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Midas Rex Microsaws 185S55-04F

by Medtronic Powered Surgical Solutions

Midas Rex Microsaws 185S55-04F is a Class II device made by Medtronic Powered Surgical Solutions, cleared under FDA 510(k) K081475 on 17 Oct 2008 and listed in FDA GUDID since 18 Mar 2022 (UDI-DI 00763000463878), active as of 23 Oct 2026. 3 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K081475

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00763000463878 UDI-DI Date18 Mar 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK081475 Date17 Oct 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K081475 decided 17 Oct 2008 Active
  • FDA GUDID UDI-DI 00763000463878 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

5 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 00763000463878

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Midas Rex Microsaws
Generic name
Orthopaedic bur, single-use
Model / reference
185S55-04F
Primary DI / UDI-DI
00763000463878
510(k) Number
FDA product code
ERL, HBE
GMDN term
Orthopaedic bur, single-use
Device class
Class II
Regulation number
874.4250, 882.4310
GUDID distribution status
In Commercial Distribution

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 Orthopaedic bur, single-use.

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 (11, all answered No)