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ConforMIS, Inc.

USA · Wilmington

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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

12listed device types

Class I 1Class II 11Class III 0

plus 38 registration records and 60 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 2Class II 1

4 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

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 States38 registration records, 60 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Manufacturer names merged into this page: ConforMIS, Inc. · CONFORMIS, INC

FDA 510(k) clearances by year

12005

22006

32007

12008

22009

12010

32011

62012

42013

62014

12015

52016

22017

12018

32019

42020

62021

32022

62023

FDA listed device types

showing 8 of 12

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer 1Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented 1Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer 1Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer 1Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented 1Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate 1Knee Arthroplasty Implantation System 1Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K232426	Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts	2023-09-08
US	K223316	Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System	2023-07-21
US	K230846	iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System	2023-07-17
BR	81335019001	Instrumentais iJig iTotal Conformis	Class II
BR	81335010004	Instrumentais Reutilizáveis Conformis® iTotal	Class I
BR	81335010002	Instrumentais Reutilizáveis ConforMIS® iTotal	Class I

ConforMIS, Inc.

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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