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Fx Shoulder Solutions SAS: FDA-registered device maker in Viriat Auvergne-Rhone-Alpes, France, 22 510(k) clearances

Name: Fx Shoulder Solutions SAS FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Fx Shoulder Solutions SAS is registered with the FDA (registration 3009532798) in Viriat Auvergne-Rhone-Alpes, France. It lists 9 device types. The FDA files 22 510(k) clearances under its listings, the newest dated May 1, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009532798
Address: 1663 rue de Majornas, Viriat Auvergne-Rhone-Alpes, France, 01440
Owner or operator: FX Shoulder Solutions (10039598)
Roles: Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
First device listed: January 26, 2012
Registered through: 2026
Brand names listed: 32mm Glenosphere and Humeral Cup, Easytech® Anatomical Shoulder System, FX SOLUTIONS, FX V135 Easytech, FX V135 Shoulder Prosthesis, Flexnail, Full Wedge Lateralized and Augmented Baseplates, HUMELOCK and more

Devices it lists

Device	Product code	Class	Role	Source
Orthopedic Manual Surgical Instrument	LXH	1	Manufacturer, Specification developer	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Manufacturer, Specification developer	accessdata.fda.gov
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	HSD	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	KWT	2	Manufacturer, Specification developer	accessdata.fda.gov
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	PKC	2	Manufacturer	accessdata.fda.gov
Rod, Fixation, Intramedullary And Accessories	HSB	2	Specification developer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Manufacturer, Specification developer	accessdata.fda.gov
Shoulder Prosthesis, Reverse Configuration	PHX	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	2	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 1, 2026	K254154	FX V135 EASYTECH® Shoulder System	PKC	Substantially Equivalent	FX Shoulder Solutions, Inc.	accessdata.fda.gov
May 15, 2024	K240278	Full Wedge Lateralized and Augmented Baseplates	PHX	Substantially Equivalent	Fx Shoulder USA, Inc.	accessdata.fda.gov
June 5, 2023	K223801	FX V135(TM) Shoulder Prosthesis	PHX	Substantially Equivalent	Fx Shoulder USA, Inc.	accessdata.fda.gov
November 7, 2022	K222936	Humeris® 135 Shoulder System	PHX	Substantially Equivalent	Fx Shoulder USA, Inc.	accessdata.fda.gov
June 7, 2022	K213117	FX V135 Shoulder Prosthesis	PHX	Substantially Equivalent	Fx Shoulder USA, Inc.	accessdata.fda.gov
August 25, 2021	K210790	Lateralized and Augmented Baseplates	PHX	Substantially Equivalent	Fx Shoulder USA, Inc.	accessdata.fda.gov
February 16, 2021	K201391	Easytech® Anatomical Shoulder System	PKC	Substantially Equivalent	Fx Shoulder USA, Inc.	accessdata.fda.gov
July 16, 2020	K191698	TiN Coated Humeral Head	KWT	Substantially Equivalent	Fx Shoulder USA, Inc.	accessdata.fda.gov
July 15, 2020	K191146	Humelock TiN Coated Glenosphere	PHX	Substantially Equivalent	Fx Shoulder USA, Inc.	accessdata.fda.gov
April 29, 2020	K193394	Humeral Cup Stability & Humeral Cup 135/145o Stability	PHX	Substantially Equivalent	Fx Shoulder USA, Inc.	accessdata.fda.gov
February 21, 2020	K192799	Glenoid Baseplate with Screw	PHX	Substantially Equivalent	Fx Shoulder USA, Inc.	accessdata.fda.gov
October 8, 2019	K192206	32mm Glenosphere and Humeral Cup	PHX	Substantially Equivalent	Fx Shoulder USA, Inc.	accessdata.fda.gov
May 17, 2017	K163669	Humeris Shoulder	PHX	Substantially Equivalent	Fx Solutions	accessdata.fda.gov
January 17, 2017	K162455	Humelock Reversed Shoulder	PHX	Substantially Equivalent	Fx Solutions	accessdata.fda.gov
November 13, 2015	K150488	Humelock II Reversible Shoulder System	PHX	Substantially Equivalent	Fx Solutions	accessdata.fda.gov
August 27, 2015	K143721	PRCT2	HRS	Substantially Equivalent	Fx Solutions	accessdata.fda.gov
July 28, 2014	K140071	HUMELOCK II CEMENTED SHOULDER SYSTEM	KWT	Substantially Equivalent	Fx Solutions	accessdata.fda.gov
November 9, 2013	K130759	HUMELOCK II CEMENTLESS SHOULDER SYSTEM	HSD	Substantially Equivalent	Fx Solutions	accessdata.fda.gov
August 13, 2013	K123814	HUMELOCK II CEMENTED SHOULDER SYSTEM	KWT	Substantially Equivalent	Fx Solutions	accessdata.fda.gov
November 9, 2011	K111097	HUMELOCK CEMENTED SHOULDER PROSTHESIS	HSD	Substantially Equivalent	Fx Solutions	accessdata.fda.gov
June 18, 2003	K023030	DEMETECH POLYESTER NONABSORBABLE SUTURE	GAT	Substantially Equivalent	Demetech Corp.	accessdata.fda.gov
December 5, 1996	K964243	HUMERUS WIRES	HSB	Substantially Equivalent	Compagnie Financiere & Medicale (Cf&M)	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
June 4, 2018	80302	Class II	Terminated	Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiati	Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19.	accessdata.fda.gov

Compare with other makers

Updated May 1, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.