(30 days)
No
The summary describes a system of plates, screws, and surgical instruments for bone stabilization, with no mention of AI or ML technology.
No
The device is described as a system of plates and screws intended for stabilization of fractures and osteotomies, which falls under surgical implantation for mechanical support, not therapy.
No
The device description clearly states it is a "system of plates and screws and surgical instruments intended for stabilization of calcaneal fractures and osteotomies," which are treatment tools, not diagnostic ones.
No
The device description explicitly states it is a system of plates, screws, and surgical instruments, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the stabilization of fractures, revision procedures, osteotomies, and reconstruction of small bones in the foot and ankle. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of plates, screws, and surgical instruments. These are physical implants and tools used during surgery.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) outside of the body to diagnose a condition or provide information about a patient's health status.
IVD devices are specifically designed to be used in vitro (outside the body) for diagnostic purposes. This device is clearly intended for in vivo (inside the body) surgical intervention.
N/A
Intended Use / Indications for Use
The In2Bones USA LLC, CoLink® Cfx System is indicated for stabilization of fractures, revision procedures, osteotomies and reconstruction of the small bones in the foot and ankle including the calcaneus in both pediatric and adult patients.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The In2Bones CoLink® Cfx Plating System is a system of plates and screws and surgical instruments intended for stabilization of calcaneal fractures and osteotomies. These subject devices are part of the overarching CoLink® Plating System and will be commonly referred to as the CoLink® Cfx Plating System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot and ankle including the calcaneus
Indicated Patient Age Range
pediatric 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® Cfx Plating System. The 3.5mm and 4.0mm screws are identical to previously cleared screws and no new worst-case plates were added. Engineering analysis was conducted related to the CoLink® Plating four-point bend testing performed per ASTM F382 to show the subject plates are substantially equivalent to the predicate plates. The CoLink® Cfx 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the date April 23, 2020. The text is written in a simple, sans-serif font. The date is written in the standard US format, with the month first, followed by the day and year. The text is black and the background is white.
In2Bones USA, LLC Christine Scifert VP of Quality and Regulatory 6000 Poplar Ave. Suite 115 Memphis, Tennessee 38119
Re: K200762
Trade/Device Name: CoLink Cfx 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: March 23, 2020 Received: March 24, 2020
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.
1
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 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
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K200762
Device Name CoLink® Cfx Plating System
Indications for Use (Describe)
The In2Bones USA LLC, CoLink® Cfx System is indicated for stabilization of fractures, revision procedures, osteotomies and reconstruction of the small bones in the foot and ankle including the calcaneus in both pediatric 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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510(k) Summary
CoLink® Cfx Plating System April 10, 2020
| Company: | In2Bones USA, LLC
6000 Poplar Ave, Suite 115
Memphis, TN 38119
901-260-7931 |
|--------------------|-------------------------------------------------------------------------------------------|
| Primary Contact: | Christine Scifert |
| Company Contact: | Rebecca Wahl |
| Trade Name: | CoLink® Cfx 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 |
| Panel: | 87-Orthopedic |
| Product Code(s): | HRS, HWC |
The In2Bones CoLink® Cfx Plating System is a system of plates and screws and Device Description: surgical instruments intended for stabilization of calcaneal fractures and osteotomies. These subject devices are part of the overarching CoLink® Plating System and will be commonly referred to as the CoLink® Cfx Plating System.
Indications for Use: The In2Bones USA LLC, CoLink® Cfx System is indicated for stabilization and fixation of fractures, revision procedures, osteotomies and reconstruction of the small bones in the foot and ankle including the calcaneus 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 In2Bones CoLink® Plating System .
Additional Predicates -
K182148 – Paragon 28 Silverback Gorilla Plating System
-
K181113 In2Bones CoLink® Afx Plating System ●
Similar to the primary predicate device (K163293), the subject CoLink® Cfx Plating System is made of Titanium Alloy and provided sterile. The CoLink® Cfx Plating System has similar indications to the CoLink® Plating System (K163293) and Silverback Gorilla Plating System (K182148). This submission is adding additional plates for the calcaneus that will be used with previously cleared screws. The 3.5mm and 4.0mm screws initially cleared in the CoLink® Afx Plating System (K181113) can be used with the CoLink® Cfx Plating System. The previously cleared CoLag® screws (K170518 and K180377) that are intended to be used as stand-alone screws can also be used during the procedure with the CoLink® Cfx Plating System, but would not be used in conjunction with the plates or screws. The subject plates and screws 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® Cfx Plating System. The 3.5mm and 4.0mm screws are identical to previously cleared screws and no new worst-case plates were added. Engineering analysis was conducted related to the CoLink® Plating four-point bend testing performed per ASTM F382 to show the subject plates are substantially equivalent to the predicate plates. The CoLink® Cfx 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.