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Medtronic Powered Surgical Solutions: FDA-registered device maker in Fort Worth, TX, United States, 21 510(k) clearances

Name: Medtronic Powered Surgical Solutions FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Medtronic Powered Surgical Solutions is registered with the FDA (registration 1625507) in Fort Worth, TX, United States. It lists 16 device types. The FDA files 21 510(k) clearances under its listings, the newest dated February 12, 2026. 11 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 1625507
Address: 4620 North Beach ST., Fort Worth, TX, United States, 76137
Owner or operator: Medtronic, Inc. (2112641)
Roles: Manufacturer, Specification developer
First device listed: February 6, 1996
Registered through: 2027
Brand names listed: AEX Generator Refurbished, Bone Mill, Clearview Surgical Dissecting Tools, Cooling Tubing Sets, Cranial/Ortho/Neuro Elec Drill Sys, ENT Drill & Handpiece, elec & pneu, Foot Control, IPC - Integrated Power Console Drill System and more

Devices it lists

Device	Product code	Class	Role	Source
Arthroscope	HRX	2	Manufacturer, Specification developer	accessdata.fda.gov
Blade, Saw, Surgical, Cardiovascular	DWH	1	Manufacturer	accessdata.fda.gov
Bone Mill	LYS	1	Manufacturer	accessdata.fda.gov
Bur, Ear, Nose And Throat	EQJ	1	Manufacturer, Specification developer	accessdata.fda.gov
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	ERL	2	Manufacturer, Specification developer	accessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Simple, Powered)	HBE	2	Manufacturer, Specification developer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	1	Manufacturer, Specification developer	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment	HSZ	1	Manufacturer	accessdata.fda.gov
Motor, Drill, Electric	HBC	2	Manufacturer, Specification developer	accessdata.fda.gov
Motor, Drill, Pneumatic	HBB	2	Manufacturer	accessdata.fda.gov
Motor, Surgical Instrument, Pneumatic Powered	GET	1	Manufacturer	accessdata.fda.gov
Neurological Stereotaxic Instrument	HAW	2	Manufacturer	accessdata.fda.gov
Orthopedic Stereotaxic Instrument	OLO	2	Manufacturer	accessdata.fda.gov
Parathyroid Autofluorescence Detection Device	QDF	2	Manufacturer	accessdata.fda.gov
Saw, Pneumatically Powered	KFK	1	Manufacturer, 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
February 12, 2026	K253381	Stealth AXiS Surgical System with Stealth AXiS Spine clinical application	OLO	Substantially Equivalent	Medtronic Navigation, Inc.	accessdata.fda.gov
November 23, 2021	K213454	Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm	HBE	Substantially Equivalent	Medtronic Powered Surgical Solutions	accessdata.fda.gov
November 2, 2020	K202552	Midas Rex Attachments and Dissecting Tools	OLO	Substantially Equivalent	Medtronic Powered Surgical Solutions (Mpss)	accessdata.fda.gov
November 1, 2019	K191597	Stealth Autoguide System, Midas Rex Legend Depth Stop System	HAW	Substantially Equivalent	Medtronic Navigation, Inc.	accessdata.fda.gov
May 22, 2019	K183644	Stealth-Midas MR8 System	OLO	Substantially Equivalent	Medtronic Powered Surgical Solutions	accessdata.fda.gov
May 12, 2019	K183515	MR8 Drill System, Midas Rex MR8 ClearView Tools	HBC	Substantially Equivalent	Medtronic Powered Surgical Solutions	accessdata.fda.gov
November 2, 2018	DEN170056	Parathyroid Detection (Model PTeye) System	QDF	Unknown	Aibiomed, Corp.	accessdata.fda.gov
May 15, 2017	K170312	IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools	HBC	Substantially Equivalent	Medtronic Powered Surgical Solutions	accessdata.fda.gov
March 28, 2017	K163565	MR8 Drill System	HBC	Substantially Equivalent	Medtronic Powered Surgical Solutions	accessdata.fda.gov
March 23, 2017	K163182	Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories	HBB	Substantially Equivalent	Medtronic Powered Surgical Solutions	accessdata.fda.gov
May 26, 2016	K160713	Stealth-Midas System	OLO	Substantially Equivalent	Medtronic Powered Surgical Solutions	accessdata.fda.gov
December 31, 2014	K143175	AEx Generator; PlasmaBlade T	GEI	Substantially Equivalent	Medtronic Advanced Energy	accessdata.fda.gov
August 27, 2012	K121264	TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE	HBE	Substantially Equivalent	Medtronic Surgical Technologies	accessdata.fda.gov
March 26, 2009	K090112	MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700	HBB	Substantially Equivalent	Medtronic Powered Surgical Solutions	accessdata.fda.gov
October 17, 2008	K081475	ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)]	HBE	Substantially Equivalent	Medtronic Xomed, Inc.	accessdata.fda.gov
