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REVISION HIP - Ti6Al4V

by Limacorporate 16 variants

Ref 3811.15.020Model REVISION HIP - UNCEMENTED STEM D.15 MM L.200 MM

REVISION HIP - Ti6Al4V (3811.15.020) 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-08033390111102), cleared under FDA 510(k) K161226 on 10 Feb 2017 and listed in FDA GUDID since 15 Feb 2017 (UDI-DI 08033390111102), 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) K161226

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-08033390111102 Basic UDI-DI 08033390111102UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033390111102 UDI-DI Date15 Feb 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK161226 Date10 Feb 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08033390111102 registered 6 Nov 2026 Active
  • FDA 510(k) K161226 decided 10 Feb 2017 Active
  • FDA GUDID UDI-DI 08033390111102 listed 15 Feb 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K161226
  2. Listed FDA GUDID 08033390111102
  3. Registered EUDAMED B-08033390111102

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  • Withdrawn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
Revision Hip - Uncemented Stem D.15 Mm L.200 Mm EUDAMED
Revision GUDID
Generic name
Revision uncoated femoral stem prosthesis
Model / Ref / Catalog
REVISION HIP - UNCEMENTED STEM D.15 MM L.200 MM, 3811.15.020, REVISION HIP - Ti6Al4V
Primary DI / UDI-DI
08033390111102
Basic UDI-DI
B-08033390111102
510(k) Number
FDA product code
KWY, LPH, LZO
EMDN code
P090804030202 Revision uncemented femoral stems, with modular neck
GMDN term
Revision uncoated femoral stem prosthesis
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3390, 888.3358, 888.3353
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
REVISION HIP - UNCEMENTED STEM D.15 MM L.200 MM
3811.15.020
GUDID
REVISION HIP - Ti6Al4V
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: Revision uncoated femoral stem prosthesis

Cleared under the same submission (K161226)

and 8 more cleared under K161226

Similar devices in this category

Other devices filed under REVISION UNCEMENTED FEMORAL STEMS, WITH MODULAR NECK.

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)