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PolarisAR Completes First Procedure with Stellar Knee
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Spine/Neurology
SetPoint Medical Awarded FDA Breakthrough Nod to Treat Multiple Sclerosis
The company hopes to use its novel neuroimmune platform for people with relapsing-remitting multiple sclerosis
Sam Brusco, Associate Editor
03.18.24
Spine/Neurology
FDA Grants Breakthrough Device Designation to Bioretec's Interbody Cage
The company's RemeOs implants are absorbed and replaced by bone, which eliminates the need for removal surgery.
Michael Barbella, Managing Editor
03.18.24
Spine/Neurology
ONWARD Medical's ARC-BCI Accepted to FDA TAP Program
The company is one of the first brain-computer interface entrants accepted into this program.
Sam Brusco, Associate Editor
03.11.24
Biologics
FDA OKs SurGenTec's Hydrophilic Synthetic Bone Graft
OsteoFlo HydroPutty features a combination of proprietary hydrophilic carriers to absorb fluids.
Sam Brusco, Associate Editor
03.07.24
Instruments
Medtronic Wins FDA Nod for OsteoCool 2.0 Bone Tumor Ablation
OsteoCool 2.0's new design allows the use of four internally cooled probes at the same time.
Sam Brusco, Associate Editor
03.04.24
Spine/Neurology
ONWARD Wins 10th FDA Breakthrough Nod for Brain-Computer Interface
The award gives priority U.S. regulatory review to the company’s ARC-BCI system.
Sam Brusco, Associate Editor
02.29.24
Spine/Neurology
Woven Ortho Gets FDA OK for Larger Ogmend Size
The screw fixation implant is now available for most pedicle screw diameters.
Sam Brusco, Associate Editor
02.29.24
Zimmer Biomet ROSA Shoulder System Receives FDA Clearance
The system becomes the first-to-market robotic surgical assistant for shoulder arthroplasty.
Rachel Klemovitch, Assistant Editor
02.22.24
Spine/Neurology
Wandercraft Receives Second FDA Clearance for its Self-Balancing Exoskeleton
The company’s second FDA clearance in less than a year now indicated for rehabilitation in patients with spinal cord injuries.
Rachel Klemovitch, Assistant Editor
02.16.24
Trauma/Sports
FDA OKs Tyber Medical's Proximal Tibia Plating System
The treatment for complete and articular fractures features single and multiple component metallic bone fixation.
Sam Brusco, Associate Editor
02.12.24
FDA Looks to Industry for Collaboration and Harmonization
The FDA will no longer be a member of the Global Harmonization Working Party (GHWP).
Rod Mell, Executive Head—Medical Devices, Regulatory Compliance Associates
02.05.24
Spine/Neurology
FDA Approves Theradaptive IDE Phase I/II Clinical Trials
Study to assess efficacy and safety of the company’s OsteoAdapt SP spinal fusion product.
Rachel Klemovitch, Assistant Editor
02.02.24
FDA Clears IlluminOss's New Light Console for Implants
The new light-emitting diode console reduces curing time by up to 50%.
Michael Barbella, Managing Editor
02.01.24
Spine/Neurology
SI-BONE Gets FDA OK for Smaller iFuse Bedrock Granite Implant
The 9.5 mm implant also gained expanded indications for pediatric patients and an application for use in the S1 trajectory.
Sam Brusco, Associate Editor
01.31.24
Extremities
Tyber Wins FDA Nod for Mini-Frag System Line Extension
The Mini-Frag system’s line extension includes 1.3 mm screws and plates, expanding its range of sizes.
Sam Brusco, Associate Editor
01.29.24
Trauma/Sports
FDA OKs Able Medical's Valkyrie RIB for Thoracic Repair
The PEEK-based Valkyrie RIB, according to the company, helps minimize patient stress shielding.
Sam Brusco, Associate Editor
01.25.24
Instruments
|
Large Joint
Enhatch Earns FDA Nod for AI-Powered TKA Patient-Specific Instrumentation
The system features AI algorithms that convert patient X-rays or CT images into detailed, 3D anatomic models
Sam Brusco, Associate Editor
01.24.24
Spine/Neurology
FDA Clears Curiteva’s Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion System
The novel platform promotes osseointegration, improves radiographic assessment, and delivers superior biomechanics.
