Biopro Polar Head
FDA 510(k)Class II (US FDA 510(k))
by Biopro, Inc.
Identifiers
- 510(k) Number
- K100761 FDA 510(k)
- FDA Product Code
- KWY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3390 FDA 510(k)
- Regulation Number
- 888.3390 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Biopro Bipolar Head is a hip prosthesis component designed for use in primary or revision hemiarthroplasty of the hip. It functions as a self-aligning bipolar head that mates with a femoral stem to provide a bearing surface for hip joint movement.
The device consists of a cobalt chrome outer shell, a UHMWPE liner, a UHMWPE retention ring, and a Ti-6AI-4v spring. It is available in outer diameters ranging from 38-60mm and is intended for use by orthopedic surgeons in clinical settings. This device has received FDA 510k authorization.
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: BIOPRO POLAR HEAD (K100761) — FDA 510 (k) | Innolitics, BIOPRO BIPOLAR HEAD, MODELS 18130-18152 - Innolitics, PDF 510K Summary K100761 Submitter BioPro, Inc. Contact David Mrak
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K100761 | Class II | Active |
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Manufacturer
- Manufacturer
- Biopro, Inc.
Sources (1)
- FDA 510(k) K100761 24 fields · synced Sep 23, 2026