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Patient Reference Array T-Geometry X-Press

by Brainlab SE

Ref 52410A

Patient Reference Array T-Geometry X-Press (52410A) is a device classified as Class I in the EU and Class II in the US made by Brainlab SE, cleared under FDA 510(k) K252562 on 12 Sep 2025 (2 earlier submissions), registered in EUDAMED on 21 May 2024 (Basic UDI-DI 4056481PatRefArrayE8) and listed in FDA GUDID since 15 Sep 2016 (UDI-DI 04056481002404), active as of 22 Oct 2026. One FDA recall is 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

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K252562

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK252562 Date12 Sep 2025DecidedStatusActive
European UnionCE/MDR EUDAMED Number4056481PatRefArrayE8 Basic UDI-DI 04056481002404UDI-DIDate21 May 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number04056481002404 UDI-DI Date15 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • FDA 510(k) K252562 decided 12 Sep 2025 Active· +2 more in the status table
  • EUDAMED Basic UDI-DI 4056481PatRefArrayE8 registered 21 May 2024 Active
  • FDA GUDID UDI-DI 04056481002404 listed 15 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-0959-2017 FDA Class II initiated 27 Oct 2016

    Brainlab Knee Navigation System: Femoral and Tibial Cutting Block Adapter Base with specific serial numbers might contain parts made from incorrect material and therefore not be suitable for reprocessing

Timeline

6 dated events

  1. Cleared FDA 510(k) K102990
  2. Listed FDA GUDID 04056481002404
  3. Recall initiated FDA recalls Z-0959-2017
  4. Cleared FDA 510(k) K193307
  5. Registered EUDAMED 4056481PatRefArrayE8
  6. Cleared FDA 510(k) K252562

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  • Withdrawn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
Patient Reference Array T-Geometry X-Press EUDAMED
Reference Array T-Geometry, X-Press GUDID
Generic name
Robotic surgical navigation system
Device name
Patient Reference Array Spine & Trauma
Model / Ref / Catalog
52410A
Primary DI / UDI-DI
04056481002404
Basic UDI-DI
4056481PatRefArrayE8
Direct marketing DI
04056481002404
FDA product code
OLO
EMDN code
Z12011480 Surgical navigation instruments - hardware accessories
GMDN term
Robotic surgical navigation system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.4560
EU registration type
Standard device
EU market of registration
Germany
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.

Manufacturer details

EUDAMED SRN
DE-MF-000006183

Similar devices in this category

Other devices filed under SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Brainlab SE

See all devices from Brainlab SE →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (22, all answered No)