Search Results

The X-Twist Biocomposite Suture Anchors are indicated for attachment of soft tissue to bone. These products are intended for the following indications:

Shoulder: Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromo-Clavicular Separation Repair, Deltoid Repair

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair, Meniscal Root Repair, Secondary or adjunct fixation for ACL/PCL reconstruction or repair, MPFL Repair/Reconstruction

Elbow: Ulnar/Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair

The X-Twist Biocomposite Suture Anchor consists of the implants (anchor and anchor tip) and the anchor driver assembly. The anchor and anchor tip are provided assembled to the driver and sterile. The X-Twist Biocomposite anchor is molded using a composite of beta-TCP (beta-tricalcium-phosphate) and PLGA (poly-lactic-co-glycolic acid). The anchor tip is molded using PEEK (polyetheretherketone). The anchor is fully threaded, double-helical, cannulated, and has inline fenestrations on each quarter-turn face. The anchor tip is retained on the driver via retention suture(s) or suture tape(s) that are passed through the driver cannulation, looped over the retention bridge within the tip, and returned out the proximal end of the driver handle and cleated. These devices are to be used with a drill, awl, and/or bone tap. The X-Twist Biocomposite Suture Anchors are provided sterile and in 4.75mm, 5.5mm, or 6.25mm diameters.

The X-Twist Biocomposite Suture Anchor, as described in this 510(k) summary, did not undergo a study to prove acceptance criteria in the traditional sense of a clinical or standalone performance study. Instead, the FDA determined substantial equivalence based on non-clinical testing and comparison to predicate devices.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For the specific non-clinical test reported, here are the acceptance criteria and results:

Ask a specific question about this device