đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use as a bone graft substitute to promote bone healing in orthopedic and spinal surgery.
- Use in procedures requiring bone regeneration or healing of skeletal defects.
Clinical Applications
- Bone grafting during spinal fusion procedures.
- Treatment of bone defects associated with orthopedic surgery.
- Support of bone healing in selected fracture-repair procedures.
- Use when a surgeon determines that a bone graft substitute is needed instead of, or in addition to, available autograft bone.
Practical Considerations
- The product may be supplied in forms such as putty or strips; the surgeon selects the form and amount based on the defect and operative technique.
- It is intended for use by trained surgical professionals with standard orthopedic or spinal bone-grafting techniques.
- The surgical team should review the product labeling for tissue-screening requirements, handling, storage, contraindications and precautions before use.
- MRI safety depends on the final implanted material and any associated hardware. The patient should provide the implant record to the MRI facility before imaging.
- As with other human tissue-derived graft products, risks may include infection, inflammatory or immune reactions, inadequate bone healing and the need for additional surgery.
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.