Biomet Modular Femoral Revision System
FDA 510(k)Class III (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K090757 FDA 510(k)
- FDA Product Code
- KWA FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3330 FDA 510(k)
- Regulation Number
- 888.3330 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Biomet Modular Femoral Revision System is a semi-constrained, uncemented metal prosthesis designed for hip revision surgery. It provides modular components to address complex femoral defects, enabling customised reconstruction while maintaining stability and alignment in the femur.
This system is intended for use in orthopaedic settings and is supplied as a reusable surgical implant. Components are sterilised via ethylene oxide or gamma irradiation, with MRI safety classified as non-conditionally safe. Multiple sizes and modular configurations are available to accommodate varying anatomical requirements, and its use is authorised under FDA 510(k) clearance (K090757) for orthopaedic applications.
Frequently asked questions
What types of femoral defects is the Biomet Modular Femoral Revision System designed to address in hip revision surgery?
The Biomet Modular Femoral Revision System is specifically engineered to address complex femoral defects encountered during hip revision surgery. Its modular design allows for customised reconstruction by accommodating varying anatomical requirements, ensuring stability and proper alignment in the femur. This flexibility is particularly useful when dealing with severe bone loss or structural damage.
How is the Biomet Modular Femoral Revision System sterilised, and what does this mean for its reuse?
The system’s components are sterilised using either ethylene oxide or gamma irradiation, which are both validated methods for ensuring sterility in reusable medical devices. Since it is described as a reusable surgical implant, this means the components can be cleaned, sterilised, and reused multiple times under proper infection control protocols, provided they remain intact and meet manufacturer guidelines.
What safety considerations should clinicians keep in mind regarding MRI compatibility when using this device?
The Biomet Modular Femoral Revision System is classified as non-conditionally safe for MRI, meaning patients with this implant can undergo MRI scans without the risk of device failure or injury. However, clinicians should still follow standard MRI safety protocols, such as verifying the specific MRI machine settings and ensuring the scan parameters align with the device’s documented compatibility to avoid potential complications.
Are there different sizes or configurations available for this system, and how does this benefit surgeons?
Yes, the Biomet Modular Femoral Revision System offers multiple sizes and modular configurations to match a wide range of anatomical variations. This modularity allows surgeons to customise the implant to the patient’s specific femoral anatomy, improving fit, stability, and functional outcomes during revision surgery. It also helps address varying degrees of bone loss or deformity, enhancing the system’s versatility in complex cases.
What regulatory pathway was followed for the FDA clearance of this device, and what does this mean for its use in clinical practice?
The Biomet Modular Femoral Revision System received FDA clearance through a 510(k) submission, specifically under the Traditional 510(k) review pathway, with a decision code of SESE (Substantially Equivalent in Safety and Effectiveness). This means the device was determined to be substantially equivalent to a legally marketed predicate device in terms of technology and intended use. Clinically, this clearance indicates that the device meets FDA standards for safety and performance, allowing it to be legally marketed and used in orthopaedic settings for hip revision surgery as described.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K090757 | Class III | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K090757 24 fields · synced Sep 18, 2026