Home›USA›Biomet Orthopedics, Inc.

Biomet Orthopedics, 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

41510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 41 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

75registered devices

Class I 41Class II 34

117 including historic records

SASaudi ArabiaSFDA

43registered imported devices

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

CACanadaMDALL

36active device licences

Class II 1Class III 35

270 including historic records

TWTaiwanTFDA

14valid device licences

Class I 2Class II 12

SGSingaporeHSA SMDR

23device registrations

CLASS B 6CLASS C 17

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

337active ARTG entries

Class I 135Class III 149IIa 26IIb 23Class Im (measuring) 2Class Is (sterile) 2

HKHong KongMDACS

8valid listings

Class II 1Class III 7

ILIsraelAMAR

19registrations

RURussiaRoszdravnadzor

10active registrations

Class 1 6Class 2a 1Class 2b 3

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 States0 registration records, 41 510(k), 0 PMA, 53 excluded

Brazil75 confirmed, 27 excluded

Saudi Arabia43 confirmed, 6 excluded

Canada36 confirmed, 13 excluded

Manufacturer names merged into this page: BIOMET ORTHOPEDICS, ATA BIOMET SPORTS MEDICINE, ATA BIOMET BIOLOGICS, ATA BIOMET TRAUMA · BIOMET SPAIN ORTHOPEDICS S.L. · BIOMET ORTHOPEDICS · BIOMET ORTHOPEDICS INC. · BIOMET ORTHOPEDICS/ BIOMET UK · Biomet Orthopedics

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252404	Comprehensive Reverse Shoulder - HA Glenosphere Baseplates	2026-04-15
US	K243761	A.L.P.S. Small Fragment Plating System	2025-02-19
US	K223631	Comprehensive Segmental Revision System(SRS)	2023-07-12
BR	80044689002	INSTRUMENTAIS PARA CIRURGIA DE JOELHO BIOMET®	Class I
BR	80044680051	INSTRUMENTAIS NÃO-ESTÉREIS, NÃO-ARTICULADOS E CORTANTES PARA ARTROSCOP	Class II
BR	80044689009	INSTRUMENTAIS PARA CIRURGIA DE QUADRIL	Class I
SA	ME0000007331SFDAA00001	Hip Arthroscopy Instrument Case	—
SA	ME0000007333SFDAA00001	JuggerKnot Long Hip Arthroscopy Instrument Caddy	—
CA	1012	ASCENT KNEE PROSTHESIS	Class III
CA	3083	REPICCI II UNICONDYLAR KNEE	Class III
CA	11838	AGC MOLDED TIBIAL COMPONENT	Class III

Biomet Orthopedics, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

Similar companies