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biomet orthopaedic salvage system oss
Biomet
Summary: The Biomet Orthopaedic Salvage System OSS is a device used primarily for complex knee fractures and distal femoral replacements. Key evidence highlights its use in elderly patients with distal femur fractures and oncologic patients requiring distal femoral replacement.
FDA Clearance Information
Pathway
510K
Number
K141331 ↗
Decision Date
October 27, 2014
Product Code
JDI
Device Class
Class 2
Evidence
0 studies
The Biomet Orthopaedic Salvage System OSS was cleared by the FDA via the 510(k) pathway on October 27, 2014. It is manufactured by Biomet and classified as a Class 2 device.
What It Is
The Biomet Orthopaedic Salvage System OSS is designed for use in complex knee surgeries, including total knee arthroplasty revisions and distal femoral replacements. It is intended to provide structural support and restore function in cases of severe bone loss or damage.
Clinical Applications
This device is commonly used in scenarios involving complex knee fractures, particularly in elderly patients with osteoporotic bone, and in oncologic patients requiring distal femoral replacement. It is also utilized in revision surgeries following total knee arthroplasty.
Evidence Summary
The available literature includes a case series and a study on long-term outcomes in oncologic patients, with publication years in 2021. These studies provide insights into the device's application in complex knee fractures and distal femoral replacements.
Reported Outcomes
Published studies report that the Biomet Orthopaedic Salvage System OSS is effective in managing complex distal femur fractures in elderly patients, with average WOMAC scores of 17.25 and Oxford knee scores of 35.25. The device is also used in oncologic patients for distal femoral replacement, although specific outcomes were not detailed in the provided evidence.
Safety Profile
Reported complications include postoperative anemia in three cases, with no implant-related complications noted in the case series. Long-term complications in oncologic patients were not detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the small sample size and retrospective nature of the case series. Further research is needed to evaluate long-term outcomes and complications in a larger cohort of patients.
Frequently Asked Questions
What are the clinical indications for Biomet Orthopaedic Salvage System OSS?
The device is indicated for complex knee fractures, distal femoral replacements, and revision surgeries following total knee arthroplasty.
What outcomes have been reported in clinical studies?
Studies report average WOMAC scores of 17.25 and Oxford knee scores of 35.25 in elderly patients with distal femur fractures.
What complications have been reported?
Safety data indicate postoperative anemia in three cases, with no implant-related complications reported in the case series.
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.