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Mako Surgical Corporation

USA · Weston

✓ 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

21listed device types

Class I 10Class II 11Class III 0

plus 44 registration records and 42 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class I 4Class II 2

9 including historic records

SASaudi ArabiaSFDA

3registered imported devices

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

CACanadaMDALL

10active device licences

Class II 8Class III 2

23 including historic records

TWTaiwanTFDA

10valid device licences

Class I 3Class II 7

SGSingaporeHSA SMDR

3device registrations

CLASS B 1CLASS C 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

52active ARTG entries

Class I 17Class III 6IIa 24Class Im (measuring) 1Class Is (sterile) 4

HKHong KongMDACS

4valid listings

Class II 3Class III 1

ILIsraelAMAR

9registrations

RURussiaRoszdravnadzor

4active registrations

Class 2a 3Class 2b 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 States44 registration records, 42 510(k), 0 PMA

Brazil6 confirmed, 0 excluded

Saudi Arabia3 confirmed, 0 excluded

Canada10 confirmed, 0 excluded

Manufacturer names merged into this page: MAKO SURGICAL CORP. · MAKO SURGICAL CORP (WESTON-FL) · Mako Surgical Corp.

FDA 510(k) clearances by year

22005

12006

12007

72008

32009

12010

22012

12013

22014

62015

62017

12019

22020

22022

22024

22025

12026

FDA listed device types

showing 8 of 21

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer 1Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer 1Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer 1Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer 1Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer 1Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer 1Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented 1Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260222	Mako Total Knee Application	2026-02-25
US	K250608	Mako Total Knee Application (3.0); Hybrid Tip Pointer	2025-04-25
US	K243751	Mako Total Hip Application 5.0	2025-03-05
BR	80005439025	SISTEMA MAKO	Class II
BR	80005430439	Instrumental Não Articulado e Não cortante em Cromo Cobalto Stryker	Class I
BR	80005430543	INSTRUMENTAL EM PPSU STRYKER	Class I
SA	ME0000005424SFDAA00050	CREST DRILL GUIDE	—
SA	ME0000005424SFDAA00051	CREST PIN CLAMP	—
CA	85080	RIO (ROBOTIC ARM INTERACTIVE ORTHOPEDIC) SYSTEM	Class III
CA	86223	REAMERS	Class II
CA	87502	RESTORIS MCK UNI INSTRUMENT SET	Class II