StemVie™ Resorbable Synthetic Bone Graft is intended for use as a bone void filler for bony voids or gaps of the skeletal system (e.g. extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. StemVie™ Graft can be used with autograft as a bone graft extender.StemVie™Graft is a bone filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended.
When packed into a bony site, StemVie™Graft gradually resorbs and is replaced with bone during the healing process. In addition, when used with appropriate opening osteotomy system devices,plates and screws, StemVie™Graft is intended to be used as a bone void filler in femoral or tibial osteotomies. StemVie™Graft is to be used in association with adequate post-operative immobilization.
StemVie™ Graft may be used with physiological saline, patient's own serum, whole blood, or bone marrow aspirate (BMA).
StemVie™ has limited initial mechanical properties. Therefore, this product is contraindicated where the device is intended as structural support in the skeletal system. Conditions representing contraindications include also:
For additional information regarding Instructions for
Use, Adverse Effects, Warnings, and Precautions,
see Package Insert accompanying product.