Device Dossier

Knotilus+ Biocomposite Knotless Anchor - Fixation anchor, soft-tissue, biodegradable

Device Dossier for Knotilus+ Biocomposite Knotless Anchor - Fixation anchor, soft-tissue, biodegradable (Fixation anchor, soft-tissue, biodegradable,…

Intended purpose

The Knotilus+ Biocomposite Knotless Anchors are intended to be used for soft-tissue to bone fixation in skeletally mature pediatric and adult patients in the shoulder, foot and ankle, knee, hand and wrist, elbow, and hip. 3911-824-511 (2.4x11.3mm), 3911-829-512 (2.9x12.5mm), 3911-829-412 (2.9x12.5mm) and 3911-829-515 (2.9x15.5mm) - Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Capsular Shift or Capsulolabral Reconstruction - Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair - Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair and Posterior Oblique Ligament Repair - Hand and Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction - Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair - Hip: Acetabular Labral Repair 3911-824-408 (2.4x8.9mm) - Hip: Acetabular Labral Repair

Functional description

The Knotilus+ Biocomposite Knotless Anchor is a set of hard-body, push-in, knotless implants to be used as soft-tissue fixation devices. These implants include two types: the Eyelet, which is responsible for delivering suture below the cortical layer of bone, and the Anchors, which are responsible for the System's fixation to bone. Both the Eyelet and the Anchors are packaged assembled onto a disposable, stainless steel, size-specific inserter.

TGA Public Summary