Ilium

Nevro Receives FDA 510(k) Clearance to Use SI Fixation System Without Need to Include Lateral Screw

Retrieved on: 
Wednesday, February 28, 2024

REDWOOD CITY, Calif., Feb. 28, 2024 /PRNewswire/ -- Nevro Corp. (NYSE: NVRO), a global medical device company delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced that the U.S. Food and Drug Administration (FDA) cleared its sacroiliac joint fusion device, which will be marketed as Nevro1, without the need to include the screw ("NevroFix™").

Key Points: 
  • Nevro1, an integrated transfixing technology, is proven to immediately transfix the SI joint to allow the opportunity for long-term fusion.
  • Self-contained, deployable titanium anchors transfix the sacrum and ilium to enhance axial and rotational stability of the joint.
  • In addition, Nevro's proprietary instrumentation allows for optimal intra-articular SI joint preparation which is critical to achieve joint fusion.
  • The company encourages investors and potential investors to consult the Nevro website regularly for important information about Nevro.

How long did Neanderthals and modern humans co-exist in Europe? Evidence is growing it may have been at least 10,000 years

Retrieved on: 
Tuesday, February 6, 2024

The idea that two different human species, Homo sapiens (us) and Neanderthals, co-existed in western Eurasia 50–40,000 years ago has long captured the imagination of academics and the public alike.

Key Points: 
  • The idea that two different human species, Homo sapiens (us) and Neanderthals, co-existed in western Eurasia 50–40,000 years ago has long captured the imagination of academics and the public alike.
  • It is therefore not surprising that this time period – the Middle-to-Upper Palaeolithic transition – has been a focus of research for many archaeologists, physical anthropologists and, more recently, geneticists.
  • Human skeletal remains are comparatively rare, with many of the best-known fossils having been excavated under less than ideal conditions in the 19th and early 20th centuries.

Major revisions

  • This means the smallest amounts of more recent contamination from the burial environment, or from museum conservation materials, can make dating finds from these sites extremely challenging.
  • This has resulted in major revisions to the chronology of early human occupation over the past decade, shifting some dates on Neanderthal and modern human remains by many thousands of years.
  • This is obviously crucial to the debate, since it is impossible to speak of overlap or replacement without a robust chronology.
  • These teeth came from the same sediment levels as the human remains.
  • The results place the people in a particularly cold snap around 45–43,000 years ago.
  • The H. sapiens remains are associated with what was previously considered an ambiguous stone tool industry (a particular way of making tools) called the Lincombian–Ranisian–Jerzmanowician (LRJ).

Mystery toolmakers

  • Most notable is the Châtelperronian of southern France and northern Spain: do the Neanderthal remains accompanying some of these “modern-looking” tool industries mean they were the toolmakers, or is the association fortuitous?
  • Most caves with Palaeolithic deposits saw intermittent occupation, often by both Neanderthals and H. sapiens, over millennia.
  • The dates for the levels under consideration still span several millennia, during which there may well have been short-term visits by both camps.

New archaeological techniques

  • The results from Ranis, as well as contributing important new data to our understanding of the Middle-Upper Palaeolithic transition, highlight the contributions of recent developments in archaeological science.
  • This technique was also applied to the site’s fauna in another companion paper.
  • Then, relatively high-precision radiocarbon dates were obtained for both the sediment level and the human remains themselves.
  • But most importantly for the question at hand, ancient DNA analysis – in this case, mitochondrial DNA (mtDNA) – confirmed the identification as H. sapiens.


Rick Schulting does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

Sacrix Provides Safe Alternative to Risky Revision Spine Surgery, Publishing Groundbreaking Results in Renowned Spine Journal

Retrieved on: 
Sunday, January 7, 2024

BURLINGTON, Mass., Jan. 6, 2024 /PRNewswire-PRWeb/ -- The article, titled "Salvage of failed direct lateral sacroiliac joint fixation using a new percutaneous lateral-oblique transfixation technique with two variable-threaded screws," promises to redefine the realm of sacroiliac joint surgeries.

Key Points: 
  • Sacrix, a pioneer medical device company in outpatient spine surgery solutions, proudly unveils a novel Less Exposure Spine Surgery (LESS) technique that helped patients avoid major and risky revision corrective spine surgery.
  • The clinical results were summarized in a research paper authored by Board-certified Orthopedic Spine surgeons and published through a premiere peer-reviewed scientific clinical journal.
  • Dr. Richard Francis, a pioneering spine surgeon in Houston, Texas, stated, "the Sacrix technique and device is the best option for this problem."
  • The Sacrix technique offers immediate stability and documented long-term fusion, marking a significant advancement in outpatient orthopedic spine surgery.

Spinal Simplicity Announces 510(K) FDA Clearance of Its Novel Sacroiliac Joint System, the Liberty-SI Lateral Implant

Retrieved on: 
Monday, December 11, 2023

OVERLAND PARK, Kan., Dec. 11, 2023 /PRNewswire-PRWeb/ -- Today, Spinal Simplicity is pleased to announce the U.S. Food & Drug Administration (FDA) 510(K) clearance of the Spinal Simplicity Liberty-SI Lateral Implant System; a transfixing, lateral sacroiliac (SI) joint fusion system. The Liberty-SI Lateral Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac disruptions and degenerative sacroiliitis.

