Device Dossier

HEALICOIL REGENESORB Suture Anchor with ONE ULTRATAPE and ONE ULTRABRAID Suture - Fixation anchor, soft-tissue, biodegradable

Device Dossier for HEALICOIL REGENESORB Suture Anchor with ONE ULTRATAPE and ONE ULTRABRAID Suture - Fixation anchor, soft-tissue, biodegradable…

Intended purpose

A device intended 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

An absorbable biocomposite suture anchor with attached nonabsorbable ULTRATAPE and ULTRABRAID sutures. The anchor has a double lead thread which extends to the distal end to enable a screw-in insertion technique into a pre-drilled hole and it is fully cannulated to take one strand each of ULTRATAPE suture and ULTRABRAID suture. The sutures are braided, uncoated, UHMWPE and/or UHMWPE with monofilament nylon cobraid pre-assembled on a disposable stainless-steel inserter shaft and ABS Handle.

TGA Public Summary