Device Dossier
REGENETEN Bioinductive Implant with Arthroscopic Delivery System - Multi-purpose surgical mesh, collagen
Device Dossier for REGENETEN Bioinductive Implant with Arthroscopic Delivery System - Multi-purpose surgical mesh, collagen (Multi-purpose surgical mesh,…
- GMDN category: Multi-purpose surgical mesh, collagen
- Sponsor: Smith & Nephew
Intended purpose
The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue.
Functional description
The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. The REGENETEN Bioinductive Implant is provided sterile, non-pyrogenic, for single-use only, in a variety of sizes, in a dual sterile seal.