(97 days)
Not Found
No
The description focuses on the mechanical properties and intended use of a physical orthopedic fixation device. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to provide fixation and assist in the healing process following a syndesmotic trauma, which directly relates to treating or mitigating a disease or injury.
No
The device is an orthopedic fixation device intended to provide fixation during the healing process, not to diagnose a condition.
No
The device description clearly states it is a "multiple-anchor orthopedic fixation device system" made of stainless steel or titanium, and includes anchors, installation tools, a Kirschner wire, and a drill bit. These are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an orthopedic fixation system used to repair bone fractures and provide fixation during the healing process. This is a surgical device used in vivo (within the body).
- Device Description: The description details a system of anchors, tools, and wires for surgical implantation.
- Anatomical Site: The device is used on the ankle syndesmosis, tibia, and fibula, which are anatomical structures within the body.
- Performance Studies: The performance studies described are related to the mechanical properties and biocompatibility of the implanted device, not diagnostic testing of biological samples.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Akros FibuLink™ Syndesmosis Repair Kit is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated and as an adjunct to fixation systems involving plates, with fracture braces and casting. Specifically, the Akros FibuLink™ Syndesmosis Repair Kit is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.
Product codes
HTN
Device Description
The Akros FibuLink™ Syndesmosis Repair Kit is a multiple-anchor orthopedic fixation device system, offered in both a stainless steel and a titanium version. The system is designed as an adjunct in repair of unstable joints, specifically as a means to provide fixation between the tibia and fibula during the healing process following a disruption of the ankle syndesmosis. If a fracture of the fibula is present, the design of the fibula anchor permits placement through any fibula fracture repair plate that can accept a 3.5mm cortical screw conforming to ASTM F543-13. The anchors are provided pre-threaded and pre-loaded on their installation tools in a one-time-use pre-sterilized kit, with the Kirschner wire and drill bit needed for site preparation included.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle, syndesmosis, tibia, fibula
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)
Simulated use, lateral pull-to-failure, offset load-to-failure, insertion torque-to-failure, fatigue with pull-to-failure, fretting, pitting corrosion, magnetic resonance, cytotoxicity, pyrogenicity and endotoxin testing were conducted. The results of these tests indicate that the performance of the FibuLink™ device is adequate for its intended use. Endotoxin results demonstrated that the FibuLink™ device met the recommended limit of
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, layered on top of each other. These profiles are connected to three flowing shapes below, resembling fabric or ribbons. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 10, 2017
Akros Medical Mr. Charles Horrell CEO and Co-Founder 3503 Pleasant Green Rd Durham, North Carolina 27705
Re: K162805 Trade/Device Name: Akros FibuLink Syndesmosis Repair Kit 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: December 9, 2016 Received: December 12, 2016
Dear Mr. Horrell:
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,
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
K162805 510(k) Number (if known): _
Device Name: Akros FibuLink™ Syndesmosis Repair Kit
Indications for Use:
The Akros FibuLink™ Syndesmosis Repair Kit is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated and as an adjunct to fixation systems involving plates, with fracture braces and casting. Specifically, the Akros FibuLink™ Syndesmosis Repair Kit is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.
Prescription Use _X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ AND/OR (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)
Page 1 of 1
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510(k) Summary
| Prepared: | September 30, 2016 |
|---|---|
| Submitter: | Akros Medical |
| 3503 Pleasant Green Rd | |
| Durham, NC 27705 | |
| Contact: | Charles Horrell |
| Chief Executive Officer and Co-Founder | |
| 248.259.5535 | |
| chuck@akrosmedical.com | |
| Proprietary Name: | Akros FibuLink™ Syndesmosis Repair Kit |
| Common Name: | Syndesmosis Repair Kit |
| Regulation and Class: | 21 CFR 888.3030 Single/multiple component metallic bone |
| fixation appliances and accessories; Class II | |
| Product Code: | 87/HTN |
| Predicate Device: | • Arthrex TightRope™ Syndesmosis Device, K043248 |
Device Description:
The Akros FibuLink™ Syndesmosis Repair Kit is a multiple-anchor orthopedic fixation device system, offered in both a stainless steel and a titanium version. The system is designed as an adjunct in repair of unstable joints, specifically as a means to provide fixation between the tibia and fibula during the healing process following a disruption of the ankle syndesmosis. If a fracture of the fibula is present, the design of the fibula anchor permits placement through any fibula fracture repair plate that can accept a 3.5mm cortical screw conforming to ASTM F543-13. The anchors are provided pre-threaded and pre-loaded on their installation tools in a one-time-use pre-sterilized kit, with the Kirschner wire and drill bit needed for site preparation included.
Intended Use / Indications:
The Akros FibuLink™ Syndesmosis Repair Kit is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated and as an adjunct to fixation systems involving plates, with fracture braces and casting. Specifically, the Akros FibuLink™ Syndesmosis Repair Kit is intended to provide fixation during the healing process
4
following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.
Summary of Technologies/Substantial Equivalence:
The FibuLink™ Syndesmosis Repair Kit is substantially equivalent to the predicate device in terms of its intended use and indications, materials, basic design and mechanical performance. Any noted differences do not raise new types of safety and effectiveness questions, nor are there new technological issues.
Non-Clinical Testing:
Simulated use, lateral pull-to-failure, offset load-to-failure, insertion torque-to-failure, fatigue with pull-to-failure, fretting, pitting corrosion, magnetic resonance, cytotoxicity, pyrogenicity and endotoxin testing were conducted. The results of these tests indicate that the performance of the FibuLink™ device is adequate for its intended use. Endotoxin results demonstrated that the FibuLink™ device met the recommended limit of