Device Dossier

Tendon Anchors with Cartridge-Product Code 72205201 - Fixation staple, tissue, biodegradable

Device Dossier for Tendon Anchors with Cartridge-Product Code 72205201 - Fixation staple, tissue, biodegradable (Fixation staple, tissue, biodegradable,…

Intended purpose

The Tendon Anchor is a medical device intended for fixation of prosthetic material to soft tissues. Tendon Anchors are indicated for fixation of prosthetic material to soft tissues in various minimally invasive and open rotator cuff tendon surgical procedures, such as the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Functional description

Tendon Anchors are bioabsorbable implant devices that provide fixation of a prosthetic material to soft tissue. The Tendon Anchors are provided sterile for single-use only, and are packaged in a cartridge, for use with the manual Tendon Anchor Inserter, in a dual sterile seal, dual pouch configuration. Made from Polylactide and designed to completely absorb within approximately 12 months.

TGA Public Summary