đź“‹ FDA Reference
Sygnal Dbm
Musculoskeletal Transplant Foundation
Summary: Sygnal DBM is a demineralized bone matrix used in orthopedic procedures to aid in bone healing and regeneration. It is typically used by orthopedic surgeons and other specialists in musculoskeletal care.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K080405 ↗
Decision Date ?
August 28, 2008
Product Code ?
MBP
Device Class ?
Class 2
Evidence ?
0 studies
The Sygnal DBM was cleared via the FDA 510k pathway on August 28, 2008, by the Musculoskeletal Transplant Foundation. It is classified as a Class 2 device under product code MBP.
What It Is
The Sygnal DBM is a demineralized bone matrix product designed to support bone healing and regeneration. It is composed of processed human bone tissue, which has been treated to remove minerals, leaving behind a collagen matrix that can stimulate new bone growth. This device is particularly useful in orthopedic and spinal surgeries where bone grafting is necessary.
FDA-Cleared Indications
- Use as a bone graft substitute to aid bone regeneration during orthopedic surgery.
- Use when bone graft material is needed to support healing in procedures involving bone repair or fusion.
Clinical Applications
- Bone grafting during spinal fusion procedures.
- Support of bone healing after fracture repair.
- Use during orthopedic reconstruction procedures when graft material is needed.
- Use with standard orthopedic implants and surgical techniques when additional graft material is indicated.
Practical Considerations
- Sygnal DBM is available in different forms and sizes; the surgeon selects the format appropriate for the defect and procedure.
- It may be used with other bone graft materials or orthopedic implants when clinically appropriate.
- Because it is derived from processed human bone tissue, it must be handled, stored and prepared according to the manufacturer’s instructions and tissue-bank requirements.
- MRI safety depends on any accompanying implant or delivery system; the DBM material itself is not typically the component that creates an MRI hazard, but the complete implanted construct should be evaluated.
- Contraindications and precautions may include infection at the surgical site, inadequate soft-tissue coverage, or patient factors that impair bone healing. The product labeling and surgeon’s assessment should guide use.
Frequently Asked Questions
What is Sygnal DBM used for?
Sygnal DBM is used as a bone graft substitute to promote bone healing and regeneration in orthopedic surgeries.
What specialties typically use this device?
Orthopedic surgeons and spine specialists commonly use this device in procedures requiring bone grafting.
What are the FDA-cleared indications?
Sygnal DBM is indicated for use as a bone graft substitute to aid in bone regeneration during orthopedic 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.