(119 days)
Not Found
No
The description focuses on the materials and mechanical properties of bone plates and screws, with no mention of AI or ML.
No
The device is described as a system of plates and screws for fracture fixation and reconstruction of small bones, which are surgical implants rather than devices designed to treat, cure, or prevent disease or provide therapy.
No
Explanation: The device is described as a plating system intended for fixation of fractures and reconstruction of small bones, which are therapeutic rather than diagnostic purposes.
No
The device description explicitly states it is a system of plates, screws, and surgical instruments made of physical materials (Titanium and PEEK), indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "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 implant used in vivo (within the body) to treat physical conditions.
- Device Description: The device is described as a "system of plates and screws and surgical instruments". These are physical components used in surgery.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The information provided clearly indicates this is a surgical implant system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The In2Bones USA LLC, CoLink™ Plating System is indication and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediativ and adult patients.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The In2Bones CoLink™ View Plating System is a system of plates and screws and surgical instruments used to treat fracture and reconstruction of the extremities. The current plate offering cleared under K163293 are made of ASTM F 136 Titanium 6Aluminum 4Vanadium Alloy (Ti6Al4V) material. The scope of this submission is to add plates that include inserts made of ASTM F 2026 Poly Ether Ether Ketone (PEEK) or ASTM F 136 Titanium 4Vanadium Alloy (Ti6A14V) materials.
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
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)
Mechanical testing four-point bend testing was performed per ASTM F382-14 on the subject CoLink™ View Plates and the results show the subject plates to be substantially equivalent to the predicate plates. Material Mediated Pyrogen Testing and bacterial endotoxin testing were conducted to establish non-pyrogenicity.
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.
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 27, 2017
In2Bones USA, LLC % Christine Scifert Exec VP MRC-X, LLC 6060 Poplar Ave, Suite 380 Memphis, Tennessee 38119
Re: K172300
Trade/Device Name: CoLink™ View 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: October 19, 2017 Received: October 20, 2017
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);
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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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)
Device Name CoLink™ Plating System
Indications for Use (Describe)
The In2Bones USA LLC, CoLink™ Plating System is indication and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediativ and adult patients.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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510(k) Summary
CoLink™ Plating System November 22, 2017
| 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: | CoLinkTM View 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™ View Plating System is a system of plates and screws and Device Description: surgical instruments used to treat fracture and reconstruction of the extremities. The current plate offering cleared under K163293 are made of ASTM F 136 Titanium 6Aluminum 4Vanadium Alloy (Ti6Al4V) material. The scope of this submission is to add plates that include inserts made of ASTM F 2026 Poly Ether Ether Ketone (PEEK) or ASTM F 136 Titanium 4Vanadium Alloy (Ti6A14V) materials.
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.
Substantial Equivalence: The subject components were demonstrated to be substantially equivalent to the following systems previously cleared by the FDA:
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Primary Predicate
-
K163293 In2Bones CoLink™ Plating System .
Additional Predicates -
K120157 Wright Medical Mini MaxLock Extreme® Plating System ●
The subject CoLink™ Plating System made of Titanium Alloy and PEEK have demonstrated to be substantially equivalent to the previously cleared devices cleared under K163293 and K120157 as the products are similar in indications, materials and geometry.
Performance Testing: Mechanical testing four-point bend testing was performed per ASTM F382-14 on the subject CoLink™ View Plates and the results show the subject plates to be substantially equivalent to the predicate plates. Material Mediated Pyrogen Testing and bacterial endotoxin testing were conducted to establish non-pyrogenicity.
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.