Device Dossier
HEALICOIL REGENESORB Suture Anchor with Two/Three ULTRABRAID Sutures - Fixation anchor, soft-tissue, biodegradable
Device Dossier for HEALICOIL REGENESORB Suture Anchor with Two/Three ULTRABRAID Sutures - Fixation anchor, soft-tissue, biodegradable (Fixation anchor,…
- GMDN category: Fixation anchor, soft-tissue, biodegradable
- Sponsor: Smith & Nephew
Intended purpose
HEALICOIL REGENESORB Suture Anchors are 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
The anchor has a double-lead thread that extends close to the distal end of the anchor to enable a screw-in insertion technique. The anchor is fully cannulated & takes upto 3 strands of nonabsorbable ULTRABRAID suture. Anchor is preassembled onto a stainless-steel inserter & preloaded with suture anchor construct. The anchor is bioabsorbable with 2 strands of uncoated UHMW polyethylene suture(Blue/Cobraid Blue) and/or 1 strand of UHMW polyethylene suture with monofilament nylon(Cobraid Black)