FDA.report

510(k) K253357

Device
b-ONE® Bipolar Head
Applicant
B-One Ortho, Corp.
510(k) number
K253357
Product code
KWY
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-13
Date received
2025-09-30
Regulation
888.3390
Classification name
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Allison Gecik
Address
3 Wing Dr., Suite 259 Cedar Knolls NJ US 07927 07927

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code KWY

510(k)DeviceApplicantDecision date
K243634Maxx Libertas Bipolar Hip Head (Bipolar Hip)Maxx Orthopedics, Inc.2025-08-25
K231526CORAIL Cemented Femoral StemDepuy Ireland UC2023-12-19
K223441SpaceFlex Acetabular CupG21, S.R.L.2023-03-23
K221794Vario-Cup SystemWaldemar Link GmbH & Co. KG2022-07-20
K220492COPAL exchange G hip spacerHeraeus Medical GmbH2022-03-23
K200709Kyocera Bipolar Hip SystemKyocera Medical Technologies, Inc.2020-04-17
K192236Fitmore Hip StemZimmer GmbH2019-11-05
K191016COPAL exchange G Hip and Knee SpacersHeraeus Medical GmbH2019-11-01
K191297iNSitu Bipolar Hip SystemTheken Companies, LLC2019-09-17
K191569Implantcast ic-Bipolar Head SystemImplantcast GmbH2019-08-28
K183114Corin BiPolar-iCorin U.S.A. Limited2019-06-05
K173455SurgTech Bipolar Head SystemSurgtech, Inc.2018-06-14
K180130ELEOS™ Bipolar Acetabular SystemOnkos Surgical, Inc.2018-02-23
K16308140-42mm BiPolar Head and 22mm Femoral HeadSignature Orthopaedics Pty, Ltd.2018-01-29
K170072Fitmore® Hip StemZimmer GmbH2017-02-07