Intended Use Statement (CE): Biomold Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Biomold Putty is indicated to be gently packed into bony voids or gaps of the skeletal system as a bone void filler in the extremities and pelvis, and as a bone graft extender in the posterolateral spine. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Biomold Putty can be used as bone graft
replacement in the long bones and pelvis.
The moldable consistency of the Putty allows
it to be custom fit to the implant site. Once the defect is completely filled, the putty matches the bone void geometry.
Due to its firmness, the Putty can either be manually implanted, or inserted with forceps or other surgical instruments.
When mixed with autograft, Biomold Putty can be used as a bone graft extender in the posterolateral spine.
The Putty is specially designed to maintain its handling following mixing with autograft.
Following hardware placement, it can be isnerted with forceps and placed at the implant site
Biomold Putty can be shaped to conform to the bony anatomy and provides a custom fit around stabilization hardware.
*Images show Biomold Putty prior to combination with autograft. Biomold Putty must be mixed with autograft prior to use in the posterolateral spine.