The Regulatory Trap: Why Your Orthopedic Innovation is Stalling (and How to Fix It)
In our industry, we’re great at bending metal, perfecting coatings, and obsessed with “smart” everything. But there is a silent […]
Regulation
What a 510(k) actually costs in 2026… because nobody tells you the real number until you’ve already spent half of it
Guest post by Lisa Voronkova, Founder & CEO of OVA Solutions and author of the “Hardware Bible.” Follow Lisa’s free
How EU MDR Regulations Are Robbing Patients of Proven Orthopedic Implants
In a poignant LinkedIn post that has resonated across the orthopedic community, Robert Clayton, President of the British Orthopaedic Foot
How “Customer Capture” happened in Ortho
Why Read Over time in orthopedics, we have all seen the focus shift away from clinical innovation and patient outcomes
Shame on Aesculap
Shame on Aesculap: A $38.5M Settlement Exposes Device Failures, Kickbacks, and Why Foreign Ortho Giants Hesitate on the U.S. Market
Florida’s bold move may effect Orthopedic healing for elites.
Why read this article? …to discover how Florida’s pioneering legalization of non-FDA-approved stem cell injections is revolutionizing regenerative medicine, attracting
Mastering Ortho Sales in the VAC Era (includes a 14 Step How to Guide)
This could be the most valuable advice given on OrthoStreams this year. As you know, the U.S. healthcare system has
Is Orthopedics a “Locked Up” Market?
A recent conversation sparked a thought-provoking question: Is a significant portion of this market—perhaps as much as 80%—effectively “locked up”?
Funny time! The 10 best FDA 483 excuses.
Sharing Troy Fugate’s LinkedIN posting.. FDA 483 observations require serious, well-documented corrective actions, but some companies have responded with unbelievable
FDA proposing design changes without needing the need of a 510(k).
FDA seeks feedback on predetermined change control plans The guidance describes changes companies can make to medical devices without filing
There’s a new CDRH Director in town ! What will change for orthos ?
CDRH Director Shuren to step down after 15 years Michelle Tarver, deputy director for transformation, will serve as acting director
Moximed MISHA Knee wins FDA clearance, finally.
“After $183M in funding and 17 years of work, and 4 redesigns of the device, Moximed has finally won FDA
FDA clears single-use arthroscope.
FDA clears Pristine Surgical single-use arthroscope (MassDevice) Pristine Surgical announced today that FDA has cleared its Summit 4K single-use surgical
Potential Big News! Germany and French medtech call for 2-year extension of MDR’s transition period
French, German medtech groups call for at least 2-year extension of MDR’s transition period (MedTechDive) Dive Brief: Two of the
25 Ortho Startups to watch this year
https://www.medtechpulse.com/article/infographic/25-orthopedics-startups-to-watch-in-2022 When industry experts discuss the most promising innovation in the context of MedTech, they often refer to trends such
Whoops! Arthrex to pay the DOJ $16M for kickbacks
https://www.justice.gov/opa/pr/medical-device-company-arthrex-pay-16-million-resolve-kickback-allegations Medical Device Company Arthrex to Pay $16 Million to Resolve Kickback Allegations Arthrex Inc., a Florida-based medical device company,
FDA clears AI-driven algorithm diagnosis for knees
Danish Health Startup Radiobotics Receives FDA Clearance for AI-Driven Knee Algorithm (TechTimes) Radiobotics, the Danish health tech startup, has announced
Device makers channel $3B to orthopods
Cited in this article – SpineFrontier, Life Spine, Arthrex, and Exactech Devicemakers have funneled billions to orthopedic surgeons who use
Gutsy move by Spinal Elements. Is this the best time to go public?
Implant system maker Spinal Elements files for $100M Nasdaq IPO (Fierce Biotech) Spinal Elements, maker of a wide range of
Be the first to learn about the new “game changer” material in spine
New materials in orthopedics are rare. “Game Changer” materials in orthopedics are even rarer. ZFuze(TM) is a “game changer” material.
FDA panel drills down on metal implants reactions
FDA panel wants info on metal implant reactions (TMGPulse) An FDA panel will meet this week to discuss immunological responses
Pssss… There is a “game-changer” biomaterial happening in spine.
The material is called ZFUZE. The secret: the team behind ZFUZE has cracked the code on the immune response. Translation: no inflammatory reaction =
A cold reminder, not to play financial games with your Orthopedic company
Ex-ArthroCare CEO Baker loses appeal of 20-year sentence (Mass Device) A federal appeals court this week upheld the 20-year sentence imposed on
Will the FDA ban reusable orthopedic implants?
UNIVERSITY OF TOLEDO PROFESSOR PETITIONS FDA FOR REPROCESSING BAN (Orthopedics This Week) University of Toledo professor has petitioned the FDA
DePuy is willing to pay $400M to settle Metal-on-Metal Hip cases
Report: J&J willing to pay more than $400m to settle Pinnacle hip cases (MassDevice) Johnson & Johnson (NYSE:JNJ) is willing to