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FDA 510(k)

b-ONE® Bipolar Head

K-Number: K253357 · 2026-04-13

ApplicantB-One Ortho, Corp.
Decision Date2026-04-13
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

b-ONE® Bipolar Head is a medical device manufactured by B-One Ortho, Corp.. It received FDA 510(k) clearance on 2026-04-13 under approval number K253357. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the b-ONE® Bipolar Head?

b-ONE® Bipolar Head is a medical device that received FDA 510(k) clearance on 2026-04-13. It is manufactured by B-One Ortho, Corp.. The 510(k) number is K253357.

When was b-ONE® Bipolar Head approved by the FDA?

b-ONE® Bipolar Head received FDA 510(k) clearance on 2026-04-13, under approval number K253357.

What company makes b-ONE® Bipolar Head?

b-ONE® Bipolar Head is manufactured by B-One Ortho, Corp..

What is the FDA product code for b-ONE® Bipolar Head?

The FDA product code for b-ONE® Bipolar Head is KWY.

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Related Devices (Code: KWY)

K152439U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation K170072Fitmore® Hip StemZimmer GmbH K173455SurgTech Bipolar Head SystemSurgtech, Inc. K180130ELEOS™ Bipolar Acetabular SystemOnkos Surgical, Inc. K16308140-42mm BiPolar Head and 22mm Femoral HeadSignature Orthopaedics Pty, Ltd. K192236Fitmore Hip StemZimmer GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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