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solcotrans orthopaedic drainage reinfusion system
Solco Basle
Summary: The Solcotrans Orthopaedic Drainage Reinfusion System is designed for postoperative blood salvage in total joint arthroplasty. It reduces the need for allogeneic blood transfusions. Key evidence shows a significant reduction in transfusion requirements.
FDA Clearance Information
Pathway
510K
Number
K913177 ↗
Decision Date
February 25, 1993
Product Code
CAC
Device Class
Class 2
Evidence
0 studies
The Solcotrans Orthopaedic Drainage Reinfusion System was cleared by the FDA via the 510(k) pathway on February 25, 1993. It is manufactured by Solco Basle and classified as a Class 2 device.
What It Is
The Solcotrans Orthopaedic Drainage Reinfusion System is a medical device used to collect and reinfuse autologous blood during postoperative recovery in orthopedic surgeries, particularly total joint arthroplasty. It aims to minimize the need for allogeneic blood transfusions.
Clinical Applications
This device is commonly used in elective total joint arthroplasty procedures, such as total knee and hip replacements, to manage postoperative blood loss and reduce reliance on donor blood transfusions.
Evidence Summary
The available literature includes two studies, both published in the early 1990s, evaluating the efficacy of the Solcotrans system in reducing blood transfusion needs. These studies involved a total of 83 patients.
Reported Outcomes
Published studies report that the use of the Solcotrans system significantly reduces the need for postoperative blood transfusions in total joint arthroplasty. In one study, only 25% of patients required transfusions compared to 83% in the control group. Another study confirmed the effectiveness of the system in reducing transfusion rates.
Safety Profile
Reported complications include the general risks associated with postoperative blood salvage systems, but specific adverse events were not detailed in the provided studies. Overall, the system is considered safe for its intended use.
Evidence Limitations
The evidence is limited to two studies with relatively small sample sizes and lacks detailed safety data. Further research is needed to confirm long-term safety and efficacy across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Solcotrans Orthopaedic Drainage Reinfusion System?
The device is indicated for use in postoperative blood salvage during total joint arthroplasty to reduce the need for allogeneic blood transfusions.
What outcomes have been reported in clinical studies?
Studies have shown a significant reduction in the need for postoperative blood transfusions when using the Solcotrans system.
What complications have been reported?
Specific complications were not detailed in the studies provided, but the system is generally considered safe for its intended use.
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.