Guidance for unique device identifier labeling of convenience kits has been of particular interest to orthopedic manufacturers. FDA's new recommendations include several orthopedic examples of ways that combined products may or may not be considered convenience kits.
Continue reading
Mr. Theken, founder of a mechanical testing lab, five orthopedic device companies and now a contract manufacturing firm, shares his valuable insights for success in the industry.
Continue reading
Almost every orthopedic implant and instrument is at least partially fabricated on a mill, so understanding its use is valuable to all design engineers.
Continue to the article
So far in 2019, funding has driven R&D and regulatory activity for companies working to get their first product on the market, as well as those seeking to expand globally. We look at nine companies with novel technologies that have boosted their capital through outside investments.
Keep reading
We're detailing the five winners of the National Capital Consortium for Pediatric Device Innovation's pitch competition who received a monetary prize in grant funding, as well as access to an accelerator program led by MedTech Innovator.
Learn more about each winner
NanoBone was tested without addition of autograft or bone marrow aspirate in an animal model, and its fusion rate was found to be equivalent to the gold standard of autograft.
Continue reading
Libertas is available in the U.S. and offers a set of modular bone-preserving implants to support stable restoration of hip biomechanics across a range of patient demographics.
Learn more
This paper offers guidance on practical aspects of the large undertaking that is implementation, and highlights major regulation changes focusing on scope, new product development, quality management systems, postmarket surveillance, labeling and more.
Continue to White Paper
