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Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a
temporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stage
revision procedure due to a septic process.
The temporary prosthesis is molded using low viscosity polymethylmethacrylate bone
cement and inserted into the humeral medullary canal and glenoid cavity of the shoulder
following removal of the existing humeral and glenoideal cavity implants and debridement.
SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.
The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy
(standard treatment approach to an infection).
The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds is
not intended for use more than 180 days, at which time it must be explanted and permanent
devices implanted or another appropriate treatment performed (e.g. resection arthroplasty,
fusion, etc.).
Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (low
viscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicated
for patients who will consistently follow activity limitation throughout the implant period.
The device can exclusively be used by competent healthcare personnel who has complete
scientific and anatomical knowledge.
G21 SRL
900001 084215
In Commercial Distribution
- 08058964724977 ()
- Orthopaedic cement spacer mould
TIBIAL SPACER MOLD LARGE
Ortho Development Corporation
SST2081
In Commercial Distribution
- 00822409043231 ()
- Length: 52 Millimeter
- Width: 81 Millimeter
- Orthopaedic cement spacer mould
TIBIAL SPACER MOLD MEDIUM
Ortho Development Corporation
SST2070
In Commercial Distribution
- 00822409043224 ()
- Width: 70 Millimeter
- Length: 45 Millimeter
- Orthopaedic cement spacer mould
TIBIAL SPACER MOLD SMALL
Ortho Development Corporation
SST2058
In Commercial Distribution
- 00822409043217 ()
- Width: 58 Millimeter
- Length: 39 Millimeter
- Orthopaedic cement spacer mould
FEMORAL SPACER MOLD LARGE
Ortho Development Corporation
SSF1075
In Commercial Distribution
- 00822409043200 ()
- Width: 75 Millimeter
- Length: 53 Millimeter
- Orthopaedic cement spacer mould
FEMORAL SPACER MOLD MEDIUM
Ortho Development Corporation
SSF1067
In Commercial Distribution
- 00822409043194 ()
- Length: 44 Millimeter
- Width: 67 Millimeter
- Orthopaedic cement spacer mould
FEMORAL SPACER MOLD SMALL
Ortho Development Corporation
SSF1060
In Commercial Distribution
- 00822409043187 ()
- Width: 60 Millimeter
- Length: 37 Millimeter
- Orthopaedic cement spacer mould
Large 52A/P x 81M/L Tibial Spacer Mold
Ortho Development Corporation
669-2081
In Commercial Distribution
- 00822409007608 ()
- Length: 52 Millimeter
- Width: 81 Millimeter
- Orthopaedic cement spacer mould
Small 39A/P x 58M/L Tibial Spacer Mold
Ortho Development Corporation
669-2058
In Commercial Distribution
- 00822409007585 ()
- Width: 58 Millimeter
- Length: 39 Millimeter
- Orthopaedic cement spacer mould
Medium 44A/P x 67M/L Femoral Spacer Mold
Ortho Development Corporation
669-1067
In Commercial Distribution
- 00822409007561 ()
- Width: 67 Millimeter
- Length: 44 Millimeter
- Orthopaedic cement spacer mould