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Rio 207138

by MAKO Surgical Corp.

Ref 207138Model 08858251002245SJ

Rio 207138 is a device classified as Class I in the EU and Class II in the US made by MAKO Surgical Corp., registered in EUDAMED on 12 Oct 2026 (Basic UDI-DI 08858251002245SJ), cleared under FDA 510(k) K112507 on 1 Mar 2012 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00848486015879), active as of 24 Oct 2026. 6 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

6 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K112507

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002245SJ Basic UDI-DI 00848486015879UDI-DIDate12 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00848486015879 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK112507 Date1 Mar 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08858251002245SJ registered 12 Oct 2026 Active
  • FDA 510(k) K112507 decided 1 Mar 2012 Active
  • FDA GUDID UDI-DI 00848486015879 listed 24 Sep 2016 Listed

Recalls

6 recalls · FDA

    • Terminated Z-2924-2018 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-3130-2017 FDA Class II initiated 7 Aug 2017

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

    • Terminated Z-2741-2017 FDA Class II initiated 7 Jun 2017

    An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection.

    • 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.

    • Terminated Z-1128-2015 FDA Class II initiated 22 Jan 2015

    When using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outside of the stereotactic boundary and after the control switches (foot pedal and trigger) cease to be activated

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

    Revision of the field manual

Timeline

9 dated events

  1. Cleared FDA 510(k) K112507
  2. Recall initiated FDA recalls Z-1508-2016
  3. Recall initiated FDA recalls Z-1128-2015
  4. Recall initiated FDA recalls Z-0224-2016
  5. Listed FDA GUDID 00848486015879
  6. Recall initiated FDA recalls Z-2741-2017
  7. Recall initiated FDA recalls Z-3130-2017
  8. Recall initiated FDA recalls Z-2924-2018
  9. Registered EUDAMED 08858251002245SJ

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
Rio GUDID
Generic name
Foot-switch, electrical
Device name
TD-01 - MAKO - Class I - Instrument - Electrical Component
Model / Ref / Catalog
207138, 08858251002245SJ
Primary DI / UDI-DI
00848486015879
Basic UDI-DI
08858251002245SJ
Direct marketing DI
00848486015879
FDA product code
OLO
EMDN code
Z12130480 Stereotactic orthopaedic surgery instruments - hardware accessories
GMDN term
Foot-switch, electrical
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.4560
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 I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Foot-switch, electrical

Cleared under the same submission (K112507)

and 8 more cleared under K112507

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

  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)