(90 days)
No
The summary describes a mechanical plating system for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is a plating system indicated for anterior fixation of ankle arthrodesis and fractures, which are medical treatments for conditions affecting the musculoskeletal system.
No
The device is a fusion plate and screw system intended for anterior fixation of ankle arthrodesis and fractures, not for diagnosing conditions.
No
The device description explicitly states it includes "sterile fusion plates and screws," which are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The provided text describes a surgical implant (plates and screws) used for fixing bones in the ankle. This is a device that is surgically placed inside the body, not used to test samples outside the body.
- Intended Use: The intended use is for "anterior fixation of ankle arthrodesis and fractures," which is a surgical procedure.
Therefore, based on the description and intended use, the CoLink® NeoFuse MIS Plating System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CoLink® NeoFuse MIS 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 posterior compression screw and a fully threaded screw through the tibiotalar joint (example CoLag 6.7mm screw) are required for ankle fusion procedure.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The CoLink® NeoFuse MIS 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 a line extension of 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)
Testing was conducted per a modified ASTM F382 set up for the plates for the CoLink NeoFuse MIS Plating System and the plates were found to be substantially equivalent. The test setup was modified from ASTM F382 to more accurately simulate anticipated mechanical loading on the plate in vivo. No additional mechanical testing was required for the screws. The CoLink NeoFuse MIS 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): 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
August 13, 2024
In2Bones USA Christine Scifert VP of Quality Assurance & Regulatory Affairs 6000 Poplar Ave. Suite 115 Memphis, Tennessee 38119
Re: K241387
Trade/Device Name: CoLink NeoFuse MIS 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: May 13, 2024 Received: May 15, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements. the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combinationproducts/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-reportmedical-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/medical-devices/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuingeducation/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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumereducation-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Christopher Ferreira -S
Christopher Ferreira, M.S. 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
2
Indications for Use
510(k) Number (if known) K241387
Device Name CoLink® NeoFuse MIS Plating System
Indications for Use (Describe)
The CoLink® NeoFuse MIS 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 posterior compression screw and a fully threaded screw through the tibiotalar joint (example CoLag 6.7mm screw) are required for ankle fusion procedure.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K241387 510(k) Summary
CoLink® NeoFuse MIS Plating System August 12, 2024
| Company: | In2Bones USA, LLC
6000 Poplar Ave, Suite 115
Memphis, TN 38119
901-260-7931 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Christine Scifert |
| Trade Name: | CoLink® NeoFuse MIS 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 CoLink® NeoFuse MIS Plating System includes sterile fusion plates and Device Description: 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 a line extension of the CoLink® NeoFuse Plating System.
Indications for Use:
The CoLink® NeoFuse MIS 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 posterior compression screw and a fully threaded screw through the tibiotalar joint (example CoLag 6.7mm screw) are required for ankle fusion procedure.
4
Substantial Equivalence: The subject components were demonstrated to be substantially equivalent to the following systems previously cleared by the FDA:
Primary Predicate
-
. K213069 – In2Bones CoLink® NeoFuse Plating System
Additional Predicate -
K173121 In2Bones SAS NeoFuse Ankle Fusion Plating System .
Reference Devices -
K181113 In2Bones CoLink® Afx Plating System .
-
. K170518 – In2Bones Fracture and Correction System
-
. K213698 – In2Bones CoLink® PCR Plating System
A comparison of the technological similarities and differences between the subject and predicate devices is shown below.
| Device | CoLink® NeoFuse MIS Plating System
(Subject Device) | CoLink® NeoFuse Plating System
(K213069) | 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 MIS Plating
System is a fusion plate indicated for
anterior fixation of ankle arthrodesis
and fractures, including the distal tibia,
talus, and calcaneus. | The CoLink® NeoFuse Plating System is
a fusion plate indicated for anterior
fixation of ankle arthrodesis and
fractures, including the distal tibia,
talus, and calcaneus. | 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 posterior compression
screw and a fully threaded screw
through the tibiotalar joint (example
CoLag 6.7mm screw) is required. | The addition of a compression screw
through the tibiotalar joint (example
CoLag 6.7mm screw) is required. | 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 configurations:
Standard and Ø3.5mm Talar Holes
Screws:
Talar fixation: Either 4.5mm, or 3.5mm
locking, non-locking or VAL screw; also
5.0mm non-locking cancellous for the
standard plate
Tibial fixation: 4.5mm locking, non-
locking or VAL screw or 5.0mm non-
locking cancellous screw | Available in 2 styles, 2 sizes each:
Anterior and Anterolateral, 3 Hole and
5 Hole.
Screws:
Talar fixation: 3.5mm locking, non-
locking or VAL screw;
Tibial fixation: 4.5mm locking, non-
locking or VAL screw;
Transverse screw: 4.5mm non-locking
screw. | Available in 1 size only
Screws:
Talar fixation: 3.5mm locking screw
with washer;
Tibial fixation: 4.5mm locking screw
with washer;
Transarticular screw: 4.5mm cortical
screw. |
| | Plate Length:1.87in
Plate Thickness: .098in -.140in
Shaft width: .410in - .453in
Talar width:.816in | Plate Length:3.10in- 4.28in
Plate Thickness: .098in -.123in
Shaft width: .460in - .492in
Talar width:.953-1.020in | Plate Length: 3.7in (94mm)
Plate Thickness: .138in (3.5mm)
Shaft width: .497in (12.54mm)
Talar width: 1.020in (25.9mm) |
5
Performance Testing: Testing was conducted per a modified ASTM F382 set up for the plates for the CoLink NeoFuse MIS Plating System and the plates were found to be substantially equivalent. The test setup was modified from ASTM F382 to more accurately simulate anticipated mechanical loading on the plate in vivo. No additional mechanical testing was required for the screws. The CoLink NeoFuse MIS 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.