Description

The Bethesda Knee Replacement Pack is a specialized medical device designed for orthopedic use, specifically in knee replacement surgeries. This advanced prosthesis serves as a semi-constrained, uncemented solution, featuring a porous-coated design that facilitates secure implantation within the body.

Material Composition

• Metal and Polymer: Constructed from high-quality metal and polymer materials, ensuring durability and compatibility with the human body.
• Porous Coating: The porous coating enhances integration with the surrounding bone tissue, promoting stability and longevity.

Intended Use

This device is intended for patients requiring knee joint replacement, providing a reliable and effective solution for restoring mobility and reducing joint pain. Its design mimics the natural patellofemoral-tibial joint, offering improved movement and comfort post-surgery.

Device Classification

• Class II Medical Device: As a Class II medical device, it adheres to stringent regulatory standards, ensuring safety and performance.
• Product Code MBH: Identified under product code MBH, it complies with recognized consensus standards related to materials, coatings, wear, fatigue, and performance testing.

Regulatory Compliance

The Bethesda Knee Replacement Pack is not exempt from Good Manufacturing Practice (GMP) requirements, highlighting its commitment to quality manufacturing processes. Although it is not classified as a life-sustaining or life-support device, its role in enhancing quality of life through improved joint function is significant.

Benefits

• Enhanced Mobility: Aims to restore knee function effectively, allowing patients to return to daily activities with reduced discomfort.
• Long-Term Performance: Engineered for long-term performance, minimizing the need for revision surgeries.

This knee replacement pack represents a critical advancement in orthopedic prosthetics, offering patients a dependable option for knee joint restoration.