Spacer-S - Cement, orthopaedic, bone spacer

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Compliance Management Solutions

Class:

Class III

Manufactured by:

Tecres SPA Via Andrea Doria 6, Sommacampagna, , Verona, 37066 Italy

Therapeutic area:

33982 - Cement, orthopaedic, bone spacer

Therapeutic indications:

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. 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.

Authorization status:

A

Authorization date:

2022-04-20