Skip to content

NextAR TSA Platform 5.3SSWNXAR

by Medacta International SA

Ref 5.3SSWNXAR

NextAR TSA Platform 5.3SSWNXAR is an optical surgical navigation/tracking system (EU MDD Class I; FDA Class II; FDA product code SBF, Orthopedic Augmented Reality) made by Medacta International SA, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-07630345729316), cleared under FDA 510(k) K232280 on 29 Oct 2023 and listed in FDA GUDID since 13 Apr 2026 (UDI-DI 07630345729316), active as of 12 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 12 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K232280

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07630345729316 Basic UDI-DI 07630345729316UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630345729316 UDI-DI Date13 Apr 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK232280 Date29 Oct 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07630345729316 registered 6 Nov 2026 Active
  • FDA 510(k) K232280 decided 29 Oct 2023 Active
  • FDA GUDID UDI-DI 07630345729316 listed 13 Apr 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K232280
  2. Listed FDA GUDID 07630345729316
  3. Registered EUDAMED B-07630345729316

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
NextAR Shoulder software EUDAMED
NextAR TSA Platform GUDID
Generic name
Optical surgical navigation/tracking system
Device name
Shoulder Software
Model / reference
5.3SSWNXAR
Primary DI / UDI-DI
07630345729316
Basic UDI-DI
B-07630345729316
510(k) Number
FDA product code
SBF
EMDN code
Z12130492 Stereotactic orthopaedic surgery instruments - medical device software
GMDN term
Optical surgical navigation/tracking system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.4560
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

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

Cleared under the same submission (K232280)

and 1 more cleared under K232280

Similar devices in this category

Other devices filed under STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS.

Other devices from Medacta International SA

See all devices from Medacta International SA →

Properties

  • Measuring function
  • Lot / batch number
Other properties (23, all answered No)