Biocore9 Femoral Head Resurfacing Component
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K201219 FDA 510(k)
- FDA Product Code
- KXA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3400 FDA 510(k)
- Regulation Number
- 888.3400 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Biocore9 Femoral Head Resurfacing Component is a prosthesis designed for hip resurfacing procedures to preserve femoral bone stock in patients. It is intended for use in young and active individuals who require hip joint restoration. The device is available in multiple sizes including 39.5, 41, 42.5, 44, 45.5, 47, 49, 51 and 52.5 mm outside diameters.
The Biocore9 Femoral Head Resurfacing Component is supplied as a single-use device and is not MRI safe. It is manufactured by Biocore9, LLC and has received FDA 510(k) clearance with the product code KXA. The device is classified under regulation number 888.3400 and is intended for orthopedic use.
Frequently asked questions
What is the Biocore9 Femoral Head Resurfacing Component used for?
The Biocore9 Femoral Head Resurfacing Component is a prosthesis designed for hip resurfacing procedures to preserve femoral bone stock in patients, particularly young and active individuals who require hip joint restoration.
What sizes are available for the Biocore9 Femoral Head Resurfacing Component?
The device is available in multiple sizes including 39.5, 41, 42.5, 44, 45.5, 47, 49, 51 and 52.5 mm outside diameters to accommodate various patient anatomies.
Is the Biocore9 Femoral Head Resurfacing Component reusable or MRI safe?
The Biocore9 Femoral Head Resurfacing Component is supplied as a single-use device and is not MRI safe, meaning it should not be used in MRI environments and should not be reused on different patients.
What regulatory status does the Biocore9 Femoral Head Resurfacing Component have?
The device has received FDA 510(k) clearance with the product code KXA and is classified under regulation number 888.3400 for orthopedic use, indicating it meets the FDA's requirements for safety and effectiveness.
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: Home | Biocore9 Website, Femoral Resurfacing System | Biocore9 Website, Biocore9, LLC 01-03-0051 Biocore9 Femoral Resurfacing Component, biocore9 femoral head resurfacing component, K201219 FDA 510(k) - Biocore9 Femoral Head Resurfacing Component
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201219 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biocore9, LLC
Sources (1)
- FDA 510(k) K201219 24 fields · synced Sep 22, 2026