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MyKnee 8.2046S

by Medacta International

Ref 8.2046SModel Knee Pin positioner TKA - sterile

MyKnee 8.2046S is a device classified as Class IIa in the EU and Class II in the US made by Medacta International, registered in EUDAMED on 20 Jul 2026 (Basic UDI-DI 764014274KSP0992R00FE), cleared under FDA 510(k) K170106 on 20 Oct 2017 and listed in FDA GUDID since 3 Feb 2021 (UDI-DI 07630040714709), active as of 23 Oct 2026.

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 found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K170106

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number764014274KSP0992R00FE Basic UDI-DI 07630040714709UDI-DIDate20 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630040714709 UDI-DI Date3 Feb 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK170106 Date20 Oct 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 764014274KSP0992R00FE registered 20 Jul 2026 Active
  • FDA 510(k) K170106 decided 20 Oct 2017 Active
  • FDA GUDID UDI-DI 07630040714709 listed 3 Feb 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K170106
  2. Listed FDA GUDID 07630040714709
  3. Registered EUDAMED 764014274KSP0992R00FE

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  • Withdrawn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
MyKnee STD TibPinPosit-MRI-GMK-RM-#6 ST EUDAMED
MyKnee GUDID
Generic name
Orthopaedic prosthesis implantation positioning instrument, single-use
Model / reference
8.2046S, Knee Pin positioner TKA - sterile
Primary DI / UDI-DI
07630040714709
Basic UDI-DI
764014274KSP0992R00FE
510(k) Number
FDA product code
JWH
EMDN code
K01020114 Minimally invasive surgery guides, single-use
GMDN term
Orthopaedic prosthesis implantation positioning instrument, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3560
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

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: Orthopaedic prosthesis implantation positioning instrument, single-use

Cleared under the same submission (K170106)

and 8 more cleared under K170106

Similar devices in this category

Other devices filed under MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENTS, SINGLE-USE.

Other devices from Medacta International

See all devices from Medacta International →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)