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Midas Rex Microsaws 110S58-03-Arc

by Medtronic Powered Surgical Solutions

Ref 110S58-03-ARC

Midas Rex Microsaws 110S58-03-Arc 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 28 Sep 2026 (Basic UDI-DI 0763000B000138382), cleared under FDA 510(k) K081475 on 17 Oct 2008 and listed in FDA GUDID since 18 Mar 2022 (UDI-DI 00763000463588), active as of 7 Nov 2026. 3 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

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K081475

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 Number0763000B000138382 Basic UDI-DI 00763000463588UDI-DIDate28 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000463588 UDI-DI Date18 Mar 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK081475 Date17 Oct 2008DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B000138382 registered 28 Sep 2026 Active
  • FDA 510(k) K081475 decided 17 Oct 2008 Active
  • FDA GUDID UDI-DI 00763000463588 listed 18 Mar 2022 Listed

Recalls

3 recalls · 1 ongoing · FDA

    • Ongoing Z-0158-2022 FDA Class II initiated 31 Aug 2021

    There was an increase in complaints related to tip breaks and wobble/vibration.

    • Terminated Z-0961-2022 FDA Class II initiated 15 Dec 2021

    As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) being used with software version: v2.7.3.0, it was discovered that there was a defect that resulted in a difference between the set number of rotations and the actual number of rotations in a specific mode when the product was used with our company's M5 handpiece.

    • Terminated Z-2085-2016 FDA Class II initiated 13 May 2016

    Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm Seal identified a potential for leakage of fluid into the motor during use.

Timeline

6 dated events

  1. Cleared FDA 510(k) K081475
  2. Recall initiated FDA recalls Z-2085-2016
  3. Recall initiated FDA recalls Z-0158-2022
  4. Recall initiated FDA recalls Z-0961-2022
  5. Listed FDA GUDID 00763000463588
  6. Registered EUDAMED 0763000B000138382

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 Microsaws
Generic name
Orthopaedic bur, single-use
Device name
Midas Rex Sagittal Oscillating Blade
Model / reference
110S58-03-ARC
Primary DI / UDI-DI
00763000463588
Basic UDI-DI
0763000B000138382
510(k) Number
FDA product code
ERL, 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
874.4250, 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 (K081475)

and 8 more cleared under K081475

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)