Skip to content

KneePlus Knee+

by Pixee Medical 2 variants

Ref KNS170

KneePlus Knee+ (KNS170) is a device classified as Class IIa in the EU and Class II in the US made by Pixee Medical, registered in EUDAMED on 28 May 2026 (Basic UDI-DI 376029703LOGICIELZS) and listed in FDA GUDID since 18 Apr 2025 (UDI-DI 03760297030469), active as of 25 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number376029703LOGICIELZS Basic UDI-DI 03760297030469UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760297030469 UDI-DI Date18 Apr 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 376029703LOGICIELZS registered 28 May 2026 Active
  • FDA GUDID UDI-DI 03760297030469 listed 18 Apr 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03760297030469
  2. Registered EUDAMED 376029703LOGICIELZS

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
KneePlus v1.7 EUDAMED
KneePlus GUDID
Generic name
Orthopaedic stereotactic surgery system
Device name
Orthopedic software
Model / Ref / Catalog
KNS170, Knee+
Primary DI / UDI-DI
03760297030469
Basic UDI-DI
376029703LOGICIELZS
FDA product code
SBF
EMDN code
Z12130482 Stereotactic orthopaedic surgery instruments - software accessories
GMDN term
Orthopaedic stereotactic surgery system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.4560
Special device type
Software
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
KNS170
GUDID
Knee+
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: Orthopaedic stereotactic surgery system

Similar devices in this category

Other devices filed under STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS.

Other devices from Pixee Medical

See all devices from Pixee Medical →

Properties

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