Device Dossier

BioComposite SwiveLock - Fixation anchor, soft-tissue, biodegradable

Device Dossier for BioComposite SwiveLock - Fixation anchor, soft-tissue, biodegradable (Fixation anchor, soft-tissue, biodegradable, Class III, sponsor…

Intended purpose

The BioComposite SwiveLock suture 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

BioComposite SwiveLock anchors are comprised of absorbable PLA and TCP and are provided with a non-absorbable eyelet. It is a twist-in knotless device, consisting of an eyelet and anchor body that are pre-mounted and physically separated on a driver shaft. It is designed to provide necessary pull-out strength during the healing period.

TGA Public Summary