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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 ?
510(k)
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.
FDA-Cleared Indications
- Complex reconstruction of the proximal femur or proximal tibia when substantial bone loss or deformity is present.
- Reconstruction after resection of bone tumors involving the proximal femur or tibia.
- Revision reconstruction when standard orthopedic implants are insufficient because of bone loss or deformity.
Clinical Applications
- Modular reconstruction of the proximal femur after tumor resection or major bone loss.
- Modular reconstruction of the proximal tibia after tumor resection or major bone loss.
- Revision hip or knee arthroplasty when existing components cannot adequately address the bone defect.
- Reconstruction of complex proximal femoral or tibial deformities using compatible modular components.
Practical Considerations
- The system includes modular components, so preoperative imaging, templating, component selection, and assessment of remaining bone are important.
- The surgeon must verify compatibility among the selected components and with any retained or revised implant components; components should not be mixed outside their labeling.
- Implant selection and fixation depend on bone quality, defect location, soft-tissue function, alignment, and joint stability.
- MRI safety and conditional scanning information must be confirmed in the current manufacturer’s instructions for use for the exact implanted components. MRI conditions may differ by component and configuration.
- Contraindications, warnings, and handling requirements are defined in the current FDA-cleared labeling. Infection, inadequate bone stock or soft-tissue support, and inability to obtain stable fixation may affect candidacy.
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.