(73 days)
Mitek GII Anchor
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No
The device description focuses on the mechanical properties and material of a suture anchor, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The description and intended use indicate it's a device for physically fixing suture to bone during surgical repair, not for therapeutic treatment.
No
The device description indicates that the FASTak Suture Anchor is a device for fixation of suture to bone, used in repairing rotator cuff tears and Bankart lesions. It is a therapy device (e.g., provides a physical repair or treatment), not a diagnostic one.
No
The device description clearly describes a physical, implantable suture anchor made of Titanium 6Al-4V alloy, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "fixation of suture to bone" for surgical repair of rotator cuff tears and Bankart lesions. This is a surgical implant used directly in the body.
- Device Description: The description details a physical anchor made of titanium alloy, designed for mechanical fixation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are used in vitro (outside the body) to diagnose or monitor conditions.
This device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The FASTak Suture Anchor is intended for fixation of suture to bone. This product is intended for use in repairing rotator cuff tears and Bankart lesions.
Product codes
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Device Description
The FASTak is a self tapping, threaded anchor with an eyelet for holding suture. The largest suture size used with this device is a single strand of #2. Therefore, in order for the anchor to be effective, it must have a pull-out strength greater than the tensile strength of #2 suture (~ 15 lbs.). The pull-out strength of the FASTak in cortical bone as well as cancellous is at least 38 lbs. and thus provides an acceptable factor of safety. In addition to fulfilling the requirements of a suture anchor, the FASTak also offers the advantage of a self tapping design which eliminates the need for predrilling. In a single motion, the tissue is grasped, shifted and the FASTak inserted. The result is a technique which is both easier and more reproducible. The FASTak is made of Titanium 6Al-4V alloy (ASTM F136-92). The biocompatibility of this alloy has been well documented.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Mitek GII Anchor
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted 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 a logo with the word "threx" in a stylized font. The "x" in "threx" is designed to resemble a pair of surgical scissors. The scissors are positioned diagonally, with the blades open and the handles forming the upper part of the letter "x". There is a horizontal line under the word "threx".
510(k) Summary
1/26/96
R 1 8 BOG
| Company: | Arthrex, Inc. |
|---|---|
| Address: | 3050 N. Horseshoe Drive, Naples, FL 33942 |
| Phone: | (941) 643-5553 |
| Fax: | (941) 643-6218 |
| Contact: | Scott M. Durlacher, Regulatory Affairs and Q.A. Manager (ext. 117) |
| Trade Name: | Arthrex FASTak Suture Anchor |
|---|---|
| Common Name: | Suture Anchor |
| Classification: | Screw, Fixation, Bone (per 21 CFR 888.3040) |
Description:
The FASTak is a self tapping, threaded anchor with an eyelet for holding suture. The largest suture size used with this device is a single strand of #2. Therefore, in order for the anchor to be effective, it must have a pull-out strength greater than the tensile strength of #2 suture (~ 15 lbs.). The pull-out strength of the FASTak in cortical bone as well as cancellous is at least 38 lbs. and thus provides an acceptable factor of safety. In addition to fulfilling the requirements of a suture anchor, the FASTak also offers the advantage of a self tapping design which eliminates the need for predrilling. In a single motion, the tissue is grasped, shifted and the FASTak inserted. The result is a technique which is both easier and more reproducible.
The FASTak is made of Titanium 6Al-4V alloy (ASTM F136-92). The biocompatibility of this alloy has been well documented.
Intended Use:
The FASTak Suture Anchor is intended for fixation of suture to bone. This product is intended for use in repairing rotator cuff tears and Bankart lesions.
Substantial Equivalence:
The Arthrex FASTak Suture Anchor is substantially equivalent to the Mitek GII Anchor. By definition, substantial equivalence means that a device has the same intended use and the same technological characteristics as the predicate device, or has the same intended use and different technological characteristics, but it can be demonstrated that the device is as safe and effective as the predicate device and does not raise different questions regarding safety and effectiveness from the predicate device. Our device has the same intended use as the Mitek GII, but different technological characteristics. The GII uses nitinol barbs as the method of fixation, whereas the FASTak has threads. Although there are slight differences in pull-out strength between the two, the critical value is the tensile strength of the suture. Since the pull-out strength of the FASTak is greater than the tensile strength of suture, it fulfills the secondary requirement for substantial equivalence.