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GMK Sphere Total Knee System 02.12.E0313FL

by Medacta International

Ref 02.12.E0313FL

GMK Sphere Total Knee System 02.12.E0313FL is a device classified as Class III in the EU and Class II in the US made by Medacta International, registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI B-07630971261631), cleared under FDA 510(k) K202022 on 18 Sep 2020 and listed in FDA GUDID since 24 Sep 2020 (UDI-DI 07630971261631), active as of 7 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K202022

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07630971261631 Basic UDI-DI 07630971261631UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630971261631 UDI-DI Date24 Sep 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK202022 Date18 Sep 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07630971261631 registered 4 Nov 2026 Active
  • FDA 510(k) K202022 decided 18 Sep 2020 Active
  • FDA GUDID UDI-DI 07630971261631 listed 24 Sep 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K202022
  2. Listed FDA GUDID 07630971261631
  3. Registered EUDAMED B-07630971261631

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  • Withdrawn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
GMK-SPHERE tibial insert E-Cross - Flex 3L - 13mm EUDAMED
GMK Sphere Total Knee System GUDID
Generic name
Tibial insert
Device name
Knee Tibial insert fixed total Vit.E
Model / reference
02.12.E0313FL
Description
Tibial Insert Fixed SPHERE FLEX #3/13 mm L E-Cross
Primary DI / UDI-DI
07630971261631
Basic UDI-DI
B-07630971261631
510(k) Number
FDA product code
JWH
EMDN code
P090903020202, P090905020202
GMDN term
Tibial insert
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3560
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 III
GUDID
Class II

Device class is stated on each registry's own scale: Class III 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: Tibial insert

Cleared under the same submission (K202022)

and 8 more cleared under K202022

Similar devices in this category

Other devices filed under BICOMPARTMENTAL PRIMARY IMPLANT FIXED BEARING TIBIAL INSERTS.

Other devices from Medacta International

See all devices from Medacta International →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)