Data / Medical devices / United States / CPM Medical Consultants, LLC.

CPM Medical Consultants, LLC.: FDA-registered device maker in Farmers Branch, TX, United States, 8 510(k) clearances

Name: CPM Medical Consultants, LLC. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

CPM Medical Consultants, LLC. is registered with the FDA (registration 3007334927) in Farmers Branch, TX, United States. It lists 8 device types. The FDA files 8 510(k) clearances under its listings, the newest dated August 16, 2021. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 3007334927
Address: 4343 Sigma Road Suite 500, Farmers Branch, TX, United States, 75244
Owner or operator: CPM Medical (10029470)
Roles: Complaint file establishment, Specification developer
First device listed: December 3, 2018
Registered through: 2027
Brand names listed: Fuse Pedicle Screw System, Fuse ULTRA TM Foot Plating System, Maxim Surgical X-treme Interbody Fusion System, STERIZO Total Hip System, STERIZO Total Knee System, Tibial Revision Platform

Devices it lists

Device	Product code	Class	Role	Source
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	KTT	2	Complaint file establishment	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Complaint file establishment	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	LZO	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	LPH	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	JWH	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Complaint file establishment	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Complaint file establishment, Specification developer	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
August 16, 2021	K210695	CPM Medical Consultants Tibial Revision Knee System	JWH	Substantially Equivalent	Cpm Medical Consultants, LLC	accessdata.fda.gov
October 23, 2018	K182283	FUSE Pedicle Screw System	NKB	Substantially Equivalent	Black Box Medical	accessdata.fda.gov
July 27, 2016	K151424	The Progressive Orthopaedic Total Hip System	LPH	Substantially Equivalent	The Progressive Orthopaedic Company, LLC	accessdata.fda.gov
June 23, 2015	K150783	Progressive Orthopaedic Total Knee System	JWH	Substantially Equivalent	The Progressive Orthopaedic Company, LLC	accessdata.fda.gov
March 24, 2015	K142649	Progressive Orthopedic Total Knee System	JWH	Substantially Equivalent	The Progressive Orthopaedic Company, LLC	accessdata.fda.gov
February 27, 2015	K143314	Progressive Orthopaedic Total Hip System	LPH	Substantially Equivalent	The Progressive Orthopaedic Company, LLC	accessdata.fda.gov
July 23, 2014	K141784	ORTHO SOLUTIONS ULTOS PLATING SYSTEM	HRS	Substantially Equivalent	Ortho Solutions Limited	accessdata.fda.gov
February 7, 2013	K123206	MAXIM SURGICAL X-TREME INTERBODY FUSION SYSTEM	ODP	Substantially Equivalent	Maxim Surgical	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
September 17, 2025	97679	Class II	Ongoing	Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401, OS328017, OS200020L, OS200025L, OS200120L, OS200125, OS200125L, OS200135, OS200324, OS200325, OS200326, OS328026, OS328028C, OS216150, OS21	Instructions for use for a foot plating system is being updated to remove the second option of requirements for sterilization which was 3 minutes exposure time at 134-137-degrees C (273-279-degrees F) and 40mBar for 5-10 minutes drying time, because these requirements do not apply in the United States.	accessdata.fda.gov

Compare with other makers

Updated October 21, 2025. 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.