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Restoris, Rio 207084

by MAKO Surgical Corp.

Ref 207084Model 08858251002222S6

Restoris, Rio 207084 is a device classified as Class IIa in the EU and Class II in the US made by MAKO Surgical Corp., registered in EUDAMED on 5 Aug 2026 (Basic UDI-DI 08858251002222S6), cleared under FDA 510(k) K170593 on 18 Apr 2017 (2 earlier submissions) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00848486022204), active as of 23 Oct 2026. 14 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

14 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K170593

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002222S6 Basic UDI-DI 00848486022204UDI-DIDate5 Aug 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK170593 Date18 Apr 2017DecidedStatusActive
United StatesGUDID listing GUDID Number00848486022204 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08858251002222S6 registered 5 Aug 2026 Active
  • FDA 510(k) K170593 decided 18 Apr 2017 Active· +2 more in the status table
  • FDA GUDID UDI-DI 00848486022204 listed 24 Sep 2016 Listed

Recalls

14 recalls · FDA

    • Terminated Z-1735-2022 FDA Class II initiated 8 Aug 2022

    Certain units have the potential to exhibit infant failures whereby units either arrive non-functional, have the potential to become non-functional, or flash an error light while in use.

    • Terminated Z-2745-2020 FDA Class II initiated 9 Jul 2020

    Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures.

    • Terminated Z-2925-2018 FDA Class II initiated 24 Jul 2018

    Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to be damaged on the Vizadisc reflective material causing an inability to be detected by the camera.

    • Terminated Z-3182-2018 FDA Class II initiated 27 Dec 2017

    Communication-connection error.

    • Terminated Z-3131-2017 FDA Class II initiated 7 Aug 2017

    Software discrepancy of not showing all the EE constants, when the screen is filled.

    • Terminated Z-1411-2017 FDA Class II initiated 22 Dec 2016

    Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides

    • Terminated Z-1193-2017 FDA Class II initiated 29 Sep 2016

    Failure of the Offset Cup Reamer Handle not engaging its mating components.

    • Terminated Z-1583-2016 FDA Class II initiated 23 Feb 2016

    Potential disassociation of the orientation pin.

    • Terminated Z-1588-2016 FDA Class II initiated 25 Nov 2015

    Stryker Orthpaedics became aware that there is the potential for the 210540 MAKOplasty Hip Array Kit Laminate 150230 to list two part numbers for the RIO Base Array, which is item #5 on the product table.

    • Terminated Z-0224-2016 FDA Class II initiated 16 Jul 2015

    The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector.

  • 3 recalls, same reason

    • Terminated Z-0829-2015 FDA Class II initiated 7 Oct 2014
    • Terminated Z-0830-2015 FDA Class II initiated 7 Oct 2014
    • Terminated Z-0828-2015 FDA Class II initiated 7 Oct 2014

    MAKO has identified the potential that the shell impactors may be damaged intraoperatively.

    • Terminated Z-1508-2016 FDA Class II initiated 30 Apr 2014

    Revision of the field manual

Timeline

19 dated events

  1. Listed FDA GUDID 00848486022204
  2. Recall initiated FDA recalls Z-1193-2017
  3. Recall initiated FDA recalls Z-1411-2017
  4. Cleared FDA 510(k) K170593
  5. Recall initiated FDA recalls Z-3131-2017
  6. Recall initiated FDA recalls Z-3182-2018
  7. Recall initiated FDA recalls Z-2925-2018
  8. Recall initiated FDA recalls Z-2745-2020
  9. Recall initiated FDA recalls Z-1735-2022
  10. Registered EUDAMED 08858251002222S6

9 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
Mako EUDAMED
Restoris, Rio GUDID
Generic name
Surgical power tool system handpiece, reaming, pneumatic
Device name
TD-01 - MAKO - Class IIa - Reamer Handle - Metal
Model / Ref / Catalog
207084, 08858251002222S6
Primary DI / UDI-DI
00848486022204
Basic UDI-DI
08858251002222S6
Direct marketing DI
00848486022204
FDA product code
OLO
EMDN code
Z12130480 Stereotactic orthopaedic surgery instruments - hardware accessories
GMDN term
Surgical power tool system handpiece, reaming, pneumatic
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.4560
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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 handpiece, reaming, pneumatic

Cleared under the same submission (K121064)

and 8 more cleared under K121064

Cleared under the same submission (K141989)

and 8 more cleared under K141989

Similar devices in this category

Other devices filed under STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from MAKO Surgical Corp.

See all devices from MAKO Surgical Corp. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)