đź“‹ FDA Reference
Orthoblast II Putty and Paste
Isotis Orthobiologics
Summary: Orthoblast II Putty and Paste is a bone graft substitute used in orthopedic and dental procedures to promote bone growth. It is typically used by orthopedic surgeons and dental specialists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K050642 ↗
Decision Date ?
December 5, 2005
Product Code ?
MBP
Device Class ?
Class 2
Evidence ?
0 studies
The Orthoblast II Putty and Paste was cleared through the FDA's 510(k) pathway on December 5, 2005, by Isotis Orthobiologics. It is classified as a Class 2 medical device.
What It Is
Orthoblast II Putty and Paste is a synthetic bone graft substitute designed to aid in the regeneration of bone tissue. It typically consists of a combination of demineralized bone matrix and a carrier substance that can be easily molded to fit the surgical site. This device works by providing a scaffold that supports new bone growth, making it useful in various bone repair and reconstruction procedures.
FDA-Cleared Indications
- Use as a bone graft substitute to fill or repair bone defects where bone grafting is clinically indicated.
- Use in orthopedic procedures requiring bone graft material for bone repair, reconstruction, or fusion.
- Use in dental and maxillofacial procedures requiring bone augmentation or reconstruction.
Clinical Applications
- Filling bone defects during orthopedic reconstruction.
- Supporting bone healing during fracture repair.
- Use as graft material in spinal fusion procedures when bone grafting is required.
- Use during joint or other orthopedic reconstruction requiring bone graft substitute material.
- Dental ridge augmentation and other alveolar bone-grafting procedures.
- Maxillary sinus augmentation or sinus-lift procedures.
Practical Considerations
- The putty or paste formulation can be molded or placed to fit the surgical defect and is used with standard surgical techniques.
- Available package sizes may vary by product configuration and should be selected according to the defect size and planned procedure.
- The material must be handled using sterile technique and according to the current manufacturer labeling.
- MRI safety depends on the final implanted or retained material and any accompanying hardware; the current product labeling should be reviewed before MRI.
- Contraindications, precautions, and use in infection, poor bone quality, compromised blood supply, or other high-risk settings should be assessed from the current instructions for use.
Frequently Asked Questions
What is Orthoblast II Putty and Paste used for?
It is used as a bone graft substitute to promote bone growth in orthopedic and dental procedures.
What specialties typically use this device?
Orthopedic surgeons, neurosurgeons, and dental specialists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for bone grafting in procedures requiring bone repair and regeneration, such as fractures 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.