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DEPUY ORTHOPAEDICS, INC.

USA · Warsaw

✓ 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

222listed device types

Class I 104Class II 111Class III 7

plus 769 registration records and 215 510(k), 152 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

22registered devices

Class I 17Class II 5

41 including historic records

SASaudi ArabiaSFDA

179registered imported devices

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

CACanadaMDALL

26active device licences

Class III 26

105 including historic records

TWTaiwanTFDA

4valid device licences

Class I 1Class II 3

SGSingaporeHSA SMDR

3device registrations

CLASS C 3

KRSouth KoreaMFDS GMP

7GMP quality-system certificates

Import 7

AUAustraliaTGA ARTG

185active ARTG entries

Class I 95Class III 55IIa 18IIb 11Class Im (measuring) 2Class Is (sterile) 4

HKHong KongMDACS

11valid listings

Class II 1Class III 10

ILIsraelAMAR

12registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 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 States769 registration records, 215 510(k), 152 PMA, 41 excluded

Brazil22 confirmed, 13 excluded

Saudi Arabia179 confirmed, 5 excluded

Canada26 confirmed, 8 excluded

Manufacturer names merged into this page: DEPUY ORTHOPAEDICS · DEPUY ORTHOPAEDICS, INC. · DEPUY ORTHOPAEDICS INC · DePuy Orthopaedics, Inc. · DePuy Orthopaedics, lnc

FDA 510(k) clearances by year

102005

202006

212007

162008

142009

82010

82011

22012

22013

12014

12015

12017

32018

52019

52020

12021

12022

12023

12024

12026

FDA listed device types

showing 8 of 222

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Electrosurgical, Cutting & Coagulation & Accessories 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer 1Cerclage, Fixation 1Neurosurgical Nerve Locator 1Washer, Bolt Nut 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252887	DePuy ATTUNE Knee System	2026-05-22
US	K242665	DePuy ATTUNE Total Knee System	2024-11-01
US	K231503	CUPTIMIZE Advanced	2023-08-22
BR	10132590285	INSTRUMENTOS P.F.C* E SPECIALIST*	Class I
BR	80145901861	Instrumentais Actis	Class I
BR	10132590627	KIT INSTRUMENTAL PARA PROTESE MODULAR DE QUADRILC-STEM*	Class I
SA	ME0000003224SFDAA00504	TRI-LOCK BPS w/GRIPTION BROACH	—
SA	ME0000000720SFDAA00127	SIG HP FEMORAL TRIALS CASE	—
CA	9731	PROFILE HIP STEM WITH POROCOAT	Class III
CA	2277	ENDURANCE ALL-POLYETHYLENE ACETABULAR CUP	Class III
CA	2372	ROBERT BRIGHAM UNICONDLYAR KNEE	Class III