plating System has similar indications to the CoLink® Plating System (K163293) and Wright Ortholoc® 3Di Foot Plating Reconstruction System (K152974). This submission is adding additional plates for the midfoot that will be used with previously cleared screws. The previously cleared 3.5mm screws from the CoLink® Afx Plating System (K181113), 3.0mm screws cleared in CoLink® Plating System (K201149) and the CoLag 4.0 Compression and FT screws cleared in the Fracture and Correction System (K180377) can be used with the CoLink® Mfx Plating System. There are no additional screws being introduced that are specific to the CoLink® Mfx Plating System. The subject plates have been demonstrated to be substantially equivalent to the previously cleared devices identified above as the products are similar in indications, materials and geometry.

Performance Testing: No additional mechanical testing was required for the CoLink® Mfx Plating System. The 3.0mm, 3.5mm and 4.0mm screws are identical to previously cleared screws and no new worst-case plates were added. Engineering analysis was conducted to the CoLink® Plating fourpoint bend testing performed per ASTM F382 to show the subject plates are substantially equivalent to the predicate plates. The CoLink® Mfx Plating System is not a worst case for sterilization, biocompatibility, shelf life and pyrogenicity and was adopted into the previous validations for the CoLink® Afx System (K181113). Bacterial endotoxin testing (LAL) is performed on each lot.

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.