Genesis II Total Knee System, Legion Revision Knee System, Journey Bcs Knee System
510(k) K071790
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK071790 | Date17 Aug 2007 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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
Overview
AI-generated summary, 19 Sep 2026
The Genesis II Total Knee System, Legion Revision Knee System, and Journey BCS Knee System are modular orthopedic implants designed for total knee arthroplasty, including primary and revision procedures. These systems provide options for cementless fixation, cruciate-retaining, and posterior-stabilized designs to address diverse patient anatomies and surgical approaches.
The devices are supplied as sterile, single-use implants intended for use in orthopedic surgery settings. The Genesis II features a thinner medial posterior condyle with built-in external rotation, while the Legion Revision Knee System offers symmetric posterior condyles. Authorized under FDA 510(k) clearance (K071790), these systems adhere to traditional review standards and are categorized under the product code MBH for orthopedic knee prostheses.
Other devices from Smith & Nephew, Inc.
Questions
AI-generated answers, 19 Sep 2026
Are these knee systems designed for use in both primary and revision surgeries, and how does the modularity help in clinical decision-making?
Yes, the Genesis II Total Knee System, Legion Revision Knee System, and Journey BCS Knee System are specifically designed for both primary total knee arthroplasty and revision procedures. The modularity allows surgeons to select components tailored to individual patient anatomies, such as cruciate-retaining or posterior-stabilized designs, and fixation methods like cementless options. This flexibility ensures better alignment, stability, and long-term outcomes across a wide range of cases.
How are these knee systems supplied, and what precautions should be taken during handling to maintain sterility?
These knee systems are supplied as sterile, single-use implants, meaning each component is intended for one surgical procedure only. To maintain sterility, they should be handled using aseptic techniques—such as wearing gloves, avoiding direct contact with unsterile surfaces, and following manufacturer-provided packaging instructions. Single-use design minimizes contamination risks and ensures patient safety.
What key anatomical differences distinguish the Genesis II from the Legion Revision Knee System, and how might these affect surgical planning?
The Genesis II features a thinner medial posterior condyle with built-in external rotation, which may better accommodate certain patient anatomies or surgical approaches requiring precise alignment. In contrast, the Legion Revision Knee System offers symmetric posterior condyles, designed to provide stability and fit in more complex revision cases where bone loss or deformity is present. These differences allow surgeons to select the system that best matches the patient’s specific needs, whether for primary or revision surgery.
Are these systems compatible with traditional orthopedic surgical workflows, and what regulatory pathway was followed for their clearance?
Yes, these systems are designed to integrate with standard orthopedic surgical workflows, offering modularity and familiar fixation options like cementless designs. They were cleared through the FDA’s 510(k) pathway under Traditional Review, categorized under product code MBH for orthopedic knee prostheses. The clearance was granted as substantially equivalent to predicate devices, adhering to established safety and effectiveness standards for knee arthroplasty implants.