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Restoris 111540

by MAKO Surgical Corp.

Ref 111540Model 08858251002268SW

Restoris 111540 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 5 Aug 2026 (Basic UDI-DI 08858251002268SW), cleared under FDA 510(k) K090763 on 17 Jun 2009 (1 earlier submission) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00848486017286), active as of 24 Oct 2026. 5 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

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K090763

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002268SW Basic UDI-DI 00848486017286UDI-DIDate5 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00848486017286 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK090763 Date17 Jun 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08858251002268SW registered 5 Aug 2026 Active
  • FDA 510(k) K090763 decided 17 Jun 2009 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00848486017286 listed 24 Sep 2016 Listed

Recalls

5 recalls · 2 ongoing · FDA

    • Ongoing Z-1386-2023 FDA Class II initiated 10 Mar 2023

    Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking

    • Ongoing Z-1385-2023 FDA Class II initiated 10 Mar 2023

    Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking

    • Terminated Z-2051-2018 FDA Class II initiated 19 Jan 2018

    Possible hinge pin disassociation from the Mako Onlay Insert Extractor.

    • Terminated Z-1031-2016 FDA Class II initiated 15 Jan 2016

    Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier.

    • Terminated Z-1132-2014 FDA Class II initiated 9 Jan 2014

    The product may be mislabeled and could result in the incorrect implant being used.

Timeline

9 dated events

  1. Cleared FDA 510(k) K082172
  2. Cleared FDA 510(k) K090763
  3. Recall initiated FDA recalls Z-1132-2014
  4. Recall initiated FDA recalls Z-1031-2016
  5. Listed FDA GUDID 00848486017286
  6. Recall initiated FDA recalls Z-2051-2018
  7. Recall initiated FDA recalls Z-1386-2023
  8. Recall initiated FDA recalls Z-1385-2023
  9. Registered EUDAMED 08858251002268SW

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 GUDID
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device name
TD-02 - MAKO - Class I (r) - Sizing - Metal
Model / Ref / Catalog
111540, 08858251002268SW
Primary DI / UDI-DI
00848486017286
Basic UDI-DI
08858251002268SW
Direct marketing DI
00848486017286
510(k) Number
FDA product code
HSX, KRR, HRY, NPJ
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3520, 888.3540, 888.3530, 888.3560
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: Orthopaedic prosthesis implantation positioning instrument, reusable

Cleared under the same submission (K082172)

and 8 more cleared under K082172

Cleared under the same submission (K090763)

and 8 more cleared under K090763

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

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)