FASTAK SUTURE ANCHOR

K960516 · Arthrex, Inc. · MBI · Apr 18, 1996 · Orthopedic

Device Facts

• Record ID: K960516
• Device Name: FASTAK SUTURE ANCHOR
• Applicant: Arthrex, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Apr 18, 1996
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Self-tapping, threaded titanium suture anchor; includes eyelet for suture attachment. Used by surgeons in orthopedic procedures (rotator cuff repair, Bankart lesion repair). Device inserted into bone to anchor suture; eliminates predrilling requirement. Pull-out strength (>38 lbs) exceeds tensile strength of #2 suture (~15 lbs), ensuring secure fixation. Simplifies surgical technique; improves reproducibility of tissue grasping and shifting.

Clinical Evidence

Bench testing only; pull-out strength testing performed to verify fixation security relative to suture tensile strength.

Technological Characteristics

Material: Titanium 6Al-4V alloy (ASTM F136-92). Design: Self-tapping, threaded anchor with suture eyelet. Fixation principle: Mechanical threading into bone.

Indications for Use

Indicated for fixation of suture to bone in patients requiring repair of rotator cuff tears and Bankart lesions.

Regulatory Classification

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.

Predicate Devices

• Mitek GII Anchor

Submission Summary (Full Text)

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Threx
K960516

# 510(k) Summary

1/26/96
APR 18 1996

Company: Arthrex, Inc.
Address: 3050 N. Horseshoe Drive, Naples, FL 33942
Phone: [phone]
Fax: [phone]
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.

Threx Inc. • 3050 North Horseshoe Drive • Naples FL 33942 • Tel: [phone] • Fax [phone]