Device Dossier

ASLS Sleeves - Fixation device, internal, nut

Device Dossier for ASLS Sleeves - Fixation device, internal, nut (Fixation device, internal, nut, Class III, sponsor DePuy Synthes). ARTG record,…

Intended purpose

ASLS is used as an alternative to standard locking of cannulated Synthes Titanium IM Nails, for the operative treatment and stabilization of fractures in the tibia, according to the specific indications listed in the labelling of the corresponding nail system. ASLS is particularly indicated in cases where increased stability is needed, for example in fractures closer to the metaphyseal area or in osteopenic bone.

Functional description

ASLS sleeves are made with 70:30 poly(Llactide-co-D,L-lactide) which breaks down to lactic acid which the body metabolizes to H20 and CO2. Stability is retained for 12 weeks with full degradation taking about 2 years. When the ASLS screw and sleeve is inserted into the nail locking hole, the sleeve expands and the gap between ASLS Screw and nail locking hole is filled completely and thus prevents the screw from toggling, providing angular stability to the nail-screw construct.

TGA Public Summary