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Home›USA›Fx Shoulder USA, Inc.

Fx Shoulder USA, Inc.

USA · Dallas
✓ 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
9listed device types
Class I 1Class II 8Class III 0
plus 27 registration records and 12 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class I 2
this export covers Class I / II only (the cadastro route)
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 States27 registration records, 12 510(k), 0 PMA, 4 excluded
Brazil2 confirmed, 0 excluded
Manufacturer names merged into this page: Fx Shoulder Solutions SAS · Fx Shoulder Solutions Inc. · FX SHOULDER SOLUTIONS
Same-named companies — This database also contains companies with near-identical names: FX Shoulder Solutions, Inc., Fx Solutions. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Dallas

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12019
42020
22021
22022
12023
12024
12026

FDA listed device types

showing 8 of 9
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented 1Rod, Fixation, Intramedullary And Accessories 1Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained 1Plate, Fixation, Bone 1Suture, Nonabsorbable, Synthetic, Polyethylene 1Screw, Fixation, Bone 1Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented 1Shoulder Prosthesis, Reverse Configuration 1

Registration details (sample)

MarketIdentifierNameClass / date
USK254154FX V135 EASYTECH® Shoulder System2026-05-01
USK240278Full Wedge Lateralized and Augmented Baseplates2024-05-15
USK223801FX V135(TM) Shoulder Prosthesis2023-06-05
BR80537060015KIT INSTRUMENTAL PARA OMBRO FX V135Class I
BR80537060016KIT INSTRUMENTAL PARA OMBRO EASYTECHClass I

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