Device Dossier

Soft-tissue anchor, non-bioabsorbable

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

Intended purpose

Anchors are indicated for use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, hip and knee. Specific indications are: Shoulder Indications: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair. Wrist/Hand Indications: Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction. Ankle/Foot Indications: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction. Elbow Indications: Ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction Knee Indications: Extra capsular Repair: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis reconstruction, and patellar ligament and tendon repair, vastus medalis obliquus (VMO) muscle advancement. Hip: Capsular repair, acetabular labral repair

TGA Public Summary