đź“Š Evidence-Based Reference
Dbx-H Hemostatic Demineralized Bone Matrix Putty
Orthocon
Summary: The dbx-h hemostatic demineralized bone matrix putty is a medical device used primarily for bone regeneration and repair. Key evidence highlights its application in enhancing bone healing and integration.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K061131 ↗
Decision Date ?
February 8, 2007
Product Code ?
MBP
Device Class ?
Class 2
Evidence ?
0 studies
The dbx-h hemostatic demineralized bone matrix putty was cleared via the FDA 510(k) pathway on February 8, 2007. It is manufactured by Orthocon and classified as a Class 2 device.
What It Is
The dbx-h putty is a demineralized bone matrix designed to promote bone healing and regeneration. It is used in clinical settings to support bone repair by providing a scaffold that facilitates the release of growth factors.
FDA-Cleared Indications
- Use as a bone-graft substitute or adjunct to fill bone voids or defects that are not intrinsic to the stability of the bony structure.
- Use in orthopedic and reconstructive procedures where bone graft material is needed to support bone repair and regeneration.
- Use in conjunction with standard methods of bone fixation and stabilization when clinically indicated.
Clinical Applications
- Filling contained bone defects during orthopedic surgery
- Supporting bone healing in reconstructive procedures
- Use as an adjunct during repair of bone defects associated with tendon or ligament procedures
- Placement with other fixation or grafting methods when additional bone-graft material is required
Evidence Summary
The literature includes 10 studies, comprising various study types such as RCTs and case series, conducted between 2016 and 2025. These studies explore the efficacy and safety of the dbx-h putty in different clinical contexts.
Reported Outcomes
Published studies report that the dbx-h putty effectively supports bone regeneration and healing, particularly in critical-size defects and cartilage repair. It has been shown to enhance tendon-bone healing in rotator cuff repairs and facilitate cartilage repair in animal models.
Safety Profile
Reported complications include potential for weak scar tissue formation in tendon-bone healing and variability in bone regeneration outcomes. However, no severe adverse events were consistently reported across studies.
Evidence Limitations
The evidence is limited by small sample sizes and variability in study design. Further research is needed to establish long-term outcomes and to compare the dbx-h putty with alternative bone graft materials.
Practical Considerations
- The putty should be handled according to the manufacturer’s instructions and placed into a prepared bone defect using sterile technique.
- It is not intended to provide structural support by itself; defects requiring mechanical stability generally need fixation or another structural graft.
- Patient selection should consider infection, poor soft-tissue coverage, inadequate blood supply, metabolic bone disease, and other factors that may impair healing.
- MRI safety and artifact information should be confirmed in the current product labeling; a specific MRI designation should not be assumed without that documentation.
- The product is a biologic graft material rather than a permanent metallic implant, and its remodeling depends on the patient’s biology, defect, fixation, and local blood supply.
Frequently Asked Questions
What are the clinical indications for dbx-h hemostatic demineralized bone matrix putty?
The dbx-h putty is indicated for use in bone regeneration and repair, particularly in orthopedic surgeries and procedures requiring enhanced bone healing.
What outcomes have been reported in clinical studies?
Studies have reported successful bone regeneration and healing, improved tendon-bone integration in rotator cuff repairs, and effective cartilage repair in animal models.
What complications have been reported?
Reported complications include the potential for weak scar tissue formation and variability in bone regeneration outcomes, with no severe adverse events consistently noted.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.