Charles Sternberg, Associate Editor
01.22.24
Biologics
Bone Health Technologies’ Osteoboost Cleared by FDA
The wearable device is indicated to reduce bone strength and density decline in postmenopausal women and is designed to improve bone health during osteopenia.
Charles Sternberg, Associate Editor
01.18.24
Spine/Neurology
Abbott Wins FDA MRI Labeling Approval for Proclaim DRG
Patients implanted with Proclaim DRG can now receive full-body MRI scans.
Sam Brusco, Associate Editor
01.18.24
Extremities
FDA Warns of Possible Equinoxe Shoulder Implant Wear and Tear
Defective packaging could cause the Exactech implants to degrade faster over time.
Sam Brusco, Associate Editor
01.17.24
3Spine Completes FDA Clinical Trial Enrollment
The company achieved 325 surgeries in 2023.
Rachel Klemovitch, Assistant Editor
01.11.24
Spine/Neurology
FDA OKs Providence Medical's CAVUX FFS-LX Lumbar Facet Fixation
The fixation system was cleared for 1- and 2-level lumbar spinal fusions.
Sam Brusco, Associate Editor
01.10.24
Large Joint
FDA: Do Not Use Synovo Total Hip Resurfacing System
Modifications not cleared by the FDA were made to devices manufactured after 2019.
Sam Brusco, Associate Editor
01.04.24
Biologics
CGBio Nets FDA Breakthrough Nod for Novosis Putty
Novosis putty is an advanced bone substitute material that incorporates recombinant bone morphogenetic protein 2 (rhBMP-2).
Sam Brusco, Associate Editor
01.03.24
Extremities
|
Trauma/Sports
Tyber Medical's Distal Radius Plates Gain FDA Nod
The plates maintain stability and orientation in the anteroposterior plane using a dynamic grouping of plate length options.
Sam Brusco, Associate Editor
12.18.23
Trauma/Sports
OSSIOfiber Scores FDA OK to Fix Bone Fractures in Children
OSSIOfiber compression screws and trimmable fixation nails can now be used in children aged two to 21 in standard clinical practice.
Sam Brusco, Associate Editor
12.06.23
Extremities
|
Imaging
ExactechGPS Ankle Surgical Navigation System Nabs FDA Nod
The company said GPS Ankle is the world’s first surgical navigation system for total ankle arthroplasty.
Sam Brusco, Associate Editor
12.06.23
Imaging
|
Large Joint
FDA OKs PolarisAR's Stellar Knee Mixed Reality Surgical Guidance
Stellar Knee uses mixed reality displays to guide total knee replacement.
Sam Brusco, Associate Editor
11.03.23
Spine/Neurology
FDA Clears FloSpine's KeyLift Expandable Interlaminar Stabilization System
KeyLift is the fifth FDA-approved product developed by FloSpine and invented at the Research Park at Florida Atlantic University.
Michael Barbella, Managing Editor
11.02.23
Large Joint
|
MIS/Robotics
Corin's Apollo Surgical Robotics Platform Gains FDA Nod
The company said the Apollo platform goes beyond personalized alignment of the knee during surgery.
Sam Brusco, Associate Editor
11.01.23
Spine/Neurology
Xēnix's SOLACE SI Fixation with NANOACTIV Gains FDA Nod
SOLACE is comprised of 3D printed, threaded implants with a micro and nano-roughened surface.
Sam Brusco, Associate Editor
10.31.23
Large Joint
FDA OKs Exactech's New 3D-Printed Vantage Ankle Tibial Implants
The Vantage Ankle 3D and 3D+ offer further tibial height options for total ankle replacements.
Sam Brusco, Associate Editor
10.30.23
Spine/Neurology
VySpine Earns Trio of FDA Nods for VySpan, VyLam, and VyLink
The trio of clearances expands VySpine’s growing product portfolio.
Sam Brusco, Associate Editor
10.18.23
Spine/Neurology
FDA OKs MiRus' MoRe Anterior Cervical, Lateral Lumbar Plates
The company claims both are the narrowest and thinnest plating systems among all plates on the market.
Sam Brusco, Associate Editor
10.18.23
Software & Quality
NASS News: VUZE 2.0 Submitted for FDA 510(k) Filing
The new, investigational version of the VUZE System will be featured prominently at NASS 2023.
