The Orthopedics Industry A new tool for Engineers… a bone quality FEA
The Technology Based on a proprietary “particle-based” model of bone tissue, the Lifespans Bone Simulator is the world’s first practical […]
FDA
What? The FDA issues safety warning for STAR Ankle after 23 years of clinical history.
The STAR Ankle has early poly fracture issues, so the FDA issued a warning (scrolll down for FDA statement). How
FDA is playing catchup, releases an “action plan” for AI/ ML in medical devices
Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan (FDA website PDF) Tiger’s take-home message: The FDA
Uni knee pulled from market because of high aseptic loosening rates
B. Braun halts certain Aesculap knee implants (MassDevice) B. Braun’s Aesculap Univation X knee system B. Braun is notifying customers who
Spineology wins clearance for OptiMesh expandable IB fusion system
Spineology® Announces FDA De Novo Grant of Minimally Invasive OptiMesh® Expandable Interbody Fusion System (press release) –Spineology Inc., an innovator in anatomy-conserving
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.
What happened to orthopedic FDA panel meetings?
THE VANISHING FDA ORTHO PANEL MEETING (Orthopedics This Week) In the last few years the ortho panel meeting has gone
STAR total ankle replacements at 8 years have a 14% poly fracture rate. Safety notice issued.
Stryker warns of plastic fracture problem with STAR total ankle replacement (MassDevice) Stryker (NYSE:SYK) recently issued a safety notice involving its
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
New guidance from FDA on software in orthopedics.
HOW WILL THE FDA REGULATE MEDICAL DEVICE SOFTWARE? (Orthopedics This Week) The FDA wants to be crystal clear about how
OrthoSpin wins FDA clearance for its smart Ex-Fix system
OrthoSpin Receives FDA Regulatory Clearance (press release) OrthoSpin Ltd. a portfolio company of The Trendlines Group Ltd. (“Trendlines”) (SGX: 42T) (OTCQX: TRNLY),
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 =
Vertebral Body Tethering to become a mainstream Scoliosis Treatment
FDA Approval Recognizes Vertebral Body Tethering as a Mainstream Scoliosis Treatment (TMG Pulse) FDA Description of The Tether A first-of-its-kind
The short history of Titan Spine from 2006 to 2018
Titan Spine ‘turns it to eleven’ (BizTimes) With a proprietary surface technology and a runway of private equity investment, Titan Spine
Have government scientists solved the artificial hips corrosion problem?
Have government scientists solved the artificial hips corrosion problem? (TMG Pulse – Released on August 8, 2019 | Written by
Finally, Annular Closure is being used in the US, again
FINALLY, ANNULAR CLOSURE IS BEING USED IN THE U.S., AGAIN (Orthopedics This Week) Barrachaid website More than 500 patients have
Hintermann Total Ankle wins rare FDA clearance
HINTERMANN ANKLE REPLACEMENT RECEIVES RARE FDA APPROVAL (Orthopedics This Week) After almost three years of FDA review, DT MedTech, LLC
FDA recall of Brainlab software used in spinal navigation
BRAINLAB ISSUES CLASS 1 RECALL OF ITS SPINAL NAVIGATION SOFTWARE (Orthopedics This Week) Definition: A Class I Recall is a situation in which
Intellirod Spine Receives First-Ever Spine FDA De Novo Approval
Intellirod Spine Receives First-Ever Spine FDA De Novo Approval (press release) MCRA Assists Intellirod Spine™ with 1st ever Spine De
The ROSA Robot system is cleared in the US for spine
Zimmer Biomet Receives FDA Clearance for Robotic ROSA One Spine System (press release) Zimmer Biomet becomes first company in the
Molecular Matrix brings ‘Next Generation’ Bone Regenerative Technology to orthopedics
Molecular Matrix Brings ‘Next Generation’ Bone Regenerative Technology to the Market (press release) SMolecular Matrix, Inc. (“MMI”), is a California
Brilliant! OrthoGrid solves the C-arm distortion problem
OrthoGrid Systems’ PhantomMSK™ Platform Receives FDA 510(k) Clearance for Novel Distortion Adaptation Technology in Orthopedic Surgery (press release) OrthoGrid Systems,
Is Cervical Disc Arthroplasty still “experimental” ?
CERVICAL DISC ARTHROPLASTY NOT “EXPERIMENTAL.” WELL, YEAH. (Orthopedics This Week) Why is the most studied spinal implant in history considered to be “experimental”?
Zimmer recalls Biomet spine stimulators because of poor validations
Zimmer Biomet recalls spine fusion, bone growth stimulators (MedTechDive) Dive Brief: Zimmer Biomet is recalling 1,360 of its implantable spine fusion
Are you sure you have a the right Notified Body?
