Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K152169 FDA 510(k)
- FDA Product Code
- JWH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3560 FDA 510(k)
- Regulation Number
- 888.3560 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts are modular components designed for total knee arthroplasty (knee replacement). This system includes a cruciate-retaining (CR) femoral component paired with E-Vitalize CR and UC (unconstrained) tibial inserts, engineered for cemented fixation. The design prioritizes bone conservation, stability, and range of motion through optimized geometry and material properties. These components are categorized under orthopedic knee prostheses and are intended for use in primary total knee replacements requiring balanced ligamentous support.
The device is supplied as a sterile, single-use orthopedic implant kit, intended for cemented fixation in total knee arthroplasty procedures. Tibial inserts are interchangeable with compatible femoral components and trays, available in CR and UC variants to accommodate varying patient anatomy and ligamentous balance. The system adheres to FDA 510(k) clearance (K152169) under the Orthopedic Devices Advisory Committee (OR) and is classified under product code JWH. Storage requires adherence to manufacturer guidelines for sterile packaging integrity, and sizing aligns with standard femoral component dimensions (referenced in accompanying surgical instrumentation).
Frequently asked questions
What is the Balanced Knee System TriMax CR Femoral Component and E-Vitalize Tibial Inserts used for?
This system is designed specifically for total knee arthroplasty (knee replacement) in patients requiring balanced ligamentous support. The cruciate-retaining (CR) femoral component pairs with E-Vitalize tibial inserts—available in CR (cruciate-retaining) and UC (unconstrained) variants—to adapt to individual anatomy and ligament balance. The modular design prioritizes bone conservation, stability, and range of motion through optimized geometry and material properties, making it suitable for primary knee replacements where ligamentous balance is critical.
How is the Balanced Knee System supplied, and is it reusable?
The system is supplied as a sterile, single-use orthopedic implant kit intended for cemented fixation during total knee arthroplasty. It is not designed for reuse, as single-use implants are standard practice in orthopedic surgery to ensure sterility and patient safety. The kit includes the femoral component and tibial inserts, along with compatible surgical instrumentation for proper sizing and placement.
Are the tibial inserts interchangeable, and what variants are available?
Yes, the tibial inserts are interchangeable with compatible femoral components and trays. Two variants are available: E-Vitalize CR (cruciate-retaining) and E-Vitalize UC (unconstrained). These variants allow surgeons to select the insert type based on the patient’s ligamentous anatomy and functional requirements, ensuring a tailored fit for optimal knee function post-surgery.
How should the Balanced Knee System be stored to maintain sterility?
Storage must follow the manufacturer’s guidelines to preserve the sterile integrity of the packaging. The kit should be kept in its original, unopened sterile barrier until immediate preoperative use. Avoid exposure to moisture, extreme temperatures, or physical damage, as these can compromise sterility. Always refer to the accompanying instructions for specific storage conditions and expiration dates.
What regulatory clearance does the Balanced Knee System hold, and how is it classified?
The Balanced Knee System TriMax CR Femoral Component and E-Vitalize Tibial Inserts holds FDA 510(k) clearance under the product code JWH, classified under orthopedic knee prostheses. The clearance was granted through the Traditional 510(k) review pathway and is substantively equivalent to a predicate device, as determined by the Orthopedic Devices Advisory Committee (OR). This classification ensures compliance with U.S. regulatory standards for orthopedic implants.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BKS® TriMax® | Knee Replacement System for Modern Needs, BKS® Total Knee System | Ortho Development, Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and ..., Balanced Knee - Ortho Development - PDF Catalogs - MedicalExpo
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152169 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ortho Development Corporation
Sources (1)
- FDA 510(k) K152169 24 fields · synced Oct 1, 2026