DBX® Demineralized Bone Matrix

DBX® ​Demineralized Bone Matrix (DBM) is an allograft bone void filler processed by the Musculoskeletal Transplant Foundation (MTF) from donated human tissue. DePuy Synthes Spine has partnered with MTF since 1998 to provide safe tissue for clinicians and their patients.

DBX Demineralized Bone Matrix is an osteoconductive bone graft substitute with osteoinductive potential1 that provides a scaffold which induces new bone formation.2 The osteoinductive potential is produced by removing the minerals from bone, exposing the naturally occurring bone morphogenic proteins (BMPs). The demineralized bone is then combined with a biocompatible carrier formulated to meet the needs of surgeons while maximizing the amount of bone delivered to the surgical site.



Tissue Processing

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

Spine Indications*

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
.




1It is unknown how the osteoinductive potential, measured in the athymic mouse model or the alkaline phosphatase assay, will correlate with clinical performance in human subjects.
2Data on file at the Musculoskeletal Transplant Foundation.
3Mroz, T. E., M. J. Joyce, et al. (2008). "Musculoskeletal allograft risks and recalls in the United States." J Am Acad Orthop Surg 16(10): 559-565.

DBX is a registered trademark of the Musculoskeletal Transplant Foundation.

 

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