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b-ONE Ortho Corp.

USA · Fairfield NJ · www.b1.co

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Singapore, Hong Kong — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

0UDI-DI device records

USUnited StatesFDA openFDA

24listed device types

Class I 17Class II 7Class III 0

plus 56 registration records and 13 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

14registered devices

Class I 2Class II 12

15 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

2device registrations

CLASS C 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

2valid listings

Class III 2

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union31,104 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified

United States56 registration records, 13 510(k), 0 PMA, 59 excluded

United Kingdom0 confirmed, 123 excluded

Brazil14 confirmed, 16 excluded

Saudi Arabia0 confirmed, 3 excluded

Canada0 confirmed, 8 excluded

Manufacturer names merged into this page: b-ONE Ortho Corp. · B-ONE ORTHO, CORP.

FDA 510(k) clearances by year

22018

22019

12020

32021

22022

12024

22026

FDA listed device types

showing 8 of 24

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer 1Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented 1Screw, Fixation, Bone 1Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate 1Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive 1Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented 1Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented 1Screwdriver 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261352	2D Hip Planning Software	2026-06-08
US	K253357	b-ONE® Bipolar Head	2026-04-13
US	K240528	b-ONE® Total Hip System	2024-11-15
BR	80769979019	Broca b-ONE para Artroplastia Total de Quadril	Class II
BR	80769979020	Instrumental para Artroplastia Total de Quadril b-ONE	Class II
BR	80769979021	Instrumental para Artroplastia Total de Quadril b-ONE - PPSU	Class II

b-ONE Ortho Corp.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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