Porous APF/Modular Femoral Component
FDA 510(k)Class II (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K852585 FDA 510(k)
- FDA Product Code
- JDI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3350 FDA 510(k)
- Regulation Number
- 888.3350 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SN FDA 510(k)
The device is a porous APF/modular femoral component, an orthopedic implant designed for femoral replacement in joint arthroplasty procedures. It features a porous surface structure intended to promote bone ingrowth and fixation.
It is supplied as a reusable implant component, manufactured by Biomet, Inc., and was granted FDA 510(k) clearance under K852585 with product code JDI. The device is intended for use in orthopedic surgical settings and is not MRI conditional unless explicitly stated in labeling.
Frequently asked questions
What is the Porous APF/Modular Femoral Component used for?
The device is an orthopedic implant designed for femoral replacement in joint arthroplasty procedures, featuring a porous surface structure intended to promote bone ingrowth and fixation for secure long-term attachment to the femur.
Is the Porous APF/Modular Femoral Component reusable or single-use?
The device is supplied as a reusable implant component, meaning it can be sterilized and used multiple times in surgical procedures, as indicated in the manufacturer's specifications and labeling.
Who manufactures the Porous APF/Modular Femoral Component and what is its FDA authorization?
The device is manufactured by Biomet, Inc., and was granted FDA 510(k) clearance under submission number K852585 with product code JDI, indicating it was found substantially equivalent to a legally marketed predicate device.
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 | K852585 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K852585 24 fields · synced Sep 23, 2026