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Manufacturer of passive middle ear implants, ventilation tubes and precision instruments for ENT surgery

KU

Heinz Kurz GmbH

DusslingenNew on Amplifa

More than 30 yearsActive in the field of passive middle ear implants
GmbHLegal form, HRB 381424 Stuttgart Local Court
DusslingenProduction and administration site (72144 Dusslingen)
bess groupPart of the corporate group
up to 7.0 TeslaDocumented MRI safety of the prostheses as long-term

About Heinz Kurz GmbH

Heinz Kurz GmbH, based in Dusslingen (Baden-Württemberg), has specialized for over 30 years in the development and manufacture of passive middle ear implants, ventilation tubes and special precision instruments for ENT surgery. The product portfolio includes prostheses for tympanoplasty (including TTP-Tübingen, Düsseldorf, Munich and Dresden prostheses), stapes prostheses for stapedectomy (including the Matrix and Nitibond/Nitiflex series) as well as ventilation tubes, instruments and accessories. The ENT range is complemented by an upper eyelid implant for ophthalmology. The manufacture of these filigree-shaped prostheses requires the utmost precision; all products undergo an intensive cleaning process for ultra-clean surfaces as well as strict quality controls including MRI safety testing up to 7.0 Tesla. Development is based on measurement series, clinical evidence and collaboration with national and international scientists and physicians. The company is part of the bess group and is represented worldwide via distribution partners, including its own sales companies in the USA and Japan.

Site
Dusslingen
Processes
Manufacture of passive middle ear implants, ventilation tubes and precision instruments (medical, Intensive cleaning process for all prostheses for clean surfaces, Testing: strict quality controls, MRI safety tests (up to 7.0 Tesla), Research & Development: development of implants based on measurement series, Product training, e-Catalog, Extranet
Materials
Nitinol (Nitibond/Nitiflex stapes prostheses indicate use of Nitinol), Titanium
Certificates
EN ISO 13485, ISO 13485 MDSAP, EU MDR 2017/745 (Manufacturer's Declaration / Notified Body Confirmation), MDD 93/42/EEC Annex II, MDD 93/42/EEC Annex V, EU MDR 2017/745 (Manufacturer's Declaration/Notified Body Confirmation)
Industries
Medical technology, ENT surgery (otology, rhinology, laryngology), Ophthalmology, ENT (otology, rhinology, laryngology)
  1. 01

    Research & Development (measurement series, scientific collaboration)

  2. 02

    Precision manufacturing of implants and instruments

  3. 03

    Intensive cleaning process for all prostheses

  4. 04

    Strict quality controls incl. MRI safety tests

  5. 05

    Worldwide distribution via partners and own sales companies

Materials and Processes

Ti

Titanium

Material for passive middle ear implants and stapes prostheses such as the Nitibond/Nitiflex series (Nitinol-based designs).

Locations

Dusslingen

DE

Headquarters, production and quality control

Materials
Titanium-based implant materials

Industries

Medical technologyENT surgery (otology, rhinology, laryngology)OphthalmologyENT (otology, rhinology, laryngology)

Processes & technical limits

ProcessesToleranceMax. partWeightLot sizeMaterials
Manufacture of passive middle ear implants, ventilation tubes and precision instruments (medicalEngineering–––––
Intensive cleaning process for all prostheses for clean surfacesSurface–––––
Testing: strict quality controls, MRI safety tests (up to 7.0 Tesla)Testing–––––
Research & Development: development of implants based on measurement seriesEngineering–––––

Additional services

Product traininge-CatalogExtranet

Reference customers

Kurz Medical Inc. (USA)Kurz Medical K.K. (Japan)bess medizintechnik gmbhInstrumentarium (Canada)Millennium Surgical Device Inc. (Puerto Rico)

Quality

All prostheses undergo strict quality controls and an intensive cleaning process for maximally clean surfaces. MRI safety tests confirm the suitability of the prostheses as long-term implants up to 7.0 Tesla.

EvidenceDusslingen
EN ISO 13485
ISO 13485 MDSAP
EU MDR 2017/745 (Manufacturer's Declaration/Notified Body Confirmation)
MDD 93/42/EEC Annex II
MDD 93/42/EEC Annex V

History

  1. More than 30 years of experience in the development and manufacture of passive middle ear implants; the company is today part of the bess group.

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