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ARTHROSURFACE, INC.

USA · Franklin

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia, Israel — 6 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

pendingnot queried

USUnited StatesFDA openFDA

18listed device types

Class I 2Class II 13Class III 2unclassified 1

plus 31 registration records and 26 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

10 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

Class I 1IIa 1Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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.

United States31 registration records, 26 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: ARTHROSURFACE, INC.

FDA 510(k) clearances by year

12004

12005

12006

22007

12009

22012

22013

52014

22016

42017

22018

12019

12020

12021

FDA listed device types

showing 8 of 18

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented 1Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer 1Prosthesis, Toe, Hemi-, Phalangeal 1Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer 1Plate, Fixation, Bone 1Screw, Fixation, Bone 1Prosthesis, Hip, Femoral, Resurfacing 1Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K203375	OVOMotion Reverse Shoulder Arthroplasty System	2021-06-24
US	K200718	Arthrosurface WristMotion Total Wrist Arthroplasty System	2020-10-15
US	K190261	BOSS Toe Fixation System	2019-08-14
BR	80454389004	Chave de Aplicação Fio Guia Pleuristik NanoFx	Class I

ARTHROSURFACE, INC.

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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