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PHYSICA PS Tibial Liner

by Limacorporate 60 variants

Ref 6535.50.212Model PHYSICA PS - TIBIAL LINER #2 H.12 MM

PHYSICA PS Tibial Liner (6535.50.212) is a device classified as Class III in the EU and Class II in the US made by Limacorporate, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-08033390095778), cleared under FDA 510(k) K152008 on 29 Oct 2015 and listed in FDA GUDID since 4 Nov 2015 (UDI-DI 08033390095778), 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) K152008

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-08033390095778 Basic UDI-DI 08033390095778UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033390095778 UDI-DI Date4 Nov 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK152008 Date29 Oct 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08033390095778 registered 6 Nov 2026 Active
  • FDA 510(k) K152008 decided 29 Oct 2015 Active
  • FDA GUDID UDI-DI 08033390095778 listed 4 Nov 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K152008
  2. Listed FDA GUDID 08033390095778
  3. Registered EUDAMED B-08033390095778

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  • Withdrawn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
Physica Ps - Tibial Liner #2 H.12 Mm EUDAMED
Physica Ps GUDID
Generic name
Tibial insert
Model / Ref / Catalog
PHYSICA PS - TIBIAL LINER #2 H.12 MM, 6535.50.212, Tibial Liner
Primary DI / UDI-DI
08033390095778
Basic UDI-DI
B-08033390095778
510(k) Number
FDA product code
JWH
EMDN code
P090903020202 Bicompartmental primary implant fixed bearing tibial inserts
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 · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
PHYSICA PS - TIBIAL LINER #2 H.12 MM
6535.50.212
GUDID
Tibial Liner
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 (K152008)

and 8 more cleared under K152008

Similar devices in this category

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

Other devices from Limacorporate

See all devices from Limacorporate →

Properties

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