(49 days)
Not Found
No
The summary describes a system of plates, screws, and surgical instruments for fracture fixation, with performance studies focused on mechanical properties. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is indicated for "stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction," which are therapeutic interventions.
No
The device is described as a plating system for stabilization and fixation of fractures and osteotomies, which is a treatment rather than a diagnostic function.
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 states the device is for the stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies, and reconstruction of bones. These are all surgical procedures performed 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 in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze biological samples. This device is used inside the body for structural support and fixation.
N/A
Intended Use / Indications for Use
The In2Bones USA LLC, CoLink™ 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.
The In2Bones USA LLC, CoLink™ Afx Plating System is indicated for stabilization and fixation of fractures and osteotomies in the ankle, including tibia and fibula, in both pediatric and adult patients.
Product codes
HRS, HWC
Device Description
The In2Bones CoLink™ Afx Plating System is a system of plates and screws and surgical instruments used to treat traumatic fractures and osteotomies of the ankle. These subject devices are part of the overarching CoLink™ Plating System and will be commonly referred to as the CoLink™ Afx Plating System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand, wrist, foot and ankle, ankle, 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)
Performance Testing: Static and fatigue four-point bend testing was performed per ASTM F382 on the subject CoLink™ Afx Plates and the results show the subject plates to be substantially equivalent to the predicate plates. Torsional strength, including insertion/removal torque, and axial pullout testing was performed per ASTM F543 on the subject CoLink™ Afx Screws and the results show the subject screws to be substantially equivalent to the predicate screws. Bacterial endotoxin testing (LAL) was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K163293, K172300, K983495, K151886, K011335
Reference Device(s)
Not Found
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.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 15, 2018
In2Bones USA, LLC % Christine Scifert Exec VP Mrc-x, LLC 6075 Poplar Avenue, Suite 500 Memphis, Tennessee 38119
Re: K181113
Trade/Device Name: CoLink™ Afx 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: April 26, 2018 Received: April 27, 2018
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181113
Device Name
CoLink™ Afx Plating System
Indications for Use (Describe)
The In2Bones USA LLC, CoLink™ 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.
The In2Bones USA LLC, 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.
| 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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K181113
510(k) Summary
CoLink™ Afx Plating System June 15, 2018
| Company: | In2Bones USA, LLC
6060 Poplar Ave, Suite 380
Memphis, TN 38119
901-260-7931 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Christine Scifert |
| Company Contact: | Rebecca Wahl |
| Trade Name: | CoLink™ Afx 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 In2Bones CoLink™ Afx Plating System is a system of plates and screws and Device Description: surgical instruments used to treat traumatic fractures and osteotomies of the ankle. These subject devices are part of the overarching CoLink™ Plating System and will be commonly referred to as the CoLink™ Afx Plating System.
The In2Bones USA LLC, CoLink™ Plating System is indicated for stabilization Indications for Use: 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.
The In2Bones USA LLC, CoLink™ Afx Plating System is indicated for stabilization and fixation of fractures and osteotomies in the ankle, including tibia and fibula, in both pediatric and adult patients.
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K181113
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™ Plating System
-
K983495- Syntec-Taichung Plates ●
-
. K151886- Acumed Ankle Fracture System Gen III
-
K011335 Synthes One-Third Tubular DCL Plate ●
The subject CoLink™ Plating System made of Titanium Alloy and Commercially Pure Titanium and 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: Static and fatigue four-point bend testing was performed per ASTM F382 on the subject CoLink™ Afx Plates and the results show the subject plates to be substantially equivalent to the predicate plates. Torsional strength, including insertion/removal torque, and axial pullout testing was performed per ASTM F543 on the subject CoLink™ Afx Screws and the results show the subject screws to be substantially equivalent to the predicate screws. Bacterial endotoxin testing (LAL) was performed.
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.