(164 days)
No
The summary describes a system of plates, screws, and surgical instruments for bone fixation, with no mention of AI, ML, image processing, or any software-driven analytical capabilities.
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 (plates, screws, and surgical instruments) used for stabilization and fixation of fractures and reconstruction of small bones, indicating a therapeutic or surgical purpose, not a diagnostic one.
No
The device description explicitly states it is a "system of plates and screws and surgical instruments," which are physical hardware components. The performance studies also describe testing on these physical 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 that the system is for the "stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle". This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a "system of plates and 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 (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health. IVDs are typically used for diagnosis, monitoring, or screening based on laboratory tests.
Therefore, the In2Bones USA LLC, CoLink™ Plating System is a surgical device used for orthopedic procedures, not an in vitro diagnostic device.
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.
Product codes
HRS, HWC
Device Description
The In2Bones CoLink™ Plating System is a system of plates and screws and surgical instruments used to treat fracture and reconstruction of the bones of the extremities.
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
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
Testing including bacterial endotoxin, static driving torque, static pullout, static torsion, screw/plate push through, static bending and pullout fixation were performed. The results of the testing demonstrate that the device is substantially equivalent to the predicate device identified.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 5, 2017
In2Bones USA, LLC % Louise Focht President Enmed International, Inc PO Box 249 Del Mar, California 92014
Re: K163293 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 Dated: April 1, 2017 Received: April 4, 2017
Dear Ms. Focht:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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) K163293
Device Name
CoLink™ 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.
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 of Safety and Effectiveness K163293
Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:
- I. Submitter
| Date Prepared: | May 4, 2017 |
|---|---|
| Device Submitter: | In2Bones USA, LLC |
| 6060 Poplar Avenue, Suite 380 | |
| Memphis, TN 38119 | |
| Phone: | 901-260-7931 |
| Contact Person: | Louise Focht |
II. Device
| Proprietary Name: | Colink™ Plating System |
|---|---|
| Common Name: | Plate, Fixation, Bone |
| Screw, Fixation, Bone | |
| Classification Name: | Single/multiple component metallic bone fixation |
| appliances and accessories | |
| Smooth or threaded metallic bone fixation fastener. | |
| Regulatory Class: | 21 CFR 888.3030, Class II |
| 21 CFR 888.3040, Class II | |
| Product Code: | 87 HRS, HWC |
III. Predicate Device
| Predicate Device: | Stryker (Memometal) Anchorage Bone Plate System,
K083447
Integra Total Foot System, K123000 |
|-------------------|----------------------------------------------------------------------------------------------------------------------------|
| Reference Device: | In2Bones SAS, I.B.S. Osteosynthesis screws, K131920
In2Bones USA, RTS System, K153609
In2Bones USA, NeoSpan, K161426 |
IV. Device DescriptionThe In2Bones CoLink™ Plating System is a system of plates and screws and surgical instruments used to treat fracture and reconstruction of the bones of the extremities.
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V. Intended Use and 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. -
VI. Comparison of technological characteristics with the predicate device
The In2Bones USA CoLink™ Plating System and the legally marketed predicate device have the same intended use and similar indications for use, similar dimensions, geometry and materials. The In2Bones device and the predicate are both available in multiple sizes and various shapes. The plates are attached to bone using various diameter and length screws. The In2Bones USA CoLinkTM System is made from titanium alloy.
VII. Performance Data
Testing including bacterial endotoxin, static driving torque, static pullout, static torsion, screw/plate push through, static bending and pullout fixation were performed. The results of the testing demonstrate that the device is substantially equivalent to the predicate device identified.
VIII. Conclusions
The In2Bones USA CoLink™ Plating System when compared to the predicate have similar intended use and indications for use, technological characteristics, and principals of operation as the predicate device. Thus, the In2Bones USA Colink™ Plating System design characteristics do not raise any new types of questions of safety or effectiveness and thus is substantially equivalent to the predicate device.