September 5, 2008	K081277	XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC)	ERL	Substantially Equivalent	Medtronic Xomed, Inc.	accessdata.fda.gov
September 18, 2007	K072315	MIDAS REX CURVED BUR	HBE	Substantially Equivalent	Medtronic Powered Surgical Solutions	accessdata.fda.gov
March 18, 2002	K020069	MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM	HBB	Substantially Equivalent	Medtronic Midas Rex	accessdata.fda.gov
October 22, 2001	K012453	SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY)	HBC	Substantially Equivalent	Sodemsystems	accessdata.fda.gov
May 7, 1990	K900388	MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINES	HBE	Substantially Equivalent	Midas Rex Pneumatic Tools, Inc.	accessdata.fda.gov
February 24, 1987	K870157	OSCILLATING SAW/ RECIPROCATING SAW/ DRILL-REAMER	KFK	Substantially Equivalent	Micro-Aire Surgical Instruments, Inc.	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
May 13, 2016	74275	Class II	Terminated	Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Number: ES310; Saw Saggital, Finger Refurbished Catalog Number: ES310-R; Used to dissect bone in surgica	Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm Seal identified a potential for leakage of fluid into the motor during use.	accessdata.fda.gov
April 8, 2016	73869	Class II	Terminated	Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.	Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.	accessdata.fda.gov
October 21, 2015	72541	Class II	Terminated	Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes.	The wire pass hole is not present on the tools.	accessdata.fda.gov
November 30, 2009	53996	Not yet classified	Terminated	Medtronic Midas Rex Legend Footed Attachment, AF01. Intended for use with all Legend and Legend EHS motors for general surgery including maxillofacial, craniofacial and sternotomy applications.	Component of product attachment may be outside established tolerance with potential for footed portion to break during normal use.	accessdata.fda.gov
May 30, 2008	48472	Not yet classified	Terminated	Medtronic Midas Rex Legend tapered dissecting tool, Model F2/8TA23 Medtronic Powered Surgical Solutions, Forth Worth, TX Intended for use in Spinal, Cranial, Orthopedic, General Surgical and Plastic Surgery applications	Cutting flute geometry of surgical dissecting tools may be outside of established tolerance. This may lead to reduced cutting performance, inability to perform desired dissection, increased risk of overheating, and potential need for revision surgery.	accessdata.fda.gov
September 1, 2005	33340	Not yet classified	Terminated	Medtronic Midas Rex Classic, GS and Legend dissecting tools manufactured by Medtronic Inc. Powered Surgical Solutions, 4620 North Beach Street, Fort Worth, tX 76137 USA, Rx only, Sterile, Single Use Only.	Potential compromise of sterile packaging for disposable dissecting tools.	accessdata.fda.gov
June 29, 2005	32560	Not yet classified	Terminated	Medtronic MIDAS REX Legend High Speed Pneumatic System, Gold Touch Motor. Manufactured by Medtronic, Inc. Powered Surgical Solutions, 4620 North Beach Street, Fort Worth, TX 76137.	Complaints of finger control component breaking off and falling into open surgical wound.	accessdata.fda.gov
January 3, 2005	30904	Not yet classified	Terminated	Medtronic Midas Rex Legacy Telescoping Dissection Tool, Model TDQ-130D, manufactured by Medtronic Powered Surgical Solutions, Fort Worth, Texas 76137	Device is missing the sub-collet component within the dissecting tool package.	accessdata.fda.gov
November 11, 2004	30509	Not yet classified	Terminated	Medtronic Midas Rex Legend High Speed Pneumatic System	Softer hose increases the propensity for outer exhaust hose to kink or become occluded as a result of clamping. Complaints of hose rupture/burst have been reported.	accessdata.fda.gov
November 3, 2004	30385	Not yet classified	Terminated	Medtronic Midas Rex Legend Lubricant/ Diffuser Cartridge Catalog number PA100-A, manufactured by Medtronic Powered Surgical Solutions, Fort Worth, Texas	Reduced plastic thickness of lubricant/diffuser cartidge can crack under pressure causing leakage of lubricant as visible mist (appearance of smoke).	accessdata.fda.gov
November 11, 2002	25019	Not yet classified	Terminated	Legend Lubricant System (Legend Gold, Gold Touch and Platinum motors and Legend Lubricant/Diffuser cartridge)	Lubricant leaking from motor after sterilization causing bleed-through sterilization wrap and/or excess lubricant in instrument case.	accessdata.fda.gov

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Updated February 12, 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.