Search Results

The Suture Arrow is indicated for use in repairs of knee meniscus tears that would otherwise be considered for standard repair using suture .

The Suture Arrow is a sterile, single-use, meniscal repair device, which consists of two bioabsorbable, implantable arrow-like device (hereafter referred to as "arrows"), one smooth (primary) and one barbed (secondary) joined by a suture. The primary "arrow" has a smooth surface for lateral penetration through the meniscus. The secondary "arrow" is covered with 4 circumferentially spaced rows of 3 barbs each. The barbs in each row are spaced longitudinally over the surface. The barbs are designed to anchor the secondary "arrow" implant in the meniscal tissue thereby reducing the possibility of loosening and migration of the implant. The "arrows" are pre-threaded with a single strand of braided USP #0 nonabsorbable polyester suture. The suture is immovably attached to each "arrow" by inserting the suture through an eyelet on each "arrow" and knotting the suture. The implant has different suture lengths: 16mm and 20mm. A trailing end of suture is provided to aid in the manipulation of the implant. The implant is designed to permit an all inside meniscal repair to reduce the risk of injury to the posteromedial and posterolateral neurovascular knee structures. The "arrows" are made from a copolymer derived from poly-80L/20D, L-lactide. When properly used, in the presence of adequate immobilization, the implant maintains proper fixation of the meniscal tear. As the tear of the meniscus heals, the "arrows" gradually lose strength over 20 - 35 weeks in vivo (depending on patient variables). Complete biodegradation and chemical resorption of the "arrows" may take a few years post-operatively. The Suture Arrow implant is sterile, inert and non-collagenous. Teleflex Inc.,600 Airport Road, Fall River, MA 02720, USA, supplies the suture. The Suture Arrow implant is inserted into the tissue using a sterile, singlepatient use, disposable instrument, the Arrow Inserter. The Arrow Inserter is designed to deliver each "arrow" at the appropriate site in the tissue. The Inserter handle is made of an injection-molded polycarbonate and contains internal components made from injection molded polycarbonate and 20% glass-filled polypropylene. The handle is affixed to a stainless steel cannulated needle. The cannulated needle can be manipulated to facilitate precise positioning of the "arrows" at the tip of the needle for precise delivery into the tissue. The tip of the needle is beveled, angled and sharpened for penetration into the meniscus. There are two sets of depth markers on the cannulated needle. The proximal-most set are positioned at 19mm, 24mm, 29mm and 34 mm from the tip to facilitate placement of the distal "arrow". The markers of the distal-most set are positioned at 6mm, 8mm and 10mm from the tip to facilitate placement of the secondary "arrow". To prepare the Inserter for loading, the white release button on the handle is depressed to allow the user to move the cannulated needle to the open position. The open position allows the slot on the cannulated needle to be exposed. Opening the cannulated needle enables the user to insert the implant into the slot of the needle. The implant is placed into the slot with the primary and secondary "arrows" lined up behind one another. Depressing the white button again closes the cannulated needle and moves the primary "arrow" from the slot to the tip for delivery while simultaneously advancing the secondary "arrow" forward. The Arrow Inserter is positioned in the meniscus so the first "arrow" can be deployed on the exterior of the meniscus by pulling back the black finger tab to retract the cannulated needle. The needle is then removed from the meniscus and the tip is positioned for deploying the secondary "arrow" though the tear. The secondary "arrow" is positioned in the cannulated needle by depressing the white release button. The secondary "arrow" is then deployed by pulling back the black finger tab again. Repair of a meniscal tear may require more than one Suture Arrow implant. The process is repeated for additional implants. The Suture Arrow must be loaded on the Arrow Inserter. To facilitate loading, the Suture Arrow implant is supplied on a disposable, polycarbonate loader. The Arrow Inserter is supplied with a sterile peel-away protective sleeve to protect surrounding tissue from the sharp tip of the cannulated needle. The Inserter can be manipulated into position with the protective sleeve which can be peeled off when it is not needed. The Arrow Inserter and the protective sleeve can be used multiple times on a single patient. A non-sterile, reusable, stainless steel knot pusher is also available to push the secondary arrow deeper in the meniscal tissue and tighten the suture if necessary.

The provided text is related to a 510(k) premarket notification for a medical device called "Suture Arrow." This document is a summary of safety and effectiveness and correspondence from the FDA regarding substantial equivalence. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on:

• Device Description: Details about the Suture Arrow, its components, materials, and how it is used.
• Intended Use: Specifically for repairs of knee meniscus tears.
• Substantial Equivalence: Comparing the Suture Arrow to legally marketed predicate devices (Arthrex Meniscal Dart System and Contour Meniscus Arrow) based on design, intended use, and materials.
• FDA Clearance: A letter from the FDA stating that the device is substantially equivalent to marketed predicate devices and thus can be marketed.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving the device meets them, as this data is not present in the provided text.

To answer your request, I would need a different type of document, such as a full clinical study report, a verification and validation report, or a design control document that outlines specific performance requirements and testing results.

Ask a specific question about this device