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sygnal dbm
Musculoskeletal Transplant Foundation
Summary: Sygnal DBM is a demineralized bone matrix used in orthopedic and spinal surgeries to promote bone healing. It is typically used by orthopedic surgeons and neurosurgeons.
FDA Clearance Information
Pathway
510K
Number
K073329 ↗
Decision Date
February 28, 2008
Product Code
MBP
Device Class
Class 2
Evidence
0 studies
Sygnal DBM was cleared through the FDA 510(k) pathway on February 28, 2008. It is manufactured by the Musculoskeletal Transplant Foundation and classified as a Class 2 medical device.
What It Is
Sygnal DBM is a demineralized bone matrix product designed to aid in bone regeneration and healing. It is derived from human bone tissue that has been processed to remove minerals, leaving behind proteins and growth factors that support bone growth. This product is typically used as a bone graft substitute in various orthopedic and spinal procedures.
Clinical Applications
Sygnal DBM is commonly used in orthopedic surgeries, such as spinal fusions, fracture repairs, and joint reconstructions, where bone grafting is necessary. It is particularly useful in cases where autograft bone is not available or sufficient. The device is used in hospital and surgical center settings, primarily by orthopedic surgeons and neurosurgeons treating patients with bone defects or degenerative conditions.
Indications for Use
The FDA indications for Sygnal DBM include its use as a bone graft substitute to promote bone healing in orthopedic and spinal surgeries. It is suitable for patients requiring bone regeneration due to fractures, spinal fusions, or other skeletal defects.
Practical Considerations
Sygnal DBM is available in various forms, such as putty or strips, to accommodate different surgical needs. It is compatible with standard surgical techniques and instruments. Surgeons should consider the size and shape of the defect when selecting the appropriate form of the product.
Frequently Asked Questions
What is Sygnal DBM used for?
Sygnal DBM is used to promote bone healing in orthopedic and spinal surgeries, serving as a bone graft substitute.
What specialties typically use this device?
Orthopedic surgeons and neurosurgeons typically use Sygnal DBM in surgical procedures requiring bone regeneration.
What are the FDA-cleared indications?
Sygnal DBM is indicated for use as a bone graft substitute to aid in bone healing in orthopedic and spinal surgeries.
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.