The Orthopedics Industry FDA clears the first 3D expandable interbody system
FIRST 3D EXPANDABLE INTERBODY SYSTEM CLEARED BY FDA (Orthopedics This Week) K2M Group Holdings, Inc. stakes claim to be the first […]
FDA
ConforMIS to launch 3D-printed hips based on patient-specific technology
FDA clears Conformis’ iTotal hip replacement (MassDevice) ConforMIS (NSDQ:CFMS) said today it won FDA 510(k) clearance for its primary iTotal Hip replacement system.
SI-BONE goes 3D with their new iFuse implant
SI-BONE, Inc. Announces FDA Clearance and Full U.S. Commercial Launch of the iFuse-3DTM Implant, a Patented,
Go US first! may be your best new strategy
Why U.S. first may be the new medical device development strategy (Medical Design & Outsourcing) Increased regulatory hurdles in Europe and China
Trump wants to double device user fees for manufacturers
TRUMP WANTS TO DOUBLE DEVICE USER FEES (Orthopedics This Week) President Trump wants the medical device and pharmaceutical industries to pay
FDA says “NO” to the new robot system from Globus Medical
FDA JILTS GLOBUS ROBOT SYSTEM (Orthopedics This Week) The FDA has informed Globus Medical, Inc. that the agency is not granting
Pro-industry Venture Capitalist is now heading up the FDA
GOTTLIEB SHAKE-UP COMING TO FDA (Orthopedics This Week) The U.S. Senate approved Scott Gottlieb, M.D. as the next FDA Commissioner on
The Ortho industry asks the FDA for 7 wishes
INDUSTRY ID’S TOP GUIDANCE WISH LIST FROM FDA (Orthopedics This Week) Each year, the Food and Drug Administration (FDA) publishes
FDA clears a new 3D Printed Unicompartmental Knee System
© Martin Houde 2016 Bodycad Receives FDA 510K Clearance for Personalized Unicompartmental Knee System (press release) Bodycad website QUEBEC CITY, March
FDA clears NuVasive’s CoRoent Interbody System for 4 levels!
NUVASIVE GETS FIRST FOUR-LEVEL CERVICAL FUSION CLEARANCE (Orthopedics This Week) NuVasive, Inc. announced on March 29, 2017, that it is the
FDA clears extremity implant from Utah startup
FDA CLEARS NOVEL EXTREMITY IMPLANT FROM UTAH START-UP (Orthopedics This Week) See all Extremities Startups Logan, Utah-based extremity implant company, First
FDA clears Intellijoint’s anterior hip low cost navigation system
INTELLIJOINT HIP ANTERIOR RECEIVES FDA CLEARANCE (Orthopedics This Week) Intellijoint Surgical website Canada-based Intellijoint Surgical Inc. has announced the FDA clearance
FDA triggers Zimmer Biomet recall of Reverse Shoulder due to high fracture rate
Zimmer Biomet Recalls Comprehensive Reverse Shoulder due to a High Fracture Rate (FDA) The FDA has identified this as a Class
Shame on the FDA
FORMER FDA DEPUTY DIRECTOR CHARGED WITH INSIDER TRADING (Orthopedics This Week) FDA INSIDER TRADING SUSPECT COMMITS SUICIDE (Orthopedics This Week) The FDA
MẌ Orthopedics Receives FDA Clearance on the dynaMẌ™ Nitinol Compression Screw
MẌ Orthopedics Receives FDA Clearance on the dynaMẌ™ Nitinol Compression Screw (press release) LEXINGTON, Mass., June 7, 2016 /PRNewswire/ — MẌ
New FDA guidance for companies that create 3D-printed implants in Orthopedics
More from the FDA on Material Characterization for Additive Manufacturing (ODTMag) In March, I addressed here recent actions by the FDA
Is transparency the future of research? SI-BONE to share clinical trial data with the world
Transparency in research: SI-BONE to make clinical trial data accessible via Yale YODA Project (YaleNews) With the ultimate goal of fostering
The new FDA Commissioner says “It’ all about the pain”
NEW FDA COMMISSIONER: “IT’S ABOUT THE PAIN” (Orthopedics This Week) If you’re in the business or profession of addressing pain, you’ve
A Spine company launches a new Foot and Ankle product
Centric Medical™ Announces Full Market Release of TARSA-LINK™ Stand-Alone Wedge Fixation System for Foot and Ankle (press release) LIST of 26
Implanet’s Jazz Lock is now cleared in the US and EU
IMPLANET: GREEN LIGHT(S) TO MARKET JAZZ LOCK (Orthopedics This Week) IMPLANET has announced that it has the green light from the
SpineSource launches an expandable lumbar interbody cage in the US
SpineSource Launches Expandable Lumbar Interbody Cage in U.S. (OrthoSpineNews) SpineSource, Inc. announced today the U.S. launch of the L-Varlock Lumbar Cage.
An Overview of the MicroPort PROFEMUR hip recall
MicroPort Orthopedics Profemur Modular Neck Hip Implant Failure Recall (The Legal Examiner) Another metal hip implant fiasco and recall has
What’s the Real Reason for FDA Device Delays?
