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columbus ultra congruent uc tibial insert gliding surface
Aesculap
Summary: The Columbus Ultra Congruent UC Tibial Insert is a component used in total knee replacement surgeries to improve joint stability and function. It is primarily used by orthopedic surgeons in patients requiring knee arthroplasty.
FDA Clearance Information
Pathway
510K
Number
K053579 ↗
Decision Date
May 17, 2006
Product Code
JWH
Device Class
Class 2
Evidence
0 studies
The Columbus Ultra Congruent UC Tibial Insert by Aesculap was cleared via the FDA 510k pathway on May 17, 2006. It is classified as a Class 2 medical device under product code JWH.
What It Is
The Columbus Ultra Congruent UC Tibial Insert is a prosthetic component designed for use in total knee arthroplasty (TKA). It serves as the gliding surface for the tibial component, providing enhanced stability and congruency during knee movement. This insert is particularly beneficial in cruciate-sacrificing knee replacement procedures, where the posterior cruciate ligament is removed.
Clinical Applications
This device is commonly used in orthopedic surgeries, specifically in total knee replacements. It is suitable for patients with severe knee arthritis or joint damage requiring knee replacement. The insert is used in hospital operating rooms and orthopedic specialty centers, primarily by orthopedic surgeons specializing in joint replacement.
Indications for Use
The Columbus Ultra Congruent UC Tibial Insert is indicated for patients undergoing total knee arthroplasty, particularly in cases where the posterior cruciate ligament is sacrificed. It is designed to improve joint stability and reduce complications such as mid-flexion instability.
Practical Considerations
The Columbus Ultra Congruent UC Tibial Insert is available in various sizes to accommodate different patient anatomies. It is compatible with other components of the Columbus knee system. Surgeons should ensure proper alignment and fixation to optimize outcomes.
Related Literature
The linked study investigated the impact of optimized implant designs, including the Columbus Ultra Congruent UC Tibial Insert, on mid-flexion stability in cruciate-sacrificing total knee replacements. Using musculoskeletal multibody simulation, the study found that these designs could enhance stability and reduce anterior-posterior translation during squat motions. However, the study's limitations include its reliance on simulation data rather than clinical outcomes.
Frequently Asked Questions
What is the Columbus Ultra Congruent UC Tibial Insert used for?
It is used in total knee replacement surgeries to provide a stable gliding surface for the tibial component, particularly in cruciate-sacrificing procedures.
What specialties typically use this device?
Orthopedic surgeons specializing in joint replacement and knee arthroplasty commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in total knee arthroplasty, especially when the posterior cruciate ligament is removed, to enhance knee stability and function.
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.