RevMed

TECRES SPA SPK0322 InterSpace Knee

Company Name
TECRES SPA
Catalog Number
SPK0322
Device Size
  • tibial component width 90 mm
  • femoral component width 74 mm

Description

Temporary knee spacer with gentamicin. InterSpace Knee is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement.The device is sterile and single-use.InterSpace Knee is indicated for temporary use (maximum 180 days) as a total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process.InterSpace Knee is applied on the femoral condyles and on the tibial plate following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).InterSpace Knee is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.). Because of the inherent mechanical limitations of the device material (gentamicin/polymethylmethacrylate), Interspace Knee is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.
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Additional Details

Device Identifier
28031497001160
Is RX
Yes
Is Over the Counter
No
Requires Sterilization
No
Is Sterile
Yes
Is Single Use
Yes

Barcode Mapping

Unit of MeasurementEachesGTIN
Each128031497001160