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biomet orthopaedic salvage system osstm - proximal femoral hybrid tibial
Biomet Manufacturing
Summary: The Biomet Orthopaedic Salvage System OSSTM is a modular system used in orthopedic surgeries for complex joint reconstructions, primarily by orthopedic surgeons. It's designed to address severe bone loss or deformities in the proximal femur and tibia.
FDA Clearance Information
Pathway
510K
Number
K142814 ↗
Decision Date
June 25, 2015
Product Code
JDI
Device Class
Class 2
Evidence
0 studies
The Biomet Orthopaedic Salvage System OSSTM was cleared through the FDA 510k pathway on June 25, 2015. Manufactured by Biomet Manufacturing, it is classified as a Class 2 device under product code JDI.
What It Is
The Biomet Orthopaedic Salvage System OSSTM is a modular orthopedic device designed for complex reconstructions of the proximal femur and tibia. It is particularly useful in cases where there is significant bone loss or deformity, often due to trauma, tumor resection, or revision arthroplasty. The system allows for a hybrid approach, combining different materials and components to tailor the reconstruction to the patient's specific anatomical and clinical needs.
Clinical Applications
This device is commonly used in orthopedic surgeries involving complex joint reconstructions, such as in cases of severe osteoarthritis, bone tumors, or failed previous joint replacements. It is typically utilized in hospital settings by orthopedic surgeons specializing in joint reconstruction or oncology. The system is particularly beneficial for patients with significant bone defects or deformities that require a customized surgical approach.
Indications for Use
The FDA-cleared indications for this device include use in patients who require complex reconstruction of the proximal femur or tibia due to conditions like severe bone loss, deformities, or after tumor resection. It is suitable for patients undergoing revision surgeries where standard implants are insufficient.
Practical Considerations
The Biomet Orthopaedic Salvage System OSSTM offers modular components that can be customized to fit the patient's anatomy. Surgeons should be familiar with the system's assembly and compatibility with existing implants. Proper preoperative planning and sizing are crucial for optimal outcomes.
Frequently Asked Questions
What is Biomet Orthopaedic Salvage System OSSTM used for?
It is used for complex reconstructions of the proximal femur and tibia in cases of severe bone loss or deformity.
What specialties typically use this device?
Orthopedic surgeons, particularly those specializing in joint reconstruction or orthopedic oncology, typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring complex reconstruction of the proximal femur or tibia due to conditions like severe bone loss, deformities, or post-tumor resection.
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.