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Progenix Dbm Putty and Paste
Summary: Progenix DBM Putty and Paste 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 ?
K060794 ↗
Decision Date ?
December 18, 2006
Product Code ?
MBP
Device Class ?
Class 2
Evidence ?
0 studies
Progenix DBM Putty and Paste was cleared through the FDA 510(k) pathway on December 18, 2006. It is manufactured by Medtronic Sofamor Danek and classified as a Class II medical device.
What It Is
Progenix DBM Putty and Paste is a demineralized bone matrix (DBM) product used as a bone graft substitute. It is designed to facilitate bone growth and healing by providing a scaffold that supports the proliferation of osteogenic cells. The putty and paste formulations allow for easy handling and application during surgical procedures.
FDA-Cleared Indications
- Use as a bone-graft substitute in orthopedic and spinal surgical procedures where bone formation is needed.
- Use to support bone healing and fusion by providing a scaffold for bone growth.
Clinical Applications
- Adjunctive bone grafting during spinal fusion procedures.
- Filling or supporting bone defects created during orthopedic surgery.
- Use in selected fracture-repair procedures that require a bone-graft substitute.
- Placement into a prepared surgical site to support bone regeneration.
Practical Considerations
- The putty and paste formulations are available in different package sizes and are selected according to the surgical defect and planned procedure.
- The material is intended for use with standard sterile surgical techniques and should be handled according to the manufacturer’s instructions.
- The surgeon prepares the bone defect and places the material directly at the intended graft site; it is not a vascular or injectable device.
- MRI safety information depends on the final implanted construct, including any hardware used during surgery. The product labeling and the MRI conditions for associated implants should be reviewed before scanning.
- Contraindications, warnings and precautions include reviewing the labeling for allergy or sensitivity concerns, infection at the operative site, inadequate bone quality or blood supply, and other factors that could impair healing.
Frequently Asked Questions
What is Progenix DBM Putty and Paste used for?
Progenix DBM Putty and Paste is used as a bone graft substitute in orthopedic and spinal surgeries to promote bone growth and healing.
What specialties typically use this device?
Orthopedic surgeons and neurosurgeons commonly use this device in their surgical procedures.
What are the FDA-cleared indications?
The FDA-cleared indications include its use as a bone graft substitute in orthopedic and spinal surgeries for patients requiring bone regeneration.
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.