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Mako TKA 2.0.1+TKA 1.0.3+THA 4.0.2+PKA 3.0.4

by MAKO Surgical Corp.

Ref 700002150478Model 08858251002272SM

Mako TKA 2.0.1+TKA 1.0.3+THA 4.0.2+PKA 3.0.4 (700002150478) 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 20 May 2026 (Basic UDI-DI 08858251002272SM), cleared under FDA 510(k) K220459 on 15 Apr 2022 and listed in FDA GUDID since 21 Jul 2023 (UDI-DI 07613327600063), active as of 25 Oct 2026. 7 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

7 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K220459

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002272SM Basic UDI-DI 07613327600063UDI-DIDate20 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327600063 UDI-DI Date21 Jul 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK220459 Date15 Apr 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08858251002272SM registered 20 May 2026 Active
  • FDA 510(k) K220459 decided 15 Apr 2022 Active
  • FDA GUDID UDI-DI 07613327600063 listed 21 Jul 2023 Listed

Recalls

7 recalls · 7 ongoing · FDA

    • Ongoing Z-1572-2026 FDA Class II initiated 2 Feb 2026

    A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the cover to the Angled Saw Housing, may loosen during use and detach from the attachment.

  • 6 recalls, same reason

    • Ongoing Z-1914-2024 FDA Class II initiated 15 Apr 2024
    • Ongoing Z-1910-2024 FDA Class II initiated 15 Apr 2024
    • Ongoing Z-1915-2024 FDA Class II initiated 15 Apr 2024
    • Ongoing Z-1912-2024 FDA Class II initiated 15 Apr 2024
    • Ongoing Z-1913-2024 FDA Class II initiated 15 Apr 2024
    • Ongoing Z-1911-2024 FDA Class II initiated 15 Apr 2024

    Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment

Timeline

10 dated events

  1. Cleared FDA 510(k) K220459
  2. Listed FDA GUDID 07613327600063
  3. Recall initiated FDA recalls Z-1914-2024
  4. Recall initiated FDA recalls Z-1910-2024
  5. Recall initiated FDA recalls Z-1915-2024
  6. Recall initiated FDA recalls Z-1912-2024
  7. Recall initiated FDA recalls Z-1913-2024
  8. Recall initiated FDA recalls Z-1911-2024
  9. Recall initiated FDA recalls Z-1572-2026
  10. Registered EUDAMED 08858251002272SM

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
Generic name
Robotic surgical navigation system application software
Device name
TD-04 - MAKO - Class IIa - Software Discs
Model / Ref / Catalog
08858251002272SM, 700002150478, TKA 2.0.1+TKA 1.0.3+THA 4.0.2+PKA 3.0.4
Primary DI / UDI-DI
07613327600063
Basic UDI-DI
08858251002272SM
510(k) Number
FDA product code
OLO
EMDN code
Z12130482 Stereotactic orthopaedic surgery instruments - software accessories
GMDN term
Robotic surgical navigation system application software
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

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
08858251002272SM
700002150478
GUDID
TKA 2.0.1+TKA 1.0.3+THA 4.0.2+PKA 3.0.4
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: Robotic surgical navigation system application software

Cleared under the same submission (K220459)

and 1 more cleared under K220459

Similar devices in this category

Other devices filed under STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS.

Other devices from MAKO Surgical Corp.

See all devices from MAKO Surgical Corp. →

Properties

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