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V40 110755

by MAKO Surgical Corp.

Ref 110755Model 08858251002224SA

V40 110755 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 8 Jul 2026 (Basic UDI-DI 08858251002224SA), cleared under FDA 510(k) K170593 on 18 Apr 2017 (1 earlier submission) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00848486017187), active as of 25 Oct 2026. 4 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

4 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K170593

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002224SA Basic UDI-DI 00848486017187UDI-DIDate8 Jul 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK170593 Date18 Apr 2017DecidedStatusActive
United StatesGUDID listing GUDID Number00848486017187 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08858251002224SA registered 8 Jul 2026 Active
  • FDA 510(k) K170593 decided 18 Apr 2017 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00848486017187 listed 24 Sep 2016 Listed

Recalls

4 recalls · FDA

    • 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-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

Timeline

8 dated events

  1. Cleared FDA 510(k) K141989
  2. Listed FDA GUDID 00848486017187
  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-2745-2020
  8. Registered EUDAMED 08858251002224SA

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
V40 GUDID
Generic name
Patient positioning sensor
Device name
TD-01 - MAKO - Class I (r) - Tracking-Metal and Plastic
Model / Ref / Catalog
110755, 08858251002224SA
Primary DI / UDI-DI
00848486017187
Basic UDI-DI
08858251002224SA
Direct marketing DI
00848486017187
510(k) Number
FDA product code
OLO
EMDN code
Z12130480 Stereotactic orthopaedic surgery instruments - hardware accessories
GMDN term
Patient positioning sensor
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
Sterilisation method
Moist Heat or Steam Sterilization

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: Patient positioning sensor

Cleared under the same submission (K141989)

and 8 more cleared under K141989

Cleared under the same submission (K170593)

and 8 more cleared under K170593

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
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)