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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 510K
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.
Clinical Applications
This device is commonly used in orthopedic surgeries, such as spinal fusion, fracture repair, and joint reconstruction, where bone grafting is necessary. It is also utilized in dental surgeries for procedures like ridge augmentation and sinus lifts. The device is suitable for use in hospitals and surgical centers, primarily by orthopedic surgeons, neurosurgeons, and dental specialists.
Indications for Use
Orthoblast II Putty and Paste is indicated for patients requiring bone grafting due to conditions like fractures, bone defects, or degenerative bone diseases. It is used to facilitate bone healing and regeneration in both orthopedic and dental contexts.
Practical Considerations
Orthoblast II Putty and Paste is available in various sizes to accommodate different surgical needs. It is compatible with standard surgical techniques and instruments. Surgeons should ensure proper handling to maintain sterility and effectiveness during the procedure.
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.