Device Dossier
Spacer-G Flat Stem - Cement, orthopaedic, bone spacer
Device Dossier for Spacer-G Flat Stem - Cement, orthopaedic, bone spacer (Cement, orthopaedic, bone spacer, Class III, sponsor Compliance Management…
- GMDN category: Cement, orthopaedic, bone spacer
Intended purpose
Spacer-G Flat Stem is indicated for temporary use (maximum 180 days) in total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process.
Functional description
A device temporarily placed into the hip 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-G Flat Stem comes in 6 sizes.