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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
510K
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.
Clinical Applications
AlloCraft DBM is frequently used in orthopedic and reconstructive surgeries to promote bone healing in cases such as spinal fusions, bone fractures, and craniofacial reconstructions. It is particularly useful in settings where autologous bone grafts are not feasible or desirable. The device is suitable for a wide range of patient populations, including those with critical-sized bone defects.
Indications for Use
The FDA indications for AlloCraft DBM include its use in bone grafting procedures to promote bone growth and healing. It is intended for patients with bone defects or conditions that require enhanced bone regeneration.
Practical Considerations
AlloCraft DBM is available in various sizes to accommodate different surgical needs. It is compatible with standard surgical techniques used in bone grafting procedures. Clinicians should consider the specific defect size and patient condition when selecting the appropriate product size.
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.