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Midas Rex Legend PM200

by Medtronic Powered Surgical Solutions

Ref PM200

Midas Rex Legend PM200 is a device classified as Class IIa in the EU and Class II in the US made by Medtronic Powered Surgical Solutions, registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI 0763000B00013367R), cleared under FDA 510(k) K163182 on 23 Mar 2017 (1 earlier submission) and listed in FDA GUDID since 5 Dec 2021 (UDI-DI 00763000430979), active as of 7 Nov 2026. 8 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

9 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K163182

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00013367R Basic UDI-DI Date27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000430979 UDI-DI Date5 Dec 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK163182 Date23 Mar 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00013367R registered 27 Oct 2026 Active
  • FDA 510(k) K163182 decided 23 Mar 2017 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00763000430979 listed 5 Dec 2021 Listed

Recalls

9 recalls · FDA

    • Terminated Z-1602-2016 FDA Class II initiated 8 Apr 2016

    Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.

    • Terminated Z-0321-2016 FDA Class II initiated 21 Oct 2015

    The wire pass hole is not present on the tools.

    • Terminated Z-0546-2010 FDA Unclassified (pre-2012) initiated 30 Nov 2009

    Component of product attachment may be outside established tolerance with potential for footed portion to break during normal use.

    • Terminated Z-2156-2008 FDA Unclassified (pre-2012) initiated 30 May 2008

    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.

    • Terminated Z-1574-05 FDA Unclassified (pre-2012) initiated 1 Sep 2005 on shared 510(k) K020069

    Potential compromise of sterile packaging for disposable dissecting tools.

    • Terminated Z-1067-05 FDA Unclassified (pre-2012) initiated 29 Jun 2005

    Complaints of finger control component breaking off and falling into open surgical wound.

    • Terminated Z-0278-05 FDA Unclassified (pre-2012) initiated 11 Nov 2004

    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.

    • Terminated Z-0213-05 FDA Unclassified (pre-2012) initiated 3 Nov 2004

    Reduced plastic thickness of lubricant/diffuser cartidge can crack under pressure causing leakage of lubricant as visible mist (appearance of smoke).

    • Terminated Z-0419-03 FDA Unclassified (pre-2012) initiated 11 Nov 2002

    Lubricant leaking from motor after sterilization causing bleed-through sterilization wrap and/or excess lubricant in instrument case.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

13 dated events

  1. Recall initiated FDA recalls Z-0278-05
  2. Recall initiated FDA recalls Z-1067-05
  3. Recall initiated FDA recalls Z-1574-05
  4. Recall initiated FDA recalls Z-2156-2008
  5. Recall initiated FDA recalls Z-0546-2010
  6. Recall initiated FDA recalls Z-0321-2016
  7. Recall initiated FDA recalls Z-1602-2016
  8. Cleared FDA 510(k) K163182
  9. Listed FDA GUDID 00763000430979
  10. Registered EUDAMED 0763000B00013367R

3 earlier events are in the sections above.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Midas Rex Legend
Generic name
Surgical power tool system control unit, pneumatic
Device name
Legend Platinum Motor
Model / reference
PM200
Primary DI / UDI-DI
00763000430979, 00763000728601
Basic UDI-DI
0763000B00013367R
510(k) Number
FDA product code
HBB
EMDN code
Z12100902 Drills for neurosurgery
GMDN term
Surgical power tool system control unit, pneumatic
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.4370
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Surgical power tool system control unit, pneumatic

Cleared under the same submission (K020069)

and 8 more cleared under K020069

Cleared under the same submission (K163182)

and 8 more cleared under K163182

Similar devices in this category

Other devices filed under DRILLS FOR NEUROSURGERY.

Other devices from Medtronic Powered Surgical Solutions

See all devices from Medtronic Powered Surgical Solutions →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (22, all answered No)