(89 days)
Not Found
No
The device description and performance studies focus on mechanical properties and surgical fixation, with no mention of AI/ML terms or functionalities.
Yes.
The device is intended to provide fixation during the healing process following syndesmotic trauma, which directly contributes to the restoration of health.
No
The device is described as a fixation system for acromioclavicular separations, providing reduction and stabilization. Its purpose is to aid in the healing process, not to diagnose a condition.
No
The device description clearly outlines physical components made of PET, titanium, or stainless steel, and mentions accessory instruments, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide fixation during the healing process of acromioclavicular separations. This is a surgical intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is a suture band system designed for surgical implantation to stabilize a joint. This is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or any diagnostic purpose.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The M-Fix™ Acromioclavicular Device does not fit this description.
N/A
Intended Use / Indications for Use
The M-FixTM Acromioclavicular Device is intended to provide fixation during the healing process following syndesmotic trauma such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.
Product codes (comma separated list FDA assigned to the subject device)
HTN
Device Description
The M-Fix™ Acromioclavicular Device (M-Fix™) is a suture band system designed to provide reduction and stabilization of the acromioclavicular joint following syndesmotic disruptions. The M-Fix is a polyethylene terephthalate (PET) band that may be tensioned and secured with the integrated, low-profile Connector/Button which is made of titanium or stainless steel.
The one-time use band with connector is provided sterile. Additional accessory instruments, including a Counter Traction Tool and a Punch Tool for securing the Connector/Button are single use devices provided sterile for use during the orthopedic procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Acromioclavicular joint
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)
Design verification activities were performed as a result of the risk analysis. The 510(k) notice contains summaries of bench studies, which were conducted to evaluate the performance characteristics of the M-FixTM . Ultimate Tensile and Cyclic Tests were performed. The information presented demonstrates that the M-FixTM Acromioclavicular Device is substantially equivalent to the predicate devices.
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.
Not Found
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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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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them that resemble fabric or water.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 2, 2016
Coracoid Solutions, Inc. % Michael Kolber Consultant, Regulatory Affairs Michael Kolber 337 Ester Ave Campbell, California 94025
Re: K153211 Trade/Device Name: M-Fix Acromioclavicular Device Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN Dated: November 4, 2015 Received: November 5, 2015
Dear Michael Kolber:
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
1
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 yours,
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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Image /page/2/Picture/1 description: The image contains the logo for Coracoid Solutions. The logo consists of a stylized letter "C" and "S" intertwined, with the "C" in blue and the "S" in green. To the right of the logo are the words "CORACOID" and "SOLUTIONS" stacked on top of each other, both in a light blue color.
Indications for Use
510(k) Number (if known): _K153211
Device Name: Coracoid Solutions, M-Fix™ Acromioclavicular Device
Indications for Use: The M-Fix™ Acromioclavicular Device is intended to provide fixation during the healing process following syndesmotic trauma such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Image /page/3/Picture/1 description: The image contains the logo for Coracoid Solutions. The logo consists of two intertwined letter C's, one in blue and one in green. To the right of the logo is the company name, "CORACOID" in blue, with "SOLUTIONS" underneath it, also in blue.
510(k) Summary (per 21CFR807.92)
| General Company Information | ||
|---|---|---|
| Name: | Coracoid Solutions, LLC | |
| Contact: | Michael Kolber | |
| Regulatory Affairs | ||
| Address: | 15 Normans Way | |
| Park City, UT 84060 | ||
| Telephone: | 408-505-6626 | |
| Fax: | 408-608-0338 | |
| Date Prepared: | November 4, 2015 | |
| General Device Information | ||
| Product Name: | M-FixTM Acromioclavicular Device | |
| Common Name: | Button/Suture | |
| Classification Name: | Washer, Bolt Nut | |
| Regulation Number: | 21CFR888.3030, Single/multiple component metallic bone | |
| fixation appliances and accessories | ||
| Device Class: | Class II | |
| Product Code: | HTN | |
| Predicate Devices | ||
| Manufacturer | Device Name | 510(k) Number |
| Arthrex, Inc. | TightRopeTM Acromioclavicular (AC) Device | K052776 |
| Surgicraft, Ltd. | LockdownTM Acromioclavicular (AC) Device | K091207 |
| Dallen Medical, Inc. | TensynTM Band | K131850 |
| Description |
The M-Fix™ Acromioclavicular Device (M-Fix™) is a suture band system designed to provide reduction and stabilization of the acromioclavicular joint following syndesmotic disruptions. The M-Fix is a polyethylene terephthalate (PET) band that may be tensioned and secured with the integrated, low-profile Connector/Button which is made of titanium or stainless steel.
The one-time use band with connector is provided sterile. Additional accessory instruments, including a Counter Traction Tool and a Punch Tool for securing the Connector/Button are single use devices provided sterile for use during the orthopedic procedure.
Intended Use (Indications)
The M-Fix Acromioclavicular Device is intended to provide fixation during the healing process following syndesmotic trauma such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.
Substantial Equivalence
This submission supports the position that the Coracoid Solutions M-Fix is substantially equivalent to the Arthrex TightRope™ Acromioclavicular (AC) Device (K052776), the
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Image /page/4/Picture/1 description: The image shows the logo for Coracoid Solutions. The logo consists of two intertwined letter C's, one in blue and one in green, with the green C appearing to be in front of the blue C. To the right of the intertwined C's is the text "CORACOID" in blue, with the text "SOLUTIONS" in blue below it. The logo is simple and modern, and the use of blue and green gives it a clean and professional look.
Surgicraft Lockdown™ Acromioclavicular (AC) Device (K091207), and the Dallen Medical Tensyn™ Band (K131850). The M-Fix™ has the following similarities to the previously cleared predicate devices: the same or similar intended use, same operating principle, similar technologies, and similar manufacturing process. Design verification activities were performed as a result of the risk analysis. The 510(k) notice contains summaries of bench studies, which were conducted to evaluate the performance characteristics of the M-Fix™ . Ultimate Tensile and Cyclic Tests were performed. The information presented demonstrates that the M-Fix™ Acromioclavicular Device is substantially equivalent to the predicate devices.
Conclusions
Coracoid Solutions, LLC believes that the information provided demonstrates that the proposed device is substantially equivalent to the predicate devices and does not raise any new issues of safety or efficacy. Based on the indications for use, technological characteristics, and comparison to predicate devices, the M-Fix has been shown to be substantially equivalent to predicate devices as described under the Federal Food, Drug and Cosmetic Act.