If you’ve not seen the test section for our x-series implants, that’s definitely worth a look… but this post is the place where all of our test data on flex devices will be accumulated over time.
Installation safety alert
We do have an updated safety alert for flex implants, so that’s the first thing I want to make everyone aware of. This alert involves the installation of certain flex implants along the knife edge of the hand (position 5).
Lab testing for ISO10993
The following tests were performed for Walletmor products using the VivoKey Flex Biopolymer coating by KONMEX Labs in Poland;
- ISO 10993-1:2018(E), Biological evaluation of medical devices – Part 1: Evaluation and testing
within a risk management process, - ISO 10993-10:2010(E), Biological evaluation of medical devices – Part 10: Tests for irritation
and skin sensitization, - ISO 10993-12:2012(E), Biological evaluation of medical devices – Part 12: Sample preparation
and reference materials, - Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on
the protection of animals used for scientific purposes. - United States Food and Drug Administration, Title 21 Code of Federal Regulations Part 58,
Federal Register 22nd December 1978 and subsequent amendments, - ISO 10993-5:2009(E), Biological evaluation of medical devices – Part 5: Tests for in vitro
cytotoxicity, - ISO 10993-12:2021(E), Biological evaluation of medical devices – Part 12: Sample preparation
and reference materials.
The reports;
Konmex Intracutaneous reactivity test.pdf (391.1 KB)
Konmex Qualitative in vitro cytotoxicity MEM elution.pdf (230.2 KB)
Material robustness
Many people have concerns about both the flex material’s physical robustness, as well as the robustness of the internal components encapsulated by it. There have been many short videos recorded detailing this, but these videos show the most damage, and yet the flex devices come out unscathed… for the most part.
