BROCHURE - ARTHROFIX

Product catalog summary

Introduction
The document describes the ARTHROFIX bioabsorbable suture anchor, designed for rotator cuff repair and biceps tenodesis. It is a medical device manufactured by TEKNIMED, classified as Class III, and is CE marked.

Composition and Material
The suture anchor is made from a bioabsorbable biocomposite polymer consisting of 70% Polylactic Acid (PLA) and 30% tricalcium phosphate (TCP). The TCP particles are sub-micron sized, homogeneously distributed, and agglomerate-free, enhancing bone integration and maintaining a neutral pH to increase resorption speed.

Design and Features
The ARTHROFIX anchor is mounted on a single-use screwdriver with two sutures made of Ultra High Molecular Weight Polyethylene (UHMWPE). It features a double thread design for increased pull-out strength and high mechanical properties due to the homogeneous distribution of TCP particles.

Advantages
The suture offers high tensile strength, smooth knot sliding, and prevents entanglement. It provides superior knot break strength and tighter loop security compared to competitors.

Resorption and Mechanical Properties
The anchor maintains mechanical properties for six months and becomes undetectable after 24 months. The PLA material degrades through hydrolysis, and TCP particles increase the resorption speed.

Storage and Handling
ARTHROFIX must be stored in its original unopened packaging at ambient temperature (maximum 37°C) and is sterilized by ethylene oxide. It is intended for single use and should not be re-sterilized.

Product Specifications
The document lists the available sizes and references for the ARTHROFIX anchors and corresponding taps.

Recommendations
Health professionals are advised to read the labels and Instructions for Use (IFU) before using the product. Instrumentation for arthroscopic procedures is available, and ARTHROFIX must be used with the corresponding tap supplied by VIMS.

Catalog excerpts

BIOABSORBABLE ANCHOR BIOABSORBABLE SUTURE ANCHOR

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BIOABSORBABLE SUTURE ANCHOR BIOABSORBABLE SUTURE ANCHOR It is specially designed for rotator cuff repair and biceps tenodesis. COMPOSITION Bioabsorbable biocomposite polymer: 70% PLA (Polylactic Acid) 30% of -TCP (tricalcium phosphate). -TCP particles are sub-micron sized and homogenously distributed within the PLA matrix, in addition, they are agglomerates free for a better bone integration. TCP keeps a neutral PH by buffer effect, the resorption speed is thus increased without risk of ARTHROFIX is a bioabsorbable suture anchor mounted on a single-use screwdriver assembled with two sutures composed...

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BIOABSORBABLE SUTURE ANCHOR PROPERTIES Its double thread allows an increase of the pull out strength of the anchor. High mechanical properties improved by the homogeneous distribution of the TCP particles within the PLA matrix. The USP2 sutures are made of UHMWPE (Ultra High Molecular Weight Poly Ethylene) Each suture is maintened in a dedicated handle which prevents them from becoming tangled. Biocompatible Controlled resorption speed thanks to PLA material which degrades through hydrolysis and TCP particules which increase resorption speed. PROPERTIES - High tensile strength - Suture material...

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BIOABSORBABLE SUTURE ANCHOR STORAGE ARTHROFIX must be stored in its original unopened packaging, in a clean and dry place, at ambient temperature (maximum 37°C). PRODUCTS & INSTRUMENTATION ARTHROFIX anchor is packaged in a blister itself sealed in an aluminum pouch and sterilized by ethylene oxide. Single use. Do not re-sterilize. Instrumentation for arthroscopic procedures is available. ARTHROFIX must be used with the corresponding tap supplied by VIMS. For any further information, please refer to the IFU. DESIGNATION ARTHROFIX Ø 5.5 ANCHOR CLASSE I NOT STERILE / INSTRUMENTATION *Datas provided...

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BROCHURE - ARTHROFIX

BROCHURE - ARTHROFIX

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