Home›USA›Arthrex, Inc.

Arthrex, Inc.

USA · Naples

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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

124listed device types

Class I 63Class II 59Class III 0unclassified 2

plus 1,006 registration records and 352 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

164registered devices

Class I 49Class II 115

241 including historic records

SASaudi ArabiaSFDA

332registered imported devices

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

CACanadaMDALL

24active device licences

Class II 20Class III 4

223 including historic records

TWTaiwanTFDA

22valid device licences

Class I 5Class II 17

SGSingaporeHSA SMDR

141device registrations

CLASS B 55CLASS C 67CLASS D 19

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

Import 4

AUAustraliaTGA ARTG

317active ARTG entries

Class I 100Class III 47IIa 103IIb 41Class Im (measuring) 15Class Is (sterile) 11

HKHong KongMDACS

3valid listings

Class II 1Class IV 2

ILIsraelAMAR

11registrations

RURussiaRoszdravnadzor

27active registrations

Class 1 4Class 2a 18Class 2b 4Class 3 1

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 States1,006 registration records, 352 510(k), 0 PMA, 17 excluded

Brazil164 confirmed, 2 excluded

Saudi Arabia332 confirmed, 0 excluded

Canada24 confirmed, 1 excluded

Manufacturer names merged into this page: Arthrex, Inc. · ARTHREX, INC. · Arthrex GmbH · ARTHREX GMBH · ARTHREX INC · ARTHREX INC.

FDA 510(k) clearances by year

82007

42008

62009

62010

112011

72012

102013

122014

132015

112016

102017

162018

192019

262020

112021

172022

182023

102024

212025

142026

FDA listed device types

showing 8 of 124

Electrosurgical, Cutting & Coagulation & Accessories 1Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Rod, Fixation, Intramedullary And Accessories 1Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon 1Cerclage, Fixation 1Drape, Surgical, Exempt 1System, Suction, Lipoplasty For Removal 1Bone Wedge 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K262357	Arthrex Bioabsorbable PushLock Suture Anchors	2026-08-07
US	K260624	Arthrex Radial Head Replacement System	2026-07-30
US	K260018	Arthrex FiberButton	2026-06-26
BR	80978569045	Sistema Synergy Shaver & Power	Class II
BR	80978569042	Lâminas Synergy Shaver & Power	Class II
BR	80978569043	Kit descartável para Swivelock DX 3.5 x 13.5mm	Class II
SA	ME0000004766SFDAA00002	Punch, WideBiter™ 15° Up Tip, Ø3.4 mm 15° Up Curved Shaft with FlushPo	—
SA	ME0000004766SFDAA00007	Curette, Both Sides Cut, Dia 5.4mm Ring, 220 mm	—
CA	83257	ARTHROSCOPY TROCARS & OBTURATORS	Class II
CA	83259	ARTHROSCOPY SHEATHS	Class II
CA	84626	IMAGE CAPTURE DEVICE	Class II