Genesis II Total Knee System
by Smith & Nephew, Inc. 510(k)
Active
510(k) K030612
Overview
The Genesis II Total Knee System is a cemented primary and revision knee arthroplasty device designed for total knee replacement. It features a femoral component with a deeper and more lateralized trochlear groove, along with an externally rotated design to improve alignment and stability during implantation.
This system is intended for use in orthopedic surgery settings and is supplied as a sterile, single-use device. It is approved under FDA 510(k) clearance (K030612) as substantially equivalent to predicate devices, with components including femoral, tibial, and patellar implants. Storage and handling must comply with manufacturer instructions to maintain sterility and functionality.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK030612 | Date27 May 2003 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- MBH
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3565
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Smith & Nephew, Inc.
Questions
What types of knee surgeries is the Genesis II Total Knee System designed for, and how does its design improve outcomes?
The Genesis II Total Knee System is designed for both primary and revision total knee arthroplasty procedures. Its femoral component features a deeper, more lateralized trochlear groove and an externally rotated design, which helps improve alignment and stability during implantation. These design elements are intended to enhance the fit and function of the knee joint, potentially leading to better long-term outcomes for patients.
Is the Genesis II Total Knee System meant for reuse, or is it a single-use device, and how should it be stored?
The Genesis II Total Knee System is supplied as a sterile, single-use device. To maintain sterility and functionality, storage and handling must strictly follow the manufacturer’s instructions provided by Smith & Nephew, Inc. This ensures the device remains uncontaminated and ready for use in a single surgical procedure.
What components are included in the Genesis II Total Knee System, and how are they intended to work together?
The Genesis II Total Knee System includes three primary components: femoral, tibial, and patellar implants. These components are designed to work together during total knee replacement surgery, with the femoral component fitting over the thigh bone, the tibial component attaching to the shin bone, and the patellar component covering the kneecap. The system’s design aims to restore joint function and stability through precise alignment and compatibility of these parts.
How is the regulatory status of the Genesis II Total Knee System determined, and what does that mean for its use in clinical settings?
The Genesis II Total Knee System holds FDA 510(k) clearance (K030612), which means it has been determined to be substantially equivalent to predicate devices already on the market. This clearance indicates that the device meets FDA standards for safety and effectiveness for its intended use in orthopedic surgery settings, allowing clinicians to rely on its regulatory approval when incorporating it into surgical procedures.