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Midas Rex Legend DS1TD32

by Medtronic Powered Surgical Solutions

Ref DS1TD32

Midas Rex Legend DS1TD32 is an orthopaedic bur (EU MDR Class IIa; FDA Class II; FDA product code HBE, Drills, Burrs, Trephines & Accessories (Simple, Powered)) made by Medtronic Powered Surgical Solutions, registered in EUDAMED on 28 Sep 2026 (Basic UDI-DI 0763000B00013878A), cleared under FDA 510(k) K191597 on 1 Nov 2019 and listed in FDA GUDID since 26 May 2022 (UDI-DI 00763000462956), active as of 7 Nov 2026.

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

1 ongoing

Recall on shared 510(k) K191597; other models may be affected

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K191597

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00013878A Basic UDI-DI 00763000462956UDI-DIDate28 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000462956 UDI-DI Date26 May 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK191597 Date1 Nov 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00013878A registered 28 Sep 2026 Active
  • FDA 510(k) K191597 decided 1 Nov 2019 Active
  • FDA GUDID UDI-DI 00763000462956 listed 26 May 2022 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0417-2022 FDA Class II initiated 9 Nov 2021 on shared 510(k) K191597

    A tracker that holds and guides neurosurgical surgical instruments may be subject to separation/weld failure, where the tracker connects to the instrument tube. If a weld separation occurs and a navigation inaccuracy is experienced, it may result in prolonged procedure and tissue injury. Per 11/24/21 firm email: The Bundle Autoguide Reg Kit does not have a model number. The Bundle Autoguide Reg Kit is internal terminology and not visible to the customer and are used as sales and shipping configuration only. When this sales bundle is chosen by an internal Medtronic Sales Representative the devices included in the bundle are individually packaged and labeled and sent to the customer in a single shipment. The devices included in the bundle are ordered, packed, and shipped as individual medical devices with unique model numbers, which is the reason that the Autoguide Tracker (28248) and the Stealth Autoguide Basic Instrument Kit (9736188) are the only part numbers subject to this FCA.

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

Timeline

4 dated events

  1. Cleared FDA 510(k) K191597
  2. Recall initiated FDA recalls Z-0417-2022
  3. Listed FDA GUDID 00763000462956
  4. Registered EUDAMED 0763000B00013878A

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
Orthopaedic bur, single-use
Device name
Midas Rex™ Legend
Model / reference
DS1TD32
Primary DI / UDI-DI
00763000462956
Basic UDI-DI
0763000B00013878A
510(k) Number
FDA product code
HBE
EMDN code
Z12100985 Instruments for motorised neurosurgery systems - consumables
GMDN term
Orthopaedic bur, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.4310
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

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: Orthopaedic bur, single-use

Cleared under the same submission (K191597)

and 8 more cleared under K191597

Similar devices in this category

Other devices filed under INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS.

Other devices from Medtronic Powered Surgical Solutions

See all devices from Medtronic Powered Surgical Solutions →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)