Donated tissue processed into DBX Demineralized Bone Matrix must pass MTF’s extensive donor screening criteria which exceed standards set by the FDA and AATB. After acceptable donors are identified, the tissue is then evaluated for bioburden utilizing MTF’s Vanguard Method™ tissue assessment, a validated qualitative and quantitative analysis that is more comprehensive than the industry standard.3
The tissue is processed using aseptic techniques in ISO class 4 (certified) clean rooms to maintain biological integrity. Each finished lot of DBX Demineralized Bone Matrix is tested in a validated in vivo or in vitro model and must score positive for osteoinductive potential prior to release for clinical use.
MTF’s approach to tissue transplantation provides clinicians confidence in their tissue selection and patients peace of mind of the gift they received.
Key Features & Benefits
- Available in various forms (i.e., putty, mix, strip)
- High bone content with biocompatible carrier providing desired handling characteristics
- Osteoinductive potential verified on each finished lot of tissue prior to release for clinical use to confirm biological integrity of tissue
- Extensive donor screening criteria exceeding standards set by the FDA and AATB providing safe tissue for transplantation
- Comprehensive bioburden testing and aseptic processing preserves biological integrity of tissue
DBX Mix, DBX Putty, and DBX Inject are intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. DBX is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury.
DBX Putty can be used alone in the posterolateral spine. DBX Putty can also be used as an extender in the spine with autograft or allograft. DBX Putty can be used with bone marrow. DBX Putty is for single patient use only.
* Please refer to the package insert for a complete list of indications, contraindications, warnings and precautions.
For further information on MTF tissues, please contact your local
DePuy Synthes Spine representative.