(77 days)
Not Found
No
The summary describes a system of plates, screws, and surgical instruments for fracture fixation and reconstruction, with no mention of AI or ML capabilities.
Yes
The device is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies, and reconstruction of small bones, which are therapeutic interventions.
No
Explanation: This device is a plating system used for stabilization and fixation of fractures and reconstruction. It is an orthopedic implant and does not perform diagnostic functions such as identifying or analyzing a medical condition.
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 clearly describes the device as being used for the stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies, and reconstruction of bones in the hand, wrist, foot, and ankle. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a system of plates, screws, and surgical instruments. These are physical implants and tools used during surgery.
- Lack of IVD Characteristics: An In Vitro Diagnostic device is used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with bodily specimens in this manner.
Therefore, the CoLink® Plating System is a surgical implant and instrument system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CoLink® 2 Plating System -
The In2Bones USA, CoLink® Plating System/CoLink® View Plating System/CoLink ® Mini Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.
CoLink® Afx Plating System -
The In2Bones USA, CoLink® Afx Plating System is indicated for stabilization of fractures and osteotomies in the ankle, including tibia and fibula, in both pediatric and adult patients.
The In2Bones USA CoLink® Afx Plating System screws are intended to be used as stand-alone bone screws, or in a plate-screw system for fracture fixation.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC, HTN
Device Description
The In2Bones CoLink® 2 Plating System is a system of plates and screws and surgical instruments used to treat fractures and reconstruction of the extremities. These subject devices are part of the overarching CoLink® Plating System and will be commonly referred to as the CoLink® 2 Plating System. In addition, a washer is being added to the CoLink® Afx Plating System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones in the hand, wrist, foot and ankle
ankle, including tibia and fibula
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® 2 Plating System. The 3.0mm screws are nearly identical to previously cleared screws and no new worst-case plates or screws were added. A rationale was conducted related to the CoLink® Plating four-point bend testing per ASTM F382 to show the subject plates are substantially equivalent to the predicate plates. A rationale was conducted related to the plate screws of the predicate CoLink® system for axial pullout, torque capacity and insertion torque characteristics per ASTM F543. The CoLink® 2 Plating System components and CoLink® Afx washers are not considered a worst case for sterilization, biocompatibility, shelf life and pyrogenicity and were adopted into the previous validations for the CoLink® Afx System (K181113). An assessment was conducted regarding MR environment and labeling, including RF induced heating simulation, and it was determined that the CoLink® 2 components are not considered a worst case compared to K163293. 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.
K163293, K172300, K181113, K170518, K200762
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.
Not Found
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
July 15, 2020
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 and 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 of Quality and Regulatory 6000 Poplar Ave, Suite 115 Memphis, Tennessee 38119
Re: K201149
Trade/Device Name: CoLink 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. HTN Dated: July 2, 2020 Received: July 6, 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.
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, 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K201149
Device Name CoLink® Plating System
Indications for Use (Describe)
CoLink® 2 Plating System -
The In2Bones USA, CoLink® Plating System/CoLink® View Plating System/CoLink ® Mini Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.
CoLink® Afx Plating System -
The In2Bones USA, CoLink® Afx Plating System is indicated for stabilization of fractures and osteotomies in the ankle, including tibia and fibula, in both pediatric and adult patients.
The In2Bones USA CoLink® Afx Plating System screws are intended to be used as stand-alone bone screws, or in a plate-screw system for fracture fixation.
| Type of Use (Select one or both, as applicable) |
|---|
| X 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® Plating System July 2, 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® Plating System |
| Common Name: | Plate, Fixation, Bone
Screw, Fixation, Bone
Washer, Bolt Nut |
| 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, HTN |
Device Description: The In2Bones CoLink® 2 Plating System is a system of plates and screws and surgical instruments used to treat fractures and reconstruction of the extremities. These subject devices are part of the overarching CoLink® Plating System and will be commonly referred to as the CoLink® 2 Plating System. In addition, a washer is being added to the CoLink® Afx Plating System.
Indications for Use:
CoLink® 2 Plating System
The In2Bones USA, CoLink® Plating System/CoLink® View Plating System/CoLink ® Mini Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.
4
CoLink® Afx Plating System
The In2Bones USA, CoLink® Afx Plating System is indication and fixation of fractures and osteotomies in the ankle, including tibia and fibula, in both pediatric and adult patients.
The In2Bones USA CoLink® Afx Plating System screws are intended to be used as stand-alone bone screws, or in a plate-screw system for fracture fixation.
Substantial Equivalence: The subject components were demonstrated to be substantially equivalent to the following systems previously cleared by the FDA:
Primary Predicate
-
K163293 In2Bones CoLink® Plating System .
Additional Predicates -
K172300 In2Bones CoLink® View Plating System .
-
K181113 In2Bones CoLink® Afx Plating System ●
-
K170518 In2Bones Fracture and Correction System ●
-
K200762 - In2Bones CoLink® Cfx Plating System
The subject CoLink® 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.
Performance Testing: No additional mechanical testing was required for the CoLink® 2 Plating System. The 3.0mm screws are nearly identical to previously cleared screws and no new worst-case plates or screws were added. A rationale was conducted related to the CoLink® Plating four-point bend testing per ASTM F382 to show the subject plates are substantially equivalent to the predicate plates. A rationale was conducted related to the plate screws of the predicate CoLink® system for axial pullout, torque capacity and insertion torque characteristics per ASTM F543. The CoLink® 2 Plating System components and CoLink® Afx washers are not considered a worst case for sterilization, biocompatibility, shelf life and pyrogenicity and were adopted into the previous validations for the CoLink® Afx System (K181113). An assessment was conducted regarding MR environment and labeling, including RF induced heating simulation, and it was determined that the CoLink® 2 components are not considered a worst case compared to K163293. 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.