Device Dossier

Truespan Meniscal Repair System PEEK - Fixation anchor, soft-tissue, biodegradable

Device Dossier for Truespan Meniscal Repair System PEEK - Fixation anchor, soft-tissue, biodegradable (Fixation anchor, soft-tissue, biodegradable, Class…

Intended purpose

Truespan Meniscal Repair System PEEK is intended for use in meniscal repairs and meniscal allograft transplant procedures. It is intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures.

Functional description

Consists of a sterile disposable applier preloaded with backstop assembly and needle. The applier introduces the backstop assembly into the meniscus. The backstop assembly is composed of two non-absorbable PEEK backstops, partially absorbable #2-0 violet Orthocord suture and UMHWPE braid. The two backstops are deployed across the fixation point and compression is accomplished by pulling on the suture post.

TGA Public Summary