Device Dossier

HEALICOIL REGENESORB Suture Anchors with two/three MINITAPE Sutures - Fixation anchor, soft-tissue, biodegradable

Device Dossier for HEALICOIL REGENESORB Suture Anchors with two/three MINITAPE Sutures - Fixation anchor, soft-tissue, biodegradable (Fixation anchor,…

Intended purpose

HEALICOIL REGENESORB Suture Anchors with MINITAPE are indicated for use only for the reattachment of soft tissue to bone for the following indications: Shoulder • Rotator cuff tear repairs • Capsular shift or capsulolabral reconstructions • Biceps tenodesis

Functional description

The HEALICOIL REGENESORB Suture Anchors (4.75mm and 5.5mm) with MINITAPE (UHMWPE) are offers including double/triple loaded suture options. The delivery system of the Suture Anchor enables the suture implant to be fixated in the prepared bone tunnel. The sutures are loaded internal to the anchor and delivery device. Upon insertion, the delivery device advances the anchor into the bone hole. The coils on the outside of the suture anchor allow the anchor to fixate within the bone tunnel.

TGA Public Summary