Charles Sternberg, Associate Editor
10.13.23
Spine/Neurology
FDA Clears Orthofix's OstoCove Bioactive Synthetic Graft
OsteoCove features a specialized granule surface topography designed to elicit a bone-forming response.
Michael Barbella, Managing Editor
10.12.23
Extremities
FDA OKs DePuy Synthes' TriLEAP Lower Extremity Plating System
The TriLEAP system was cleared for forefoot, midfoot, and hindfoot elective and trauma surgeries.
Sam Brusco, Associate Editor
10.11.23
Extremities
Intelivation's Hammerdesis Interphalangeal Fusion System Gains FDA Nod
The operation, according to Intelivation, saves intraoperative time and yields cost savings in the ambulatory surgical setting.
Sam Brusco, Associate Editor
10.10.23
Coatings/Surface Modification
|
Spine/Neurology
Xēnix Gets FDA OK for NANOACTIV Nanotech Surface
The company received nanotechnology designation for its neoWave interbody fusion implants.
Sam Brusco, Associate Editor
10.10.23
Extremities
FDA OKs tmCMF Solution for Reconstructive Surgery
tmCMF is a collection of personalized products for trauma and reconstruction procedures in the mandible and midface.
Sam Brusco, Associate Editor
10.10.23
Large Joint
ZKR Ortho's LIFT Implant Granted FDA Breakthrough Status
The LIFT implant was designed to decrease pain, improve function, and delay or remove the need for knee replacement.
Sam Brusco, Associate Editor
10.10.23
Instruments
|
Spine/Neurology
DePuy Synthes Earns FDA Nod for TriALTIS Technology
TriALTIS includes a spine system and navigation-enabled instruments.
Sam Brusco, Associate Editor
10.09.23
Trauma/Sports
FDA OKs Acuitive's Resorbable CITRELOCK DUO to Repair Bicep Tears
CITRELOCK DUO’s biomimetic material composition matches native bone’s inorganic content.
Sam Brusco, Associate Editor
09.28.23
Spine/Neurology
FDA Clears 4WEB Medical's New Integrated Cervical Plate
The Cervical Spine Truss System Integrated Plating Solution provides an additional stand-alone treatment option for customers.
Michael Barbella, Managing Editor
09.28.23
Spine/Neurology
ZimVie's Mobi-C Hybrid Gains IDE Approval From the FDA
Decision allows company to begin enrolling U.S. patients in a clinical study of cervical arthroplasty adjacent to fusion.
Michael Barbella, Managing Editor
09.26.23
Spine/Neurology
FDA OKs Standalone Indication for ChoiceSpine's Blackhawk Ti Cervical Spacer
Blackhawk Ti touts the company’s proprietary BioBond 3D-printed titanium porous structure.
Sam Brusco, Associate Editor
09.20.23
Trauma/Sports
Stryker's Pangea Systems Earn FDA Nod
The Pangea systems include variable-angle plating and instruments for femur, fibula, tibia, humerus, and utility.
Sam Brusco, Associate Editor
09.12.23
Extremities
|
Trauma/Sports
FDA OKs OrthoPediatrics' PNP Tibia Surgical System
The system includes 7-12 mm diameter rigid, cannulated nails to treat lower extremity fractures and deformities in pediatric patients.
Sam Brusco, Associate Editor
09.12.23
Large Joint
|
Materials
FDA OKs Exactech's Activit-E Knee Replacement Polyethylene
This technology addresses the looming shortage of gamma radiation for crosslinking.
Sam Brusco, Associate Editor
08.21.23
Breaking News
Anika Releases Q4 and Year-End 2023 Financial Results
SetPoint Medical Awarded FDA Breakthrough Nod to Treat Multiple Sclerosis
PolarisAR Completes First Procedure with Stellar Knee
FDA Grants Breakthrough Device Designation to Bioretec's Interbody Cage
ODT's Most-Read Stories This Week—March 16
View Breaking News >
CURRENT ISSUE
January/February 2024
Pure Packs: Discussing Ortho Device Packaging & Sterilization
Ortho Instrument Manufacturers Are Developing Surgical Support
Looking Over the Shoulder Replacement Market
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