What’s the Real Reason for FDA Device Delays? (MDDI) You’ve heard of the first mover advantage, but what about a first
Prediction: The FDA will shift to EU model of post-market evaluations
CLINICAL EVIDENCE GATHERING SHIFTING TO POST-APPROVAL (Orthopedics This Week) The U.S. relies on gathering clinical data to show a device is
Case Study: 5 Mistakes that lead to flushing $400,000 in fighting the FDA
How To Flush $400,000 Down the Drain Fighting the FDA (by Jon Speer at Greenlight Guru) How much does it cost
The FDA opens up more information in its Medical Device Database
openFDA Unveils Cache of Medical Device Data (FDA Blog) OpenFDA is releasing information on medical devices that could spur innovation and
Stryker recalls 17,000 extremity devices worldwide
Stryker Recalls Nearly 17,000 Orthopedic Implant Devices (MedScape) Medical device maker Stryker Corporation is recalling 16,992 orthopedic implant devices because of
The FDA will raise med device user fees more than 4%
FDA raises medical device user fees more than 4% (MassDevice) The FDA is raising the user fees medical device makers pay
Your products should be UDI-ready by September
Why You Need a UDI-Ready Line… or Even Better, a Sterile-Packed One (Jérôme Trividic – LinkedIn) read also Ortho Companies challenge the FDA’s
Former CEO of OtisMed sentenced to prison for commercializing products not cleared by FDA
OTISMED’S CHI SENTENCED TO PRISON (Orthopedics This Week) List of Mergers and Acquisitions in Orthopedics Charlie Chi’s profile on LinkedIn Charlie
The FDA answers cybersecurity questions related to medical devices
FDA answers cybersecurity questions (by Joe Hage – Medical Device Marketing Consultant, Medical Devices Group Leader, 10x Medical Device Conference Host)
Regulatory affairs advice for medical device startups
Regulatory affairs for medical device startups (MassDevice) Instilling a robust quality management system as soon as possible is crucial in becoming
FDA approves for the activL artificial disc for one-level lumbar use
Aesculap Receives FDA Approval for the activL® Artificial Disc for One-Level Lumbar Use (press release) Intelligent Motion Technology for Total Disc
Vertiflex wins FDA PMA clearance for Superion Interspinous Spacer
VERTIFLEX’S SUPERION INTERSPINOUS SPACER APPROVED (Orthopedics This Week) The FDA issued a rare PMA Approval Order (pre-market approval) on May 26,
FDA warns Signal Medical on unapproved hip implants
FDA warns Signal Medical on unapproved hip implants (MassDevice) the FDA warning etter The FDA sends a warning letter to Signal
Ortho Companies challenge the FDA’s directive on Unique Device Identifications (UDIs)
UDI Rule a Challenge for Ortho Company (MDDI) Orthopedics company Globus Medical asks FDA to exempt already-distributed implant inventory from the
FDA shuts down sale of Stanmore Knee Implants in the US
STANMORE KNEE IMPLANTS BANNED IN U.S. (Orthopedics This Week) Read the Warning Letter, click here. Extendable femoral and total knee replacement
The Medical Device Industry unveiled an “Innovation Agenda”
DEVICE INDUSTRY LAYS OUT “INNOVATION AGENDA” (Orthopedics This Week) AdvaMed, the medical device industry’s largest trade group, has unveiled an “Innovation
FDA touts progress on demographic information in Clinical Trials
Recent Progress on Demographic Information and Clinical Trials (FDA blog) At FDA, one of our foremost responsibilities is to evaluate and
The 3D Printing Future has arrived! MedShape gains FDA clearance for its 3D printed titanium metatarsal plate
All 3D Printing Articles (OrthoStreams) MEDSHAPE: 510(K) FOR BONE TETHER PLATE (Orthopedics This Week) MedShape, Inc. has announced that the company has
FDA Commissioner Margaret Hamburg resigns
U.S. FDA Commissioner Margaret Hamburg to step down (press release) Dr. Margaret Hamburg, who as commissioner of the U.S. Food and
Japan implements major changes to its Medical Device registration process
Major Changes to Medical Device Registration Process in Japan (Emergo) Revised medical device registration and approval requirements in Japan will become
Wright Medical is close to commercializing the first new growth factor in Orthopedics in a decade – Augment Bone Graft
Wright Medical (WMGI) Reports FDA Approvable of Augment Bone Graft, Lowers FY14 Sales Guidance (StreetInsider) Wright Medical Group, Inc. (NASDAQ: WMGI)
FDA pitches its technology transfer program – grants are available
FDA Invents: How technology transfer gets FDA inventions from lab to marketplace (OrthoSpineNews) If you think the term “government invention” is
Former FDA head says biotech business model ‘is basically falling apart’
Former FDA head says biotech business model ‘is basically falling apart’ (Boston Business Journal) A former head of the U.S. Food
Analysis of FDA’s new 510(k) guidance by the Emergo Group
US FDA publishes insight into 510(k) Substantial Equivalence determination process (MassDevice) New draft guidance from the US Food and Drug Administration
Zimmer recalls over 40,000 NexGen Total Knee Replacements
Your Dashboard for the Zimmer-Biomet Merger OVER 40,000 ZIMMER NEXGEN KNEE TIBIAL COMPONENTS RECALLED (Orthopedics This Week) Zimmer Holdings, Inc. is
Get on FDA’S Cloud
GET ON FDA’S CLOUD (Orthopedics This Week) The FDA’s collective heads are in the clouds when it comes to “Big Data.”
FDA issues two draft guidances on Social Media
Double Trouble: Two New FDA Draft Guidances on Social Media (OrthoSpineNews) Two NEW FDA DRAFT Guidances On the Use of Social
FDA metrics – device fees ups, approvals up, review times down
FDA DEVICE FEES AND APPROVALS UP, REVIEW TIMES DOWN (Orthopedics This Week) Medical device companies paid the FDA $96.8 million in