FDA.reportPublic FDA data

510(k) K254154

Device
FX V135 EASYTECH® Shoulder System
Applicant
FX Shoulder Solutions, Inc.
510(k) number
K254154
Product code
PKC
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-01
Date received
2025-12-22
Regulation
888.3660
Classification name
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Cory Trier
Address
15920 Addison Rd. Suite 200 Addison TX US 75001 75001

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PKC#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.2025-10-03
K243248INHANCE INTACT™Depuy Ireland UC2024-12-23
K241873OsseoFit Stemless Shoulder SystemZimmer, Inc.2024-12-11
K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.2024-11-20
K221758SMR Stemless AnatomicLima Corporate S.P.A.2023-03-17
K220418Tornier Perform Humeral System – StemlessTornier, Inc.2022-09-14
K213615Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.2022-03-11
K212683GLOBAL ICON Stemless Shoulder SystemDepuy(Ireland)2022-01-19
K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC2021-07-16
K201391Easytech® Anatomical Shoulder SystemFx Shoulder USA, Inc.2021-02-16
K203100Arthrex Eclipse Titanium Humeral HeadArthrex, Inc.2020-11-20
K201542Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc.2020-07-08
K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.2020-06-03
K192097Exactech® Equinoxe® Stemless Humeral ComponentsExactech, Inc.2020-04-29
K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp2019-04-22