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Vario-Cup System

by WALDEMAR LINK GmbH & Co. KG

510(k) K221794Ref 99-0055/55, 107-220/57, 107-220/58, 107-230/59, 99-0055/50, 107-230/65, 107-220/45, 107-230/56, 107-230/62, 99-0055/44, 99-0055/52, 107-220/61, 99-0055/45, 107-230/51, 107-230/49, 107-220/50, 99-0055/40, 107-220/60, 107-220/56, 107-200/22, 107-220/49, 107-230/63Model Bipolar head, uncemented, CoCrMo, UHMWPE, Safety ring, uncemented, UHMWPE

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

CE MDR 510(k)

Valid until

9 Jul 2029

CE MDR certificate

FDA recalls

None found

in data synced 22 Oct 2026

Documents

1 certificate

Certifier DNV MEDCERT GmbH

510(k) K221794↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4026575-1-HSP-034001-X7 Basic UDI-DI Date12 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK221794 Date20 Jul 2022ClearedStatusActive
United StatesGUDID listing GUDID Number04026575329601 UDI-DI Date1 Nov 2015ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 13794GB450240710 Active

    Technical documentation EU MDR

    Certifier
    DNV MEDCERT GmbH 0482
    Issued
    10 Jul 2024
    Expires
    9 Jul 2029

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade Name
LINK Vario-Cup Prosthesis
Vario-Cup System
Generic Name
Bipolar femoral head outer component, hemiarthroplasty
Model / Ref / Catalog
107-220/56, 99-0055/40, 107-230/65, 107-200/22, 107-220/58, 107-220/60, 107-230/59, 107-230/51, 107-220/45, 107-230/62, 107-220/57, 107-220/49, 107-230/63, 107-220/61, 107-220/50, 107-230/49, 107-230/56, Bipolar head, uncemented, CoCrMo, UHMWPE, 99-0055/55, 99-0055/50, 99-0055/44, 99-0055/52, 99-0055/45, Safety ring, 107-230/61, 107-220/46, 107-230/52, 107-220/54, 107-230/58, 107-200/32, 107-230/64, 107-230/60, 107-220/44, 107-220/51, 99-0055/41
Primary DI / UDI-DI
04026575329601, 04026575352760, 04026575329939, 04026575395910, 04026575329625, 04026575329649, 04026575329878, 04026575329793, 04026575328185, 04026575329908, 04026575329618, 04026575328291, 04026575329915, 04026575329656, 04026575328314, 04026575329779, 04026575329847, 04026575352913, 04026575352869, 04026575352807, 04026575352883, 04026575352814, 04026575329892, 04026575328239, 04026575329809, 04026575328604, 04026575329861, 04026575395903, 04026575329922, 04026575329885, 04026575328208, 04026575328222, 04026575352777
Basic UDI-DI
4026575-1-HSP-034001-X7, 4026575-1-HSP-034002-XA
510(k) Number
FDA Product Code
KWY
EMDN Code
P0908040503, P09088099
GMDN Term
Bipolar femoral head outer component, hemiarthroplasty
Device Class
Class III EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 888.3390
EU market of registration
Germany
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 2 fields differ

FieldEUDAMED510(k)GUDID
Device ClassEUDAMED
Class III
510(k)
Class II
GUDID
Class II
Contains LatexEUDAMED
No
510(k)
—
GUDID
No
Yes

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Vario-Cup System is a modular orthopedic implant designed for use in total hip arthroplasty. It features a customizable acetabular component that allows for precise fitting and alignment during surgical reconstruction of the hip joint, ensuring stability and long-term function.

This system is supplied sterile and intended for single-use. It is classified under the MDR and granted FDA 510(k) clearance with a Special 510(k) designation, reviewed by the Orthopedic Devices Advisory Committee. The modular components are intended for use in controlled surgical environments, adhering to standard aseptic techniques, and are available in various sizes to accommodate different patient anatomies.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of patients is the Vario-Cup System designed to accommodate in terms of anatomical differences?

    The Vario-Cup System is designed with modularity in mind, offering various sizes to match different patient anatomies during total hip arthroplasty. This customizable acetabular component allows surgeons to achieve precise fitting and alignment, ensuring stability and long-term function for a broader range of patients.

  • Is the Vario-Cup System intended for reuse or is it meant to be used only once per patient?

    The Vario-Cup System is explicitly intended for single-use only, as stated in its specifications. This ensures patient safety and sterility, requiring adherence to standard aseptic techniques during surgical procedures.

  • How is the Vario-Cup System supplied, and what does this mean for surgical preparation?

    The Vario-Cup System is supplied sterile, which means it is pre-sterilized and ready for immediate use in a controlled surgical environment. This eliminates the need for additional sterilization steps before surgery, streamlining the preparation process.

  • What regulatory pathways has the Vario-Cup System undergone, and what does this imply for its use?

    The Vario-Cup System has received FDA 510(k) clearance with a Special designation, reviewed by the Orthopedic Devices Advisory Committee, and complies with the Medical Device Regulation (MDR). This implies it meets stringent regulatory standards for safety and effectiveness in orthopedic applications, specifically for total hip arthroplasty.

Properties

  • Sterile
  • Single Use
  • Implantable
  • Contains Latex NoEUDAMEDGUDIDYesGUDID
  • CMR Substance YesEUDAMEDNoEUDAMED
  • Prescription Use
  • Lot / Batch Number NoGUDIDYesGUDID
  • Serial Number YesGUDIDNoGUDID
  • Expiration Date

Other properties (15)

  • Reusable: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Manufacturing Date: No