Device Dossier

Soft-tissue anchor, non-bioabsorbable

Device Dossier for Soft-tissue anchor, non-bioabsorbable (Soft-tissue anchor, non-bioabsorbable, Class IIb, sponsor Wiselink Group). ARTG record,…

Intended purpose

These devices are intended for the fixation of soft tissue or soft tissue grafts to bone in orthopaedic surgical procedures in the Shoulder, knee, wrist/hand, ankle/foot and elbow. These devices offer a variety of designs for selection, such as Titanium Suture Anchor, Titanium Suture Anchor with Needles, PEEK Suture Anchor, All-Suture Anchor, FixButton and Interference Screw. These devices are mainly made of materials such as Ultra-high molecular weight polyethylene (UHMWPE), titanium (TC4), and PolyEtherEtherKetone (PEEK).

TGA Public Summary