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ProMade 9CC0.13.023

by Limacorporate

Part of a family of 63 devices: see the family page

Ref 9CC0.13.023Model ProMade - Long Stem for Glenosphere Extractor, 80333902A053BV

ProMade 9CC0.13.023 is an orthopaedic inorganic implant inserter/extractor (EU MDR Class I; EU MDR Class IIa; FDA Class II; FDA product code KWS, Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented) made by Limacorporate, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-08033390132664), cleared under FDA 510(k) K110598 on 18 Aug 2011 and listed in FDA GUDID since 29 Apr 2022 (UDI-DI 08033390132664), active as of 7 Nov 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K110598

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/MDR EUDAMED NumberB-08033390132664 Basic UDI-DI 08033390132664UDI-DIDate6 Nov 2026RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-08033390132664 Basic UDI-DI 08033390132664UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033390132664 UDI-DI Date29 Apr 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK110598 Date18 Aug 2011DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08033390132664 registered 6 Nov 2026 Active· +1 more in the status table
  • FDA 510(k) K110598 decided 18 Aug 2011 Active
  • FDA GUDID UDI-DI 08033390132664 listed 29 Apr 2022 Listed

Recalls

1 recall · FDA

    • Terminated Z-1711-2016 FDA Class II initiated 8 Apr 2016

    Complaints of intra-operative breakage of the glenosphere impactors/extractors.

Timeline

4 dated events

  1. Cleared FDA 510(k) K110598
  2. Recall initiated FDA recalls Z-1711-2016
  3. Listed FDA GUDID 08033390132664
  4. Registered EUDAMED B-08033390132664

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
ProMade - Long Stem for Glenosphere Extractor EUDAMED
ProMade GUDID
Generic name
Orthopaedic inorganic implant inserter/extractor, reusable
Model / Ref / Catalog
9CC0.13.023, ProMade - Long Stem for Glenosphere Extractor, 80333902A053BV
Primary DI / UDI-DI
08033390132664
Basic UDI-DI
B-08033390132664, 80333902A053BV
510(k) Number
FDA product code
KWS
EMDN code
L091101 Orthopaedic prostheses and traumatological implants extractors, reusable
GMDN term
Orthopaedic inorganic implant inserter/extractor, reusable
Device class
Class I EUDAMED
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3660
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class I and Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes.

Related devices

Category: Orthopaedic inorganic implant inserter/extractor, reusable

Cleared under the same submission (K110598)

and 8 more cleared under K110598

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES AND TRAUMATOLOGICAL IMPLANTS EXTRACTORS, REUSABLE.

Other devices from Limacorporate

See all devices from Limacorporate →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)