📋 FDA Reference
Allocraft Dbm
Lifecell
Summary: AlloCraft DBM is a demineralized bone matrix used for bone regeneration. It is commonly used by orthopedic and reconstructive surgeons for patients requiring bone grafting.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K052735 ↗
Decision Date ?
December 28, 2005
Product Code ?
MBP
Device Class ?
Class 2
Evidence ?
0 studies
AlloCraft DBM was cleared through the FDA 510k pathway on December 28, 2005. It is manufactured by Lifecell and classified as a Class 2 medical device.
What It Is
AlloCraft DBM is a demineralized bone matrix product designed to aid in bone regeneration. It works by providing a scaffold that supports the growth of new bone tissue. The device is composed of demineralized bone and an acellular matrix, which helps facilitate the integration and healing of bone defects.
FDA-Cleared Indications
- Use as a bone-grafting material to promote bone growth and healing in bone defects.
- Use in surgical procedures that require a demineralized bone matrix or bone allograft material.
Clinical Applications
- Filling or supporting bone defects during orthopedic surgery
- Use as an adjunct to bone-grafting procedures when additional graft material is needed
- Supporting bone healing in reconstructive procedures involving bone defects
Practical Considerations
- The available product size and form should match the defect size and the surgical technique.
- AlloCraft DBM is intended for use by trained clinicians with standard bone-grafting techniques.
- Patient evaluation should include the location and size of the defect, bone quality, infection risk, and the need for additional fixation or graft material.
- MRI safety information depends on the specific packaged product and any accompanying components; clinicians should review the current product labeling before MRI.
- Contraindications, handling, storage, and preparation requirements should be followed as specified in the current manufacturer labeling.
Related Literature
The linked study evaluated the bone-regenerative potential of the AlloCraft DBM composite in a rat model with critical-sized calvarial defects. The study found that the DBM/AM composite had a higher percentage of defect fill compared to controls, indicating its effectiveness in promoting bone regeneration. However, the study was limited to an animal model, and further research in human subjects is needed to confirm these findings.
Frequently Asked Questions
What is AlloCraft DBM used for?
AlloCraft DBM is used for bone regeneration in procedures such as spinal fusions and craniofacial reconstructions.
What specialties typically use this device?
Orthopedic and reconstructive surgeons commonly use AlloCraft DBM.
What are the FDA-cleared indications?
AlloCraft DBM is indicated for use in bone grafting procedures to promote bone growth and healing in patients with bone defects.
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.