Written by Joe Hage in the MedicalDevicesGroup on LinkedIn You know that nice, little Medical Device Directive (the MDD) you’ve
Histogenics gambles on an FDA clearance with a missed end point
STRONG DATA FROM DISAPPOINTING NEOCART TRIAL (Orthopedics This Week) So close, they were … Histogenics Corporation, that is. When it comes
Warning! High revision rates with Smith & Nephew Journey BCS knees
Smith & Nephew warns on first-gen Journey BCS knee revision rate (MassDevice) Smith & Nephew (NYSE:SNN) recently released an urgent field
A brand new SI Joint Fusion System is cleared by the FDA
Press Release from Tenon Medical Website -Tenon Medical NEW SI JOINT FUSION SYSTEM CLEARED (Orthopedics This Week) There’s another sacroiliac joint
Finally. The 1st and only “De Novo” clearance in orthopedics is granted to IlluminOss
IlluminOss Medical Granted FDA Marketing Clearance for the IlluminOss® Bone Stabilization System (press release) IlluminOss Medical, a privately held, commercial-stage medical
Sports Med startup wins FDA clearance for new meniscus repair system
Arcuro Medical Website Arcuro Medical Receives FDA Regulatory Clearance (press release) MISGAV, Israel, June 18, 2018 /PRNewswire/ — Arcuro Medical Ltd. (“Arcuro”), a portfolio company of The Trendlines
Stryker issues safety notification for hip system
STRYKER SAFETY NOTIFICATION FOR CERTAIN FEMORAL HEADS (Orthopedics This Week) Stryker Orthopedics issued a Product Safety Notification related to the company’s
Exactech launches stemless shoulder with bone cage fixation
EXACTECH STEMLESS SHOULDER CLEARED (Orthopedics This Week) Gainesville, Florida-based Exactech, Inc. has received 510(k) clearance from the FDA for a stemless
Globus Medical lunges into the Trauma market with 11 new products
Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, is pleased to announce its entry into the orthopedic trauma market. Globus Medical has
Can 3D-printing revolutionize Orthopedics?
Can 3D Printing Revolutionize Orthopaedic Devices? (AAOS) FDA guidance is a first step 3D printing promises to be a revolution in
IlluminOss wins “de novo” clearance for bone stabilization system with help from MCRA
IlluminOss Medical wins de novo nod from FDA for bone stabilization system (MassDevice) MCRA Assists IlluminOss Medical with Successful De Novo
Problems with PFJ implants with new recalls from Zimmer and DePuy
Revision rates prompt recalls for Johnson & Johnson’s DePuy Synthes, Zimmer Biomet (MassDevice) High revision rates for orthopedic implants prompted recalls
Zimmer Biomet stem-free shoulder cleared by FDA
Zimmer Biomet wins FDA nod for Sidus stem-free shoulder system (MassDevice) Zimmer Biomet (NYSE:ZBH) said today it won FDA clearance for its
New FDA guidelines you need to know for 2018
Must-Know FDA Guidance Documents from 2017 (MD&DI) FDA puts out a lot of information over the course of a year.
FDA says “no” to Barricaid for partial annulus replacement in patients with herniated discs
INTRINSIC LOSES FDA VOTE FOR ANNULAR CLOSURE DEVICE (Orthopedics This Week) Even before the committee voted, it was not looking good
In2Bones introduces the first “see through” fixation in a forefoot plate
In2Bones Announces FDA Clearance of the CoLink® View “See-Through” Plating System (press release) In2Bones Global, Inc. today announced that its In2Bones
New Total Ankle Replacement cleared in the US
HINTERMANN H2 ANKLE REPLACEMENT CLEARED IN U.S. (Orthopedics This Week) The Hintermann Series H2 Total Ankle Replacement System (H2) manufactured by
FDA clears the way for IM fixation in Extremities
See my interview with Wade Fallin HERE FDA CLEARS WAY FOR INTRAMEDULLARY FIXATION FOR EXTREMITIES (Orthopedics This Week) Wade Fallin, the
The new FDA user fees are a heavy tax on startups
The FDA has just increased user fees. $10,000 for a 510(k) application even if it is denied. What? Four
Does the US really want less invasive spine technologies?
Does the US really want less invasive spine technologies? (LinkedIn article written by David Hooper, Founder and CEO of Minimus
Spine startup bootstraps a 3D printed cervical implant with two materials
FDA CLEARS OSSEUS’ CERVICAL IMPLANT (Orthopedics This Week) website – http://www.osseus.com/ On July 3, 2017, the FDA cleared Osseus Corporation’s new
Novel total hip design initiates clinicals in the US
website – http://hipinnovationtechnology.com/ Hip Innovation Technology Initiates Clinical Trial of its Novel Hip Replacement System for the Treatment of Total
Premia Spine kicks off posterior arthroplasty device study
PREMIA SPINE LAUNCHES TOPS IDE STUDY (Orthopedics This Week) more info on TOPS Philadelphia, Pennsylvania-based Premia Spine, Ltd. has announced the
Tyber Medical Receives wins clearance for its TyFix™ All-in-One Extremity Joint Fixation Device
Tyber Medical Receives 510 (k) clearance for TyFix™ All-in-One Extremity Joint Fixation Device (press release) Tyber Medical, LLC, a privately held
The Potential FDA Impact of the 2018 Presidential Budget Request
Introduction Innovation is a main driver of every industry. This is especially true for medical device companies which, in conjunction
The FDA to use AI to accelerate device evaluations
FDA JUMPS ON AI BANDWAGON (Orthopedics This Week) The FDA is going high tech. According to Evan Sweeney, a writer for MedTech,