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Columbus Ultra Congruent Uc Tibial Insert Gliding Surface
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 ?
510(k)
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.
FDA-Cleared Indications
- Use as a tibial insert component in total knee arthroplasty with compatible Columbus knee system components.
- Use in cruciate-sacrificing total knee replacement procedures in which the posterior cruciate ligament is removed or is not retained.
Clinical Applications
- Providing the bearing or gliding surface in a total knee replacement.
- Supporting knee joint stability after removal or sacrifice of the posterior cruciate ligament.
- Use with compatible femoral and tibial baseplate components of the Columbus knee system.
- Treatment of patients undergoing total knee arthroplasty for end-stage knee joint disease when replacement is clinically indicated.
Practical Considerations
- The insert must be matched to the compatible Columbus femoral and tibial components and selected in an appropriate size and thickness.
- Correct bone preparation, component alignment, soft-tissue balancing and secure seating are important for stability and function.
- The device is implanted during open orthopedic surgery, generally under regional or general anesthesia.
- MRI safety and conditional-use information should be confirmed in the current manufacturer labeling for the complete implanted knee system; the insert should not be evaluated separately from its metal components.
- Contraindications and precautions include active infection, inadequate bone or soft-tissue support, and other conditions that make total knee arthroplasty unsuitable.
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.