Device Dossier

Soft-tissue anchor, non-bioabsorbable

Device Dossier for Soft-tissue anchor, non-bioabsorbable (Soft-tissue anchor, non-bioabsorbable, Class IIb, sponsor Compliance Management Solutions).…

Intended purpose

These devices are intended to reattach soft tissue to bone in orthopaedic surgical procedures in Shoulder, knee, wrist/hand, ankle/foot, elbow and hip. These devices may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization throughout the healing period.

TGA Public Summary