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The Arthronet BLACKLINE Arthroscopic Blades are indicated for minimally invasive joint surgeries, including but not limited to synovectomie, subacromial decompression, chondroplastic and ACL reconstruction.

The Arthronet BLACKLINE Arthroscopic Blades are manufactured by Arthronet GmbH & Co. KG (formerly Imtec Medinzentechnik). The Blades are limited-use arthroscopic blade components (intended to be used three times, or until they are damaged/dull - whichever occurs first). This product consists of either two or three components. The three-component product has an outer blade assembly, an inner blade, and an inner blade hub adapter. The two component product has an outer blade assembly and an inner blade assembly. The blade sets consist of six hub assembly configurations, and has both straight and curved blade configurations. Each configuration, except for the Arthronet 123 series, is designed to fit a specific FDA Cleared Arthroscopic Shaver System. Arthronet BLACKLINE Arthroscopic Blades are all made from 304 Stainless Steel and the adapter hubs are made from hardened anodized aluminum and stainless steel. These materials are essentially equivalent to those of predicate devices. Configurations and sizes are typical of predicate devices and indicated in catalog labeling. Arthronet BLACKLINE Arthroscopic Blade assemblies consist of 2 piece and 3 piece blade assemblies, depending upon the shaver system they are used with. The 3 Piece blade consists of a single outer blade/hub assembly within which a two-piece inner blade and hub assembly can be inserted. The inner blade assembly snaps into place within the inner blade hub adapter. The resulting inner blade assembly, in turn, snaps into place within the outer blade assembly. The 2 Piece blade consists of a single blade/hub outer and a single inner blade/hub that are joined together in the identical fashion as the 3 Piece. The distal cutting orifices of the inner and outer blade assemblies align precisely to allow for rotary cutting as the inner blade rotates within the fixed outer blade. These assemblies are designed to facilitate cleaning and autoclave sterilization. Autoclave sterilization parameters are equivalent to predicate products noted and directions for use, cleaning and sterilization are contained in product labeling. Arthronet BLACKLINE Arthroscopic Blades are provided in a Non-Sterile condition. Recommended disassembly, cleaning, reassembly and sterilization instructions are identified and included in product labeling. These products are intended to be steam pressure autoclaved at cycle parameters equal to or exceeding 132 degrees C and 2bar pressure for 5 minutes. Cautionary warnings alert the user to thoroughly clean the units prior to sterilization and to remove all debris during the cleaning process. Cleaning and sterilization criteria are recommendations only and are based upon simulated use testing on file with the manufacturer. Labeling clearly indicate that hospitals should use their own validated cleaning and sterilization processes for these types of products. Arthronet BLACKLINE Arthroscopic Blades are limited use devices. Blades are clearly labeled for use a maximum of three (3) uses. The blade assemblies can be discarded after three uses. Product usage and cautions related to potential damage to the blade assemblies as a result of handling or cleaning are clearly defined in product labeling. All product usage is based upon design data developed during product design, simulated use verification testing, and is also based upon seven years of clinical product experience in the worldwide market.