Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
510(k) Number K254154
Device Name FX V135 EASYTECH® Shoulder System
Applicant
FX Shoulder Solutions, Inc.
15920 Addison Rd.
Suite 200
Addison,  TX  75001
Applicant Contact Cory Trier
Correspondent
FX Shoulder Solutions, Inc.
15920 Addison Rd.
Suite 200
Addison,  TX  75001
Correspondent Contact Cory Trier
Regulation Number888.3660
Classification Product Code
PKC  
Subsequent Product Codes
HSD   KWT   PHX  
Date Received12/22/2025
Decision Date 05/01/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-