Ascent XXL Closed Box Femoral Component
FDA 510(k)Class II (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K002772 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 Ascent XXL Closed Box Femoral Component is a semi-constrained, cemented knee prosthesis designed for patellofemorotibial use. It is constructed from a polymer, metal, and polymer combination and functions as part of a knee replacement system.
This single-use orthopedic device is supplied sterile and is intended for surgical implantation in the knee. It is regulated under FDA class 2 with product code JWH and is stored in accordance with standard medical device protocols. The device received FDA 510(k) clearance under the Special pathway with a substantially equivalent determination.
Frequently asked questions
What is the Ascent XXL Closed Box Femoral Component used for?
It is a semi-constrained, cemented knee prosthesis designed for patellofemorotibial use as part of a knee replacement system. It is intended for surgical implantation in the knee to restore joint function and mobility.
How is the Ascent XXL Femoral Component supplied?
The device is supplied sterile and is intended for single-use only. It is packaged to maintain sterility until the point of surgical implantation, ensuring safe and hygienic use in the operating room.
Is the Ascent XXL Femoral Component reusable?
No, it is a single-use device. Once implanted, it is not designed for removal, cleaning, or reimplantation. Each unit is intended for one patient use only to prevent cross-contamination and ensure device integrity.
What materials is the Ascent XXL Femoral Component made from?
It is constructed from a combination of polymer, metal, and polymer materials. This composite design provides structural support, durability, and compatibility with the knee joint environment.
How should the Ascent XXL Femoral Component be stored?
It should be stored in accordance with standard medical device protocols, typically in a cool, dry environment away from direct sunlight and extreme temperatures. Storage conditions help preserve sterility and material integrity until use.
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: K002772 FDA 510 (k) - ASCENT XXL CLOSED BOX FEMORAL COMPONENT, Ascent Xxl Closed Box Femoral Component 510(k) K002772 - fda.report, Ascent Xxl Closed Box Femoral Component 510(k) K002772 - fda.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K002772 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K002772 24 fields · synced Sep 24, 2026