Figure 1: Internal depth gauge allows
surgeon to customize thickness of tibial spacer.
Figure 2: Articulating spacer
supports patient range of motion.
Description/Indications
The disposable cement spacer molds (femoral and
tibial) are sterile disposables made of medical grade
silicone. They are intended to be filled with PALACOS
®
R+G Bone Cement* or Refobacin
®
Bone Cement R*,
either by injecting with a dispenser/gun, or by pouring
the prepared cement into the mold. After the cement
cures, the temporary spacers are to be removed from
the molds and placed into the joint space. The spacers
remain in place (180 days or less) until the second
stage of the two-stage procedure is performed to
implant a conventional knee joint prosthesis.
Disposable cement spacer molds are indicated for
use to mold a temporary total knee replacement
(TKR) for skeletally mature patients undergoing a
two-stage procedure due to a septic process. The
molded temporary knee prosthesis is indicated for
an implantation period of 180 days or less. Because
of inherent mechanical limitations of the device
material (PALACOS R+G Bone Cement and Refobacin
Bone Cement R*), the molded temporary prosthesis
is only indicated for patients who will consistently
use traditional mobility assist devices (e.g. crutches,
walkers) throughout the implant period.