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b-ONE Bipolar Head

FDA 510(k)

Class II (US FDA 510(k))

510(k) K253357

by B-One Ortho, Corp.

Identifiers

510(k) Number
K253357 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 b-ONE Bipolar Head is a hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis. It is classified as a Class II medical device under regulation number 21 CFR 888.3390.

The device received FDA 510(k) clearance (K253357) on April 13, 2026, and was determined to be substantially equivalent. It is manufactured by B-One Ortho, Corp. and is intended for orthopedic 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: b-ONE® Bipolar Head (K253357) — FDA 510 (k) | Innolitics, B-One Ortho, Corp. FDA 510(k) Orthopedic Products - Latest 2026, b-ONE® Bipolar Head - BEUDAMED

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
B-One Ortho, Corp.

Sources (1)

  • FDA 510(k) K253357 24 fields · synced Sep 27, 2026