(81 days)
No
The summary describes a mechanical plating system for bone fixation and makes no mention of AI or ML.
Yes
Explanation: The device is indicated for anterior fixation of ankle arthrodesis and fractures, which are therapeutic interventions.
No
The device description and intended use clearly state that it is a plating system for anterior fixation of ankle arthrodesis and fractures, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it includes "sterile fusion plates and screws," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for anterior fixation of ankle arthrodesis and fractures. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as sterile fusion plates and screws, which are implants 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 screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The CoLink® NeoFuse Plating System is indicated for anterior fixation of ankle arthrodesis and fractures, including the distal tibia and talus.
The addition of a compression screw through the tibiotalar joint (example CoLag 6.7mm screw) is required.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The In2Bones CoLink® NeoFuse Plating System includes sterile fusion plates and screws for anterior fixation of ankle arthrodesis and fractures, including the distal tibia and talus. The addition of a medial-lateral compression screw through the tibiotalar joint is required. These subject devices are part of the overarching CoLink® Plating System and will be commonly referred to as the CoLink NeoFuse Plating System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle, distal tibia, talus
Indicated Patient Age Range
Not Found
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: Testing was conducted per a modified ASTM F382 set up for the plates for the CoLink® NeoFuse Plating System and the plates were found to be substantially equivalent. No additional mechanical testing was required for the screws. The CoLink® NeoFuse Plating System were 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): 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.
K173121, K163293, K121425, K181113
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.
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December 13, 2021
Image /page/0/Picture/1 description: The image shows 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: K213069
Trade/Device Name: CoLink® NeoFuse 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: September 21, 2021 Received: September 23, 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213069
Device Name CoLink® NeoFuse Plating System
Indications for Use (Describe)
The CoLink® NeoFuse Plating System is indicated for anterior fixation of ankle arthrodesis and fractures, including the distal tibia and talus.
The addition of a compression screw through the tibiotalar joint (example CoLag 6.7mm screw) is required.
| Type of Use (Select one or both, as applicable) | ☑ Residential Use (Part 21 CFR 601 Subpart E) ☐ Compassionate Use (21 CFR 601 Subpart E) |
|---|---|
| ------------------------------------------------- | --------------------------------------------------------------------------------------------------------- |
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® NeoFuse Plating System December 8, 2021
| Company: | In2Bones USA, LLC
6000 Poplar Ave, Suite 115
Memphis, TN 38119
901-260-7931 |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Christine Scifert |
| Trade Name: | CoLink® NeoFuse 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 |
Device Description: The In2Bones CoLink® NeoFuse Plating System includes sterile fusion plates and screws for anterior fixation of ankle arthrodesis and fractures, including the distal tibia and talus. The addition of a medial-lateral compression screw through the tibiotalar joint is required. These subject devices are part of the overarching CoLink® Plating System and will be commonly referred to as the CoLink NeoFuse Plating System.
Indications for Use:
The CoLink® NeoFuse Plating System is indicated for anterior fixation of ankle arthrodesis and fractures, including the distal tibia and talus.
The addition of a compression screw through the tibiotalar joint (example CoLag 6.7mm screw) is required for ankle fusion procedure.
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Substantial Equivalence: The subject components were demonstrated to be substantially equivalent to the following systems previously cleared by the FDA:
Primary Predicate
-
. K173121 – In2Bones SAS NeoFuse Ankle Fusion Plating System
Additional Predicates -
K163293 In2Bones CoLink® Plating System ●
-
K121425 Wright Ortholoc® 3Di Ankle Fusion Plating System ●
-
. K181113 – In2Bones CoLink® Afx Plating System
Reference Devices
- . K170518 - In2Bones Fracture and Correction System
- K193543 In2Bones CoLink / Fracture and Correction System Packaging ●
A comparison of the technological similarities and differences between the subject and predicate devices is shown below:
| Device | CoLink® NeoFuse Plating System
(Subject Device) | CoLink® Plating System
(K163293) | In2Bones SAS NeoFuse Ankle
Fusion Plating System
(K173121) |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Fixation Plates and Screws | Fixation Plates and Screws | Fixation Plates and Screws |
| Indications for
Use | The CoLink® NeoFuse Plating
System is a fusion plate indicated
for anterior fixation of ankle
arthrodesis and fractures,
including the distal tibia and
talus.
The addition of a compression
screw through the tibiotalar joint
(example CoLag 6.7mm screw) is
required for ankle fusion
procedure. | 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 NeoFuse Ankle
Fusion plating system is
indicated for anterior fixation of
ankle arthrodesis and fractures,
including the distal tibia, talus
and calcaneus.
The addition of a compression
screw through the tibiotalar
joint (example IBS 6.5mm
screw) is required. |
| Product Code | HRS, HWC | HRS, HWC | HRS, HWC |
| Material | Titanium Alloy (ASTM F136) | Titanium Alloy (ASTM F136) | Titanium Alloy (ASTM F136) |
| Geometry and
Dimensions | Available in 2 styles, 2 sizes each:
Anterior and Anterolateral, 3
Hole and 5 Hole. | Plate type: MTP, Lapidus, Y-
Plate, Universal Plate, H-Plate;
2-hole through 8-hole plates | Plate: Available in 1 size only
Screws: |
| | Screws:
3.5mm locking, non-locking or
VAL screw or 4.5mm locking,
non-locking or VAL screw | Screws:
3.0 and 3.5 locking and non-
locking screws | 3.5mm locking screw with
washer, 4.5mm locking screw
with washer or 4.5mm cortical
screw |
| | Plate Length:3.10in- 4.28in
Plate Thickness: .098in -.123in | Plate Length: 0.9in - 2.3in
Plate Thickness: 0.050-.064in | Plate Length: 3.7in
Plate Thickness: .138in |
The subject CoLink® NeoFuse 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.
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Performance Testing: Testing was conducted per a modified ASTM F382 set up for the plates for the CoLink® NeoFuse Plating System and the plates were found to be substantially equivalent. No additional mechanical testing was required for the screws. The CoLink® NeoFuse Plating System were 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.