(23 days)
No
The 510(k) summary describes a system of plates, screws, and surgical instruments for fracture fixation and reconstruction. The submission focuses on a change in the supplier of the PEEK material, with no mention of software, algorithms, or any AI/ML related terms or functionalities.
No
The device is described as a system of plates, screws, and surgical instruments used for the fixation and reconstruction of fractures and osteotomies. It is designed to provide structural support for healing, rather than actively treating an illness or condition.
No
The device description clearly states it is a "system of plates and screws and surgical instruments used to treat fracture and reconstruction of the extremities," indicating it is a therapeutic device, not a diagnostic one. Its intended use is for "fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction," which are all treatment procedures.
No
The device description explicitly states it is a system of plates, screws, and surgical instruments, which are physical hardware components. The submission focuses on a material change for the plates, not software.
Based on the provided text, 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 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 in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, while this device is used for surgical intervention and fixation within the body.
N/A
Intended Use / Indications for Use
The In2Bones USA LLC, CoLink® Plating System/CoLink® View Plating System is indication and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of 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.
Product codes (comma separated list FDA assigned to the subject device)
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 extremities. Previous clearances include plates made from F 136 Titanium 6Aluminum 4Vanadium Alloy (Ti6Al4V ELI) material (K163293) and plates that include inserts made of ASTM F 2026 Poly Ether Ether Ketone (PEEK) or ASTM F 136 Titanium 6Aluminum 4Vanadium Alloy (Ti6Al4V ELI) materials (K172300). The PEEK material cleared previously was from the supplier, Evonik Industries. The scope of this submission is to modify the supplier of the PEEK material from Evonik Industries to Invibio Biomaterial Solutions. There is no design change to the implants and the instruments used with the system are identical. The Invibio PEEK material meets ASTM F 2026.
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, 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)
Performance Testing: No additional mechanical testing or validations were required to establish substantial equivalence.
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 contains two logos. On the left is the logo for the Department of Health & Human Services, which features a stylized human figure. To the right is the logo for the U.S. Food & Drug Administration (FDA). The FDA logo includes the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" written below in a smaller font.
In2Bones USA, LLC Christine Scifert Senior Director of Regulatory Affairs 6060 Poplar Ave. Suite 380 Memphis. Tennessee 38119
September 27, 2018
Re: K182402
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: August 31, 2018 Received: September 4, 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. 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 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
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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,
Jesse Muir -S 2018.09.27 18:49:41 -04'00'
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K182402
Device Name CoLink(r) View Plating System
Indications for Use (Describe)
The In2Bones USA LLC, CoLink® Plating System/CoLink® View Plating System is indication and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of 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)
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)
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510(k) Summary
CoLink® View Plating System Special 510(k) September 25, 2018
| Company: | In2Bones USA, LLC
6060 Poplar Ave, Suite 380
Memphis, TN 38119
901-260-7931 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Christine Scifert |
| Trade Name: | CoLink® 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® Plating System is a system of plates and screws and Device Description: surgical instruments used to treat fracture and reconstruction of the extremities. Previous clearances include plates made from F 136 Titanium 6Aluminum 4Vanadium Alloy (Ti6Al4V ELI) material (K163293) and plates that include inserts made of ASTM F 2026 Poly Ether Ether Ketone (PEEK) or ASTM F 136 Titanium 6Aluminum 4Vanadium Alloy (Ti6Al4V ELI) materials (K172300). The PEEK material cleared previously was from the supplier, Evonik Industries. The scope of this submission is to modify the supplier of the PEEK material from Evonik Industries to Invibio Biomaterial Solutions. There is no design change to the implants and the instruments used with the system are identical. The Invibio PEEK material meets ASTM F 2026.
Indications for Use: The In2Bones USA LLC, CoLink® Plating System/CoLink® View Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion,
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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.
Substantial Equivalence: The subject components were demonstrated to be substantially equivalent to the following systems previously cleared by the FDA:
Primary Predicate
- K172300 InBones USA CoLink™ View Plating System . Additional Predicates
- K163293 In2Bones USA CoLink™ Plating System .
Reference Predicates
The subject PEEK components from CoLink® View Plating System have been shown to be substantially equivalent to the previously cleared devices cleared under K163293 and K172300 as the products are identical in indications, materials and geometry.
Performance Testing: No additional mechanical testing or validations were required to establish substantial equivalence.
Conclusion
Based on the material information provided for Invibio and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices.