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Accolade II 210433-3237

by MAKO Surgical Corp.

Part of a family of 10 devices: see the family page

Ref 210433-3237Model 08858251002219SH

Accolade II 210433-3237 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 12 Oct 2026 (Basic UDI-DI 08858251002219SH), cleared under FDA 510(k) K170593 on 18 Apr 2017 (1 earlier submission) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00848486028121), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002219SH Basic UDI-DI 00848486028121UDI-DIDate12 Oct 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK170593 Date18 Apr 2017DecidedStatusActive
United StatesGUDID listing GUDID Number00848486028121 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08858251002219SH registered 12 Oct 2026 Active
  • FDA 510(k) K170593 decided 18 Apr 2017 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00848486028121 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 00848486028121
  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 08858251002219SH

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
Accolade II GUDID
Generic name
Femoral stem prosthesis trial
Device name
TD-01 - MAKO - Class IIa - Facsimile Procedures Devices
Model / Ref / Catalog
210433-3237, 08858251002219SH
Primary DI / UDI-DI
00848486028121
Basic UDI-DI
08858251002219SH
Direct marketing DI
00848486028121
510(k) Number
FDA product code
OLO
EMDN code
V06010101 Hip prostheses testing devices
GMDN term
Femoral stem prosthesis trial
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
Size
Length — 37.0 Millimeter

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: Femoral stem prosthesis trial

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 HIP PROSTHESES TESTING DEVICES.

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)