Depuy Attune Knee System - Cementless Cr And Ps Femoral Componenets
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K140881 FDA 510(k)
- FDA Product Code
- MBH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3565 FDA 510(k)
- Regulation Number
- 888.3565 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Depuy Attune Knee System – Cementless CR and PS Femoral Components are classified as cementless femoral knee arthroplasty devices. These components are designed for use in total knee replacement procedures, providing a fixed-bearing solution for cruciate-retaining (CR) and posterior-stabilized (PS) femoral implants. The system is engineered to integrate with the Attune total knee replacement platform, offering stability and range of motion through its anatomical design. These components are intended for primary total knee arthroplasty in adult patients requiring joint reconstruction.
The cementless femoral components are supplied sterile and intended for single-use in orthopedic surgical settings. They are manufactured to comply with FDA 510(k) clearance under K140881, classified under product code MBH for orthopedic knee prostheses. Components are designed for cementless fixation, ensuring osseointegration with the femoral bone. Storage and handling must adhere to sterile medical device protocols to maintain integrity prior to surgical use.
Frequently asked questions
What are the Depuy Attune Cementless CR and PS Femoral Components used for?
These components are specifically designed for primary total knee arthroplasty in adult patients requiring joint reconstruction. They provide a fixed-bearing solution for cruciate-retaining (CR) and posterior-stabilized (PS) femoral implants, integrating with the Attune total knee replacement platform to enhance stability and range of motion through anatomical design.
Are the Depuy Attune Cementless CR and PS Femoral Components supplied sterile?
Yes, the components are supplied sterile to ensure safety and efficacy in orthopedic surgical settings. Sterility is critical for single-use medical devices like these, and proper handling protocols must be followed to maintain their integrity before use.
Are these femoral components intended for single-use or reusable?
These components are explicitly intended for single-use only. The design and sterility requirements align with best practices for orthopedic implants to prevent cross-contamination and ensure patient safety during surgical procedures.
How are the Depuy Attune Cementless CR and PS Femoral Components fixed to the bone?
The components are engineered for cementless fixation, which promotes osseointegration—the direct structural and functional connection between living bone and the surface of the implant. This method eliminates the need for bone cement and relies on the natural healing process of the bone.
What storage and handling guidelines apply to these femoral components?
Storage and handling must strictly adhere to sterile medical device protocols to preserve the components’ integrity before surgical use. This includes maintaining sealed packaging, avoiding contamination, and following manufacturer-recommended conditions to ensure the components remain sterile and functional until implantation.
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: ATTUNE™ Cementless Rotating Platform (RP) Total Knee, ATTUNE™ Knee System | Surgical Technique | DePuy Synthes, Depuy Attune Knee System - Cementless Cr and Ps Femoral Componenets ..., attune - Depuy Synthes - PDF Catalogs | Technical Documentation
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140881 | Class II | Active |
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Manufacturer
- Manufacturer
- Depuy (ireland)
- FDA Applicant
- Depuy(Ireland)
Sources (1)
- FDA 510(k) K140881 24 fields · synced Oct 1, 2026