Device Dossier

Suture Anchor, SwiveLock Tenodesis, Biocomposite, Forked Tip PEEK Eyelet - Fixation anchor, soft-tissue, biodegradable

Device Dossier for Suture Anchor, SwiveLock Tenodesis, Biocomposite, Forked Tip PEEK Eyelet - Fixation anchor, soft-tissue, biodegradable (Fixation…

Intended purpose

The bioabsorbable fixation anchors are intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder and hip.

Functional description

The device is comprised of two sections, an absorbable anchor body of PLLA and ßTCP and a non-absorbable forked tip PEEK eyelet. The suture anchor is pre-mounted on a driver with the anchor body and eyelet physically separated on the driver shaft. Strong fixation is obtained by screwing the anchor body into the socket.

TGA Public Summary