Skip to content

Mpact Acetabular System 01.32.158RH

by Medacta International

Ref 01.32.158RH

Mpact Acetabular System 01.32.158RH is a device classified as Class III in the EU and Class II in the US made by Medacta International, registered in EUDAMED on 15 Oct 2026 (Basic UDI-DI B-07630030810916), cleared under FDA 510(k) K250450 on 19 Sep 2025 (1 earlier submission) and listed in FDA GUDID since 18 Nov 2014 (UDI-DI 07630030810916), active as of 24 Oct 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K250450

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07630030810916 Basic UDI-DI 07630030810916UDI-DIDate15 Oct 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK250450 Date19 Sep 2025DecidedStatusActive
United StatesGUDID listing GUDID Number07630030810916 UDI-DI Date18 Nov 2014ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07630030810916 registered 15 Oct 2026 Active
  • FDA 510(k) K250450 decided 19 Sep 2025 Active· +1 more in the status table
  • FDA GUDID UDI-DI 07630030810916 listed 18 Nov 2014 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K132879
  2. Listed FDA GUDID 07630030810916
  3. Cleared FDA 510(k) K250450
  4. Registered EUDAMED B-07630030810916

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  • Withdrawn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
Acetabular shell Ø58 Rim-hole EUDAMED
Mpact Acetabular System GUDID
Generic name
Acetabular shell
Device name
Hip Mpact Acetabular shell
Model / reference
01.32.158RH
Primary DI / UDI-DI
07630030810916
Basic UDI-DI
B-07630030810916
510(k) Number
FDA product code
LPH, LZO
EMDN code
P090803010201, P0908030302
GMDN term
Acetabular shell
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: Acetabular shell

Cleared under the same submission (K132879)

and 8 more cleared under K132879

Cleared under the same submission (K250450)

and 8 more cleared under K250450

Similar devices in this category

Other devices filed under PRIMARY IMPLANT UNCEMENTED METAL ACETABULAR CUPS.

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)