(185 days)
Not Found
No
The summary describes a mechanical plating system for bone fixation and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is used for "fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones", which are therapeutic interventions.
No
The device is a plating system used for the fixation and reconstruction of small bone fractures and fusions, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it includes 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 is for the "indication 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 implant used in vivo (within the body) to treat musculoskeletal conditions.
- Device Description: The device consists of "plates and screws and surgical instruments" made of materials like Carbon Fiber Reinforced PEEK-OPTIMA™ and titanium alloy. These are physical implants and tools used in surgery.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such testing.
The information clearly indicates this is a surgical implant system, not a diagnostic test.
N/A
Intended Use / Indications for Use
The CoLink® PCR 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.
Product codes
HRS, HWC
Device Description
The In2Bones CoLink® PCR Plating System includes plates and screws and surgical instruments intended for treating fusions and fractures of the extremities. These subject devices are part of the overarching CoLink® Plating System and will be commonly referred to as the CoLink® PCR Plating System. The CoLink® PCR Plating System consists of the MTP Narrow NX and Universal style plates available in Carbon Fiber Reinforced PEEK-OPTIMA™ with Barium Sulfate. The plates are used with previously cleared 3.0mm and 3.5mm titanium alloy locking and non-locking screws.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
hand, wrist, foot and ankle.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing: The CoLink® PCR Plating System was tested in static and dynamic four-point bending per ASTM F382 to show the subject plate is substantially equivalent to the predicate plates. The 3.0mm and 3.5mm screws are identical to previously cleared screws and no new worst-case plate or screws were added. The CoLink® PCR Plating System was validated per ISO 10993-1 for biocompatibility, ISO 11137-2 for gamma sterilization and ISO 11607-1 for packaging. Endotoxin testing was completed per ANSI/AAMI ST72.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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 date May 27, 2022. The month is written out in full, followed by the day and year. The date is written in a clear, legible font.
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.
In2Bones USA, LLC Christine Scifert VP of Quality and Regulatory 6000 Poplar Ave. Suite 115 Memphis, Tennessee 38119
Re: K213698
Trade/Device Name: CoLink® PCR 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, 2022 Received: April 28, 2022
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.
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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 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
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Indications for Use
510(k) Number (if known) K213698
Device Name CoLink® PCR Plating System
Indications for Use (Describe)
The CoLink® PCR 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.
| 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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K213698 Page 1 of 2
510(k) Summary
CoLink® PCR Plating System May 25, 2022
| Company: | In2Bones USA, LLC
6000 Poplar Ave, Suite 115
Memphis, TN 38119
901-260-7931 |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Christine Scifert |
| Trade Name: | CoLink® PCR 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 (Primary)
888.3040 - Smooth or threaded metallic bone fixation fastener |
| Panel: | 87-Orthopedic |
| Product Code(s): | HRS, HWC |
The In2Bones CoLink® PCR Plating System includes plates and screws and Device Description: surgical instruments intended for treating fusions and fractures of the extremities. These subject devices are part of the overarching CoLink® Plating System and will be commonly referred to as the CoLink® PCR Plating System. The CoLink® PCR Plating System consists of the MTP Narrow NX and Universal style plates available in Carbon Fiber Reinforced PEEK-OPTIMA™ with Barium Sulfate. The plates are used with previously cleared 3.0mm and 3.5mm titanium alloy locking and non-locking screws.
Indications for Use: The CoLink® PCR 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.
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 Predicate
- K170401 CarboFix Orthopedics Piccolo Composite Plate System ●
The subject CoLink® PCR Plating System plates are similar in geometry to the previously cleared CoLink® Plating System and is made of Carbon Fiber Reinforced PEEK-OPTIMA™ with Barium Sulfate. The CoLink® PCR Plating System 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: The CoLink® PCR Plating System was tested in static and dynamic four-point bending per ASTM F382 to show the subject plate is substantially equivalent to the predicate plates. The 3.0mm and 3.5mm screws are identical to previously cleared screws and no new worst-case plate or screws were added. The CoLink® PCR Plating System was validated per ISO 10993-1 for biocompatibility, ISO 11137-2 for gamma sterilization and ISO 11607-1 for packaging. Endotoxin testing was completed per ANSI/AAMI ST72.
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.