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HOWMEDICA OSTEONICS CORP./STRYKER ORTHOPAEDICS

USA

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Israel — 5 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

64listed device types

Class I 20Class II 40Class III 4

plus 284 registration records and 349 510(k), 31 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

50registered devices

Class I 36Class II 14

86 including historic records

SASaudi ArabiaSFDA

149registered imported devices

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

CACanadaMDALL

71active device licences

Class II 6Class III 65

221 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 States284 registration records, 349 510(k), 31 PMA, 5 excluded

Brazil50 confirmed, 1 excluded

Saudi Arabia149 confirmed, 0 excluded

Canada71 confirmed, 1 excluded

Manufacturer names merged into this page: HOWMEDICA OSTEONICS CORP · HOWMEDICA OSTEONICS CORPORATION · HOWMEDICA OSTEONICS CORP. · HOWMEDICA OSTEONICS STRYKER IRELAND · HOWMEDICA OSTEONICS CORP./STRYKER ORTHOPAEDICS · Howmedica Osteonics Corp.

Same-named companies — This database also contains companies with near-identical names: HOWMEDICA OSTEONICS CORPORATION, Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics, Howmedica Osteonics Corp., Dba Stryker Orthopaedics, HOWMEDICA OSTEONICS STRYKER IRELAND. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

272005

232006

182007

122008

92009

112010

92011

62012

52013

12016

22017

12018

42019

62020

32021

52022

62023

52024

62025

32026

FDA listed device types

showing 8 of 64

Rod, Fixation, Intramedullary And Accessories 1Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer 1Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer 1Cerclage, Fixation 1Screw, Fixation, Bone 1Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate 1Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented 1Cement Obturator 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261898	Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System	2026-08-06
US	K261624	Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component	2026-07-10
US	K253637	Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert	2026-02-18
BR	80005430392	Instrumental Stryker não Articulado não Cortante Orthopaedics	Class I
BR	80005430197	INSTRUMENTAL PARA CIRURGIA DE QUADRIL III	Class I
BR	80005430069	SISTEMA INSTRUMENTAL STRYKER EXETER PARA ATQ	Class I
SA	ME0000005423SFDAA00346	RESTORATION ® MODULAR PROXIMAL CONE REAMERS TRAY (19mm - 31mm)	—
SA	ME0000005423SFDAA00342	Modular Rotating Hinge Knee IM Reamer Depth Stop Offet Femur Stem 155m	—
CA	2278	MODULAR REPLACEMENT SYSTEM - HUMERAL COMPONENTS	Class III
CA	4219	WICHITA FUSION NAIL	Class III
CA	6224	DURACON UNICOMPARTMENTAL KNEE SYSTEM	Class III

HOWMEDICA OSTEONICS CORP./STRYKER ORTHOPAEDICS

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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