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Maxx Orthopedics, Inc.

USA · Norristown

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, Australia, Hong Kong, Russia — 7 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

30listed device types

Class I 19Class II 11Class III 0

plus 45 registration records and 25 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

2 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

20active ARTG entries

Class III 20

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

2active registrations

Class 1 1Class 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 States45 registration records, 25 510(k), 0 PMA, 1 excluded

Brazil0 confirmed, 1 excluded

Manufacturer names merged into this page: MAXX ORTHOPEDICS INC.

FDA 510(k) clearances by year

10020

32009

12012

12014

12015

12018

42019

22020

22024

72025

22026

FDA listed device types

showing 8 of 30

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, 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 1Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate 1Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261563	Freedom Total Knee System (E-Poly Tibial Liners)	2026-08-07
US	K253171	Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)	2026-01-15
US	K252777	Freedom Metaphyseal Cone Implants (Metaphyseal Cones)	2025-10-31

Maxx Orthopedics, 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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