Medtronic Powered Surgical Solutions

Fort Worth, TX, US

MEDTRONIC POWERED SURGICAL SOLUTIONS appears in FDA device records in Fort Worth, TX. FDA records list 9 510(k) clearances between 2007-09-18 and 2021-11-23, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 11 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 9
PMA records: 0
Recall records: 11
Registered establishments: 1

FDA records under these names

3 names

FDA records resolved to Medtronic Powered Surgical Solutions carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Medtronic Sofamor Danek Usa, Inc - Dallas Distributionenforcement report, recall
Medtronics Midas Rexrecall
Power Surgical Solutionsrecall

510(k) clearance history

FDA records hold 9 510(k) clearances for Medtronic Powered Surgical Solutions between 2007 and 2021. The busiest year on record is 2017, with 3. The most recent is 2021, with 1.

Clearances by year, as a table

510(k) clearance decisions for Medtronic Powered Surgical Solutions, by decision year
Year	Clearances
2007	1
2009	1
2016	1
2017	3
2019	2
2021	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
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	2021-11-23
K183644	Stealth-Midas MR8 System	OLO	Substantially Equivalent	2019-05-22
K183515	MR8 Drill System, Midas Rex MR8 ClearView Tools	HBC	Substantially Equivalent	2019-05-12
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	2017-05-15
K163565	MR8 Drill System	HBC	Substantially Equivalent	2017-03-28
K163182	Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories	HBB	Substantially Equivalent	2017-03-23
K160713	Stealth-Midas System	OLO	Substantially Equivalent	2016-05-26
K090112	MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700	HBB	Substantially Equivalent	2009-03-26
K072315	MIDAS REX CURVED BUR	HBE	Substantially Equivalent	2007-09-18

Registered establishments

FDA registered establishments for Medtronic Powered Surgical Solutions, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
1625507	1625507	MEDTRONIC POWERED SURGICAL SOLUTIONS	4620 NORTH BEACH ST., FORT WORTH, TX 76137 US	2026	DWH EQJ ERL GEI GET HAW HBB HBC HBE HRX and 6 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2085-2016	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 surgical applications.	Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm Seal identified a potential for leakage of fluid into the motor during use.	Class II	2016-05-13	Terminated
Z-1602-2016	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.	Class II	2016-04-08	Terminated
Z-0321-2016	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.	Class II	2015-10-21	Terminated
Z-0546-2010	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.		2009-11-30	Terminated
Z-2156-2008	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 for transection, osteotomy, graft harvesting, bone shaping, laminectomy, entry hole, suture hole, and midface advancement.	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.		2008-05-30	Terminated
Z-1574-05	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.		2005-09-01	Terminated
Z-1067-05	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.		2005-06-29	Terminated
Z-0441-05	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.		2005-01-03	Terminated
Z-0278-05	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.		2004-11-11	Terminated
Z-0213-05	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).		2004-11-03	Terminated
Z-0419-03	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.		2002-11-11	Terminated

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain