ClearanceBrief
Company · US

Fx Shoulder USA, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2024. Name variants (Inc, Corp, punctuation) are merged.

11510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)

Product codes

CodeDeviceRecords
PHXShoulder Prosthesis, Reverse Configuration10
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented1
PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
May 15, 2024K240278Full Wedge Lateralized and Augmented Baseplates
Fx Shoulder USA, Inc.
PHX
Jun 5, 2023K223801FX V135(TM) Shoulder Prosthesis
Fx Shoulder USA, Inc.
PHX
Nov 7, 2022K222936Humeris® 135 Shoulder System
Fx Shoulder USA, Inc.
PHX
Jun 7, 2022K213117FX V135 Shoulder Prosthesis
Fx Shoulder USA, Inc.
PHX
Aug 25, 2021K210790Lateralized and Augmented Baseplates
Fx Shoulder USA, Inc.
PHX
Feb 16, 2021K201391Easytech® Anatomical Shoulder System
Fx Shoulder USA, Inc.
PKC
Jul 16, 2020K191698TiN Coated Humeral Head
Fx Shoulder USA, Inc.
KWT
Jul 15, 2020K191146Humelock TiN Coated Glenosphere
Fx Shoulder USA, Inc.
PHX
Apr 29, 2020K193394Humeral Cup Stability & Humeral Cup 135/145o Stability
Fx Shoulder USA, Inc.
PHX
Feb 21, 2020K192799Glenoid Baseplate with Screw
Fx Shoulder USA, Inc.
PHX
Oct 8, 2019K19220632mm Glenosphere and Humeral Cup
Fx Shoulder USA, Inc.
PHX

Latest recalls

DateFirm and productCodeLinked 510(k)
Jan 29, 2024FX SHOULDER
Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
Open, Classified		 PHXK191146
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