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The VEGA Knee System is indicated for use in reconstruction of the diseased by ostearthritis, theumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties where pain, deformity or dysfunction persist and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.

Posterior Stabilized (PS) components are also for absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint.

The VEGA Knee System is designed for use with bone cement.

VEGA Knee System is a semi-constrained cemented prosthesis with a posterior stabilized (PS) design. The femoral component, tibial plateau, extension stems and obturators are manufactured from Cobalt Chromium Molybdenum allov (CoCrMo), with an optional Zirconium nitride (ZrN) coating. The tibial gliding surfaces (inserts) and patella are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The tibial plug is made of PEEK.

VEGA Knee System is made up of numerous components available in various sizes. The VEGA Knee System is compatible with Aesculap Columbus cruciate retaining/posterior stabilizing tibial plateaus (CR/PS and CRA/PSA) and augments.

All components are sterile and intended for single use only.

This document is a 510(k) premarket notification for the VEGA Knee System. It does not contain information about the acceptance criteria or a study proving that a device (in the context of an AI/ML device) meets acceptance criteria. Instead, it discusses the regulatory process for a knee replacement system.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to previously cleared medical devices based on design, materials, and intended use, rather than presenting a performance study with acceptance criteria in the way you've described for AI/ML devices.

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