Skip to content

Mpact Acetabular System 01.31.55TP

by Medacta International SA

Ref 01.31.55TP

Mpact Acetabular System 01.31.55TP is a device classified as Class III in the EU and Class II in the US made by Medacta International SA, registered in EUDAMED on 15 Oct 2026 (Basic UDI-DI B-07630030860911), cleared under FDA 510(k) K103721 on 21 Mar 2011 and listed in FDA GUDID since 18 Nov 2014 (UDI-DI 07630030860911), active as of 12 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 12 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K103721

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07630030860911 Basic UDI-DI 07630030860911UDI-DIDate15 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630030860911 UDI-DI Date18 Nov 2014ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK103721 Date21 Mar 2011DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07630030860911 registered 15 Oct 2026 Active
  • FDA 510(k) K103721 decided 21 Mar 2011 Active
  • FDA GUDID UDI-DI 07630030860911 listed 18 Nov 2014 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K103721
  2. Listed FDA GUDID 07630030860911
  3. Registered EUDAMED B-07630030860911

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  • Withdrawn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
Shell Screw Plug EUDAMED
Mpact Acetabular System GUDID
Generic name
Acetabulum prosthesis hole plug
Device name
Hip Mpact Shell Screw Plug
Model / reference
01.31.55TP
Primary DI / UDI-DI
07630030860911
Basic UDI-DI
B-07630030860911
510(k) Number
FDA product code
LPH, LZO
EMDN code
P09088007 Hip prostheses fixing screws
GMDN term
Acetabulum prosthesis hole plug
Device class
Class III EUDAMED
Class II GUDID
Regulation number
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 · 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: Acetabulum prosthesis hole plug

Cleared under the same submission (K103721)

and 8 more cleared under K103721

Similar devices in this category

Other devices filed under HIP PROSTHESES FIXING SCREWS.

Other devices from Medacta International SA

See all devices from Medacta International SA →

Properties

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