Need Help! would you consider a fast fix kit a supply or implant?
A surgeon used a fast fix kit for a meniscal tear and the cost of the kit was $2,000. My staff and the sales rep consider this kit as a device because their brochure states it uses achors. this kit provides for more minimially invasive approach. i tried to download the brochure to learn more about it (i cut and pasted some of the text below), but you can find it on a website at: www.ortovit.eu/ortopedie/artroscopie/doc/Tehnica FastFix360.pdf
the text from the brochure is:
Each FAST-FIX™ 360 Meniscal Repair System contains two 5 mm polymer integrated bio-inert anchors (PEEK-OPTIMA® from Invibio®) with a pretied, self-sliding knot comprised of 2-0, non-absorbable, UHMW polyethelene ULTRABRAID™ Suture. The entire system is packaged in an easy-to-insert integrated delivery needle. The delivery needles are available in curved, straight, and reverse curved designs (Figure 2). The curved and
reverse curved designs allow the surgeon to rotate the needle tip away from the neurovascular structures when penetrating the meniscus, further reducing the risk of neurovascular injury. The curved delivery needle is optimally shaped to allow vertical mattress sutures to be inserted on either the femoral or tibial surfaces of the meniscus.
The reverse curved delivery needle is most useful for repairing tears on the tibial surface and more anterior located tears. The anchors are placed into the meniscus sequentially and are seated safely outside the capsule. The suture
is then tensioned in a simple manner without the need for arthroscopic knot tying.
A surgeon used a fast fix kit for a meniscal tear and the cost of the kit was $2,000. My staff and the sales rep consider this kit as a device because their brochure states it uses achors. this kit provides for more minimially invasive approach. i tried to download the brochure to learn more about it (i cut and pasted some of the text below), but you can find it on a website at: www.ortovit.eu/ortopedie/artroscopie/doc/Tehnica FastFix360.pdf
the text from the brochure is:
Each FAST-FIX™ 360 Meniscal Repair System contains two 5 mm polymer integrated bio-inert anchors (PEEK-OPTIMA® from Invibio®) with a pretied, self-sliding knot comprised of 2-0, non-absorbable, UHMW polyethelene ULTRABRAID™ Suture. The entire system is packaged in an easy-to-insert integrated delivery needle. The delivery needles are available in curved, straight, and reverse curved designs (Figure 2). The curved and
reverse curved designs allow the surgeon to rotate the needle tip away from the neurovascular structures when penetrating the meniscus, further reducing the risk of neurovascular injury. The curved delivery needle is optimally shaped to allow vertical mattress sutures to be inserted on either the femoral or tibial surfaces of the meniscus.
The reverse curved delivery needle is most useful for repairing tears on the tibial surface and more anterior located tears. The anchors are placed into the meniscus sequentially and are seated safely outside the capsule. The suture
is then tensioned in a simple manner without the need for arthroscopic knot tying.
