Device Dossier

Spacer-S - Cement, orthopaedic, bone spacer

Device Dossier for Spacer-S - Cement, orthopaedic, bone spacer (Cement, orthopaedic, bone spacer, Class III, sponsor Compliance Management Solutions).…

Intended purpose

Spacer-S is indicated for temporary use (maximum 180 days) as an adjunct to total shoulder replacement and hemi-shoulder replacement procedures in skeletally mature patients undergoing a two-stage revision procedure due to a septic process.

Functional description

A device temporarily placed into the shoulder joint space to prevent bone on bone contact and contraction of soft tissue during the treatment of an infected joint. The device locally releases gentamicin to help the treatment of the infection. The Spacer-S comes in 2 sizes.

TGA Public Summary