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solcotrans orthopaedic drainage reinfusion system
Solco Basle
Summary: The Solcotrans Orthopaedic Drainage Reinfusion System is used for postoperative blood salvage in orthopaedic surgeries. It is primarily used in total joint arthroplasty to reduce the need for allogeneic blood transfusions. Key evidence shows a significant reduction in transfusion requirements.
FDA Clearance Information
Pathway
510K
Number
K913247 ↗
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 under product code CAC.
What It Is
The Solcotrans Orthopaedic Drainage Reinfusion System is a medical device designed to collect and reinfuse autologous blood during the postoperative period in orthopaedic surgeries. It is intended to reduce the need for allogeneic blood transfusions by allowing the reinfusion of the patient's own blood.
Clinical Applications
This device is commonly used in elective total joint arthroplasty, such as total knee and hip replacements. It is particularly beneficial in scenarios where minimizing the use of donor blood is desired, thereby reducing the risks associated with transfusions.
Evidence Summary
The available literature includes two studies published in 1993 and 1994, involving prospective and randomized controlled trials. These studies evaluated the efficacy of the Solcotrans system in reducing transfusion requirements in patients undergoing total joint arthroplasty.
Reported Outcomes
Published studies report that the use of the Solcotrans Orthopaedic Drainage Reinfusion System significantly reduces the need for postoperative blood transfusions. 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 in total joint arthroplasty.
Safety Profile
Reported complications include no specific adverse events directly attributed to the use of the Solcotrans system in the provided studies. The evidence suggests that the system is safe for use in the intended clinical scenarios.
Evidence Limitations
The evidence is limited to two studies with relatively small sample sizes. Further research is needed to confirm these findings across larger and more diverse patient populations. Additionally, long-term safety data is not available.
Frequently Asked Questions
What are the clinical indications for Solcotrans Orthopaedic Drainage Reinfusion System?
The device is indicated for use in postoperative blood salvage in orthopaedic surgeries, particularly in total joint arthroplasty.
What outcomes have been reported in clinical studies?
Studies report a significant reduction in the need for postoperative blood transfusions when using the Solcotrans system.
What complications have been reported?
No specific complications directly related to the device were reported in the provided studies.
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.