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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 104215
In Commercial Distribution
- 08058964726049 ()
- Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
433180
In Commercial Distribution
- 00887868543302 ()
- M/L 80mm A/P 48mm
433180
- Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
433175
In Commercial Distribution
- 00887868543296 ()
- M/L 75mm A/P 45mm
433175
- Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
433170
In Commercial Distribution
- 00887868543289 ()
- M/L 70mm A/P 42mm
433170
- Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
432175
In Commercial Distribution
- 00887868543265 ()
- M/L 75mm A/P 57mm
432175
- Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
432165
In Commercial Distribution
- 00887868543241 ()
- M/L 65mm A/P 48mm
432165
- Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
431414
In Commercial Distribution
- 00887868543227 ()
- Ø14mm Stem Ø64mm Head 58mm Head Width 24mm Head Thickness
431414
- Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
431410
In Commercial Distribution
- 00887868543203 ()
- Ø10mm Stem Ø57mm Head 50mm Head Width 21mm Head Thickness
431410
- Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
431408
In Commercial Distribution
- 00887868543197 ()
- Ø8mm Stem Ø53mm Head 46mm Head Width 18mm Head Thickness
431408
- Orthopaedic cement spacer mould
No Description
Biomet Orthopedics, LLC
431406
In Commercial Distribution
- 00887868543180 ()
- Ø6mm Stem Ø46mm Head 42mm Head Width 18mm Head Thickness
431406
- Orthopaedic cement spacer mould