đź“‹ FDA Reference
Optium Dbm Gel and Putty
Lifenet
Summary: The Optium DBM Gel and Putty by Lifenet is a bone graft substitute used in orthopedic and spinal surgeries to promote bone growth. It is typically used by orthopedic surgeons and neurosurgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K053098 ↗
Decision Date ?
November 28, 2005
Product Code ?
MBP
Device Class ?
Class 2
Evidence ?
0 studies
The Optium DBM Gel and Putty was cleared via the FDA 510(k) pathway on November 28, 2005. Manufactured by Lifenet, it is classified as a Class II medical device.
What It Is
The Optium DBM Gel and Putty is a demineralized bone matrix (DBM) product used as a bone graft substitute. It is composed of processed human bone tissue that has been demineralized to expose proteins that aid in bone regeneration. The gel and putty forms allow for easy handling and application during surgical procedures. This device is designed to support bone healing and growth by providing a scaffold for new bone formation.
FDA-Cleared Indications
- Use as a bone-graft substitute to support bone healing and bone formation.
- Use in orthopedic and spinal surgical procedures where bone grafting is indicated.
- Use to fill or support repair of bone defects, including defects associated with fusion, reconstruction, or healing problems.
Clinical Applications
- Bone grafting during spinal fusion procedures.
- Filling bone defects during orthopedic reconstruction.
- Adjunctive grafting during fracture repair when bone healing support is needed.
- Use in procedures involving non-union or delayed bone healing when the surgeon determines that a bone-graft substitute is appropriate.
Practical Considerations
- The product is available in gel and putty formulations; the appropriate form and amount depend on the surgical site and defect size.
- It is a human tissue-derived product and must be handled according to the manufacturer’s instructions for sterility, storage, preparation, and application.
- The product is intended for use with standard surgical techniques and instruments; it does not replace stabilization, fixation, or correction of mechanical causes of non-union.
- MRI safety depends on the implanted material and any accompanying hardware used in the procedure. The device labeling and the implant or fixation system’s MRI conditions should be reviewed before scanning.
- Contraindications, precautions, disease-transmission risks, immune reactions, and use in infection or compromised tissue should be reviewed in the current product labeling and surgical plan.
Frequently Asked Questions
What is Optium DBM Gel and Putty used for?
It is used as a bone graft substitute to promote bone growth in orthopedic and spinal surgeries.
What specialties typically use this device?
Orthopedic surgeons and neurosurgeons commonly use this device in surgical procedures.
What are the FDA-cleared indications?
It is indicated for use in bone grafting procedures to support bone growth and healing in conditions like spinal fusions and 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.