(164 days)
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.
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.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Bacterial Endotoxin | Device meets biocompatibility requirements. | Testing performed; results demonstrate substantial equivalence. |
| Static Driving Torque | Device components (screws) can be appropriately driven without failure, supporting the intended fixation. | Testing performed; results demonstrate substantial equivalence. |
| Static Pullout | Screws maintain adequate fixation in bone material under static axial loads, ensuring stability. | Testing performed; results demonstrate substantial equivalence. |
| Static Torsion | Screws and plates withstand torsional forces without failure, relevant for rotational stability. | Testing performed; results demonstrate substantial equivalence. |
| Screw/Plate Push Through | Screws do not "push through" the plate, maintaining the integrity of the fixation construct. | Testing performed; results demonstrate substantial equivalence. |
| Static Bending | Plates and screws maintain mechanical integrity and resist deformation under static bending loads, crucial for fracture stabilization. | Testing performed; results demonstrate substantial equivalence. |
| Pullout Fixation (General) | The overall construct (plate and screws) provides secure and stable fixation in bone. | Testing performed; results demonstrate substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each mechanical test. It only generally refers to "testing" being performed. The data provenance is pre-market (regulatory submission for 510(k) clearance), suggesting it's from studies conducted by the device manufacturer, In2Bones USA, LLC. The country of origin of the data is not specified but would typically be where the manufacturer's testing facilities are located or where contract research organizations (CROs) performed the tests. The studies are prospective in nature, meaning they were designed and conducted specifically to generate data for this regulatory submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable. The device being described is a mechanical bone fixation system (plates and screws), not a diagnostic or AI-driven device that requires expert-established ground truth for performance evaluation in a clinical or imaging context. The "ground truth" for this type of device is established through engineering and mechanical testing standards and simulations rather than expert consensus on clinical findings.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons mentioned in point 3. The evaluation of mechanical test results typically involves adherence to recognized standards and objective measurements, not adjudication by human experts in the way clinical studies are adjudicated.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic devices or AI algorithms that assist human readers in interpreting medical images or data. The Colink™ Plating System is a surgical implant, and its effectiveness is assessed through mechanical testing and, if applicable, clinical performance data (which is not detailed here beyond the substantial equivalence claim).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The Colink™ Plating System is a physical medical device, not an algorithm. Therefore, there is no "standalone" algorithm-only performance to assess.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation is established through objective, standardized mechanical testing data (e.g., measurements of force, torque, displacement) against pre-defined engineering specifications and relevant industry standards for orthopedic implants. It is not based on expert consensus, pathology, or outcomes data in the context of this 510(k) summary, which focuses on substantial equivalence based on technological characteristics and mechanical performance.
8. The Sample Size for the Training Set
This information is not applicable. The Colink™ Plating System is an orthopedic implant, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data acquisition for AI model development.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the reasons mentioned in point 8.
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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
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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, LLC6060 Poplar Avenue, Suite 380Memphis, TN 38119 |
| Phone: | 901-260-7931 |
| Contact Person: | Louise Focht |
II. Device
| Proprietary Name: | Colink™ Plating System |
|---|---|
| Common Name: | Plate, Fixation, BoneScrew, Fixation, Bone |
| Classification Name: | Single/multiple component metallic bone fixationappliances and accessoriesSmooth or threaded metallic bone fixation fastener. |
| Regulatory Class: | 21 CFR 888.3030, Class II21 CFR 888.3040, Class II |
| Product Code: | 87 HRS, HWC |
III. Predicate Device
| Predicate Device: | Stryker (Memometal) Anchorage Bone Plate System,K083447Integra Total Foot System, K123000 |
|---|---|
| Reference Device: | In2Bones SAS, I.B.S. Osteosynthesis screws, K131920In2Bones USA, RTS System, K153609In2Bones 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.
§ 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.