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MAKO SURGICAL CORP (WESTON-FL)

USA

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 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

MAKO SURGICAL CORP (WESTON-FL)

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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