(101 days)
Not Found
No
The summary describes a mechanical plating system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is indicated for fixational osteotomies and corrective procedures, which are structural interventions rather than direct therapeutic treatments.
No
The device is a plating system used for surgical fixation and correction of hallux and associated disorders, not for diagnosing them.
No
The device description explicitly states it includes a plate, screws, and surgical instruments, which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fixational osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a "plate and screws and surgical instruments used to treat Hallux Valgus and reconstruction of bone for bunion corrections." 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 in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
The In2Bones USA, CoLink Vallux Plating System is indicated for fixational osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.
Product codes
HRS, HWC
Device Description
The In2Bones CoLink Vallux Plating System includes a plate and screws and surgical instruments used to treat Hallux Valgus and reconstruction of bone for bunion corrections. These subject devices are part of the overarching CoLink® Plating System and will be commonly referred to as the CoLink Vallux Plating System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hallux
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
No additional mechanical testing was required for the CoLink Vallux Plating System. The 2.4mm and 2.7mm screws are identical to previously cleared screws and no new worst-case plate or screws were added. A rationale was conducted related to the CoLink Plating System, CoLink Mini Plating System and the In2Bones Kirschner Wire related to four-point bend testing per ASTM F382 to show the subject plate is substantially equivalent to the predicate plates. The CoLink Vallux Plating System was adopted into previously provided sterilization, packaging and endotoxin validations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K163293, K181872, K153204, K191535, K181113
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.
0
November 18, 2021
Image /page/0/Picture/1 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.
In2Bones USA, LLC Christine Scifert VP of Quality and Regulatory 6000 Poplar Ave, Suite 115 Memphis, Tennessee 38119
Re: K212487
Trade/Device Name: CoLink Vallux 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 6, 2021 Received: August 9, 2021
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
1
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, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212487
Device Name CoLink Vallux Plating System
Indications for Use (Describe)
The In2Bones USA, CoLink Vallux Plating System is indicated for fixational osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.
| 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)
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510(k) Summary
CoLink Vallux Plating System November 18, 2021
| Company: | In2Bones USA, LLC
6000 Poplar Ave, Suite 115
Memphis, TN 38119
901-260-7931 |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Christine Scifert |
| Trade Name: | CoLink Vallux Plating System |
| Common Name: | Plate, Fixation, Bone (Primary)
Screw, Fixation, Bone |
| Classification: | II |
| Regulation Number: | 888.3030 (Primary) - 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 (Primary), HWC |
Device Description: The In2Bones CoLink Vallux Plating System includes a plate and screws and surgical instruments used to treat Hallux Valgus and reconstruction of bone for bunion corrections. These subject devices are part of the overarching CoLink® Plating System and will be commonly referred to as the CoLink Vallux Plating System.
The In2Bones USA, CoLink Vallux Plating System is indicated for fixation of Indications for Use: translational osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.
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
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Additional Predicates
- K181872 CrossRoads MiniBunion® .
- . K153204 – In2Bones Kirschner Wire
- K191535 In2Bones CoLink® Mini Plating System ●
- K181113 In2Bones CoLink® Afx Plating System ●
The subject CoLink Vallux Plating System is made of Titanium Alloy and 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: No additional mechanical testing was required for the CoLink Vallux Plating System. The 2.4mm and 2.7mm screws are identical to previously cleared screws and no new worst-case plate or screws were added. A rationale was conducted related to the CoLink Plating System, CoLink Mini Plating System and the In2Bones Kirschner Wire related to four-point bend testing per ASTM F382 to show the subject plate is substantially equivalent to the predicate plates. The CoLink Vallux Plating System was adopted into previously provided sterilization, packaging and endotoxin validations.
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.