Device Dossier

ComposiTCP® 60 resorbable interference screw - Fixation screw, bone, biodegradable

Device Dossier for ComposiTCP® 60 resorbable interference screw - Fixation screw, bone, biodegradable (Fixation screw, bone, biodegradable, Class III,…

Intended purpose

ComposiTCP™ is a cannulated, sterile, single-use, resorbable interference bone screw made of a mixture of tri-calcium phosphate (beta-TCP) and PolyLactic DL Acid (PLDL) copolymer designed for the interference fixation of grafts in anterior cruciate ligament reconstruction. ComposiTCP™ 60 is designed for the fixation by interference of only transplants made out of pure ligament.

Functional description

The ComposiTCP® 60 resorbable interference screw is manufactured by injection molding and is composed of DUOSORB 60% β-Tricalcium Phosphate and 40% PolyLactic DL Acid (PLDL). The screws are cannulated and are available in different sizes. The screws have a specific head (Flat or Round), which allows for a more even distribution of the torsional stresses.

TGA Public Summary