Key Points: 
  • Spinal Simplicity's Liberty-SI Lateral Implant System is a revolutionary sacroiliac joint fusion technology designed for safer and potentially less invasive treatment of sacroiliac disruptions and degenerative sacroiliitis.
  • OVERLAND PARK, Kan., Dec. 11, 2023 /PRNewswire-PRWeb/ -- Today, Spinal Simplicity is pleased to announce the U.S. Food & Drug Administration (FDA) 510(K) clearance of the Spinal Simplicity Liberty-SI Lateral Implant System ; a transfixing, lateral sacroiliac (SI) joint fusion system.
  • The Liberty-SI Lateral Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac disruptions and degenerative sacroiliitis.
  • The lateral surgical technique first decorticates the bone, preparing the joint for fusion.The Liberty-SI implant is designed to achieve arthrodesis of the SI joint using a lateral technique that passes through the ilium across the sacroiliac joint and into the sacrum, thus transfixing the sacroiliac joint.

VGI Medical, LLC Announces The Launch of the new SiJoin® Transfixing Triangular Trabecular Titanium (T4) Implant System, for Sacroiliac Joint Transfixation, at NASS 2023

Retrieved on: 
Wednesday, October 18, 2023

LARGO, Fla., Oct. 18, 2023 /PRNewswire-PRWeb/ -- VGI Medical, LLC launches the new US FDA 510(k) cleared SiJoin® Transfixing Triangular Trabecular Titanium (T4) Implant System. The transfixing SiJoin® T4 Implant is made from Ti-6AI-4V ELI titanium alloy using an additive manufacturing process, where the porous trabecular construction is engineered to mimic cancellous bone structure. The implant has an engineered lattice design to achieve 500-700 mm pores, and has undergone post processing to create micro and nano surface structures facilitating the proliferation of osteoblast adhesion and bony in-growth. The SiJoin® T4 Implant is engineered with a dual geometric shape designed to be simultaneously positioned within the illium and sacrum, through the respective cortical wall, providing high surface area contact for fixation. The implant is held against rotation via the stabilizer fins positioned between the opposing illium and sacrum surfaces, and the non-circular cross-section of the main body. The patented novel design of the SiJoin® T4 Implant fixes the sacrum and ilium relative to one another, maintaining the anatomical spacing of the SI joint, providing mechanical support by transfixing the SI joint while biologic fusion occurs.

Key Points: 
  • VGI Medical, LLC announces the launch of the new SiJoin® Transfixing Triangular Trabecular Titanium (T4) Implant System.
  • VGI's superior engineering and testing has allowed them to design a titanium alloy implant for use in alleviating sacroiliac joint pain and create a simplified process for the surgeon.
  • LARGO, Fla., Oct. 18, 2023 /PRNewswire-PRWeb/ -- VGI Medical, LLC launches the new US FDA 510(k) cleared SiJoin® Transfixing Triangular Trabecular Titanium (T4) Implant System.
  • The transfixing SiJoin® T4 Implant is made from Ti-6AI-4V ELI titanium alloy using an additive manufacturing process, where the porous trabecular construction is engineered to mimic cancellous bone structure.

SurGenTec® Unveils TiLink™—Revolutionary Posterior Sacroiliac Fusion System Featuring Novel Compression Capability

Retrieved on: 
Tuesday, October 3, 2023

Orthopedic compression technologies have long been utilized in various surgical procedures, such as long bone fixation, spinal stabilization, foot/ankle, etc.

Key Points: 
  • Orthopedic compression technologies have long been utilized in various surgical procedures, such as long bone fixation, spinal stabilization, foot/ankle, etc.
  • Until now, the industry had struggled to achieve effective posterior compression across the sacroiliac joint.
  • SurGenTec’s latest innovation now offers a proven method for providing significant compression across the sacroiliac joint to aid in healing.
  • "We are thrilled to introduce TiLink Posterior Sacroiliac Joint Fusion System," said Travis Greenhalgh, Chief Executive Officer at SurGenTec.

Aurora Spine Announces Full Release of its SiLO TFX™ MIS Sacroiliac Joint Fixation System

Retrieved on: 
Wednesday, September 13, 2023

Carlsbad, Calif., Sept. 13, 2023 (GLOBE NEWSWIRE) -- Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV:ASG) (OTCQB: ASAPF), a designer and manufacturer of innovative medical devices that improve spinal surgery outcomes, announced today that it is in full commercial release of its proprietary SiLO TFX™ MIS Sacroiliac Joint Fixation Device system.

Key Points: 
  • Carlsbad, Calif., Sept. 13, 2023 (GLOBE NEWSWIRE) -- Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV:ASG) (OTCQB: ASAPF), a designer and manufacturer of innovative medical devices that improve spinal surgery outcomes, announced today that it is in full commercial release of its proprietary SiLO TFX™ MIS Sacroiliac Joint Fixation Device system.
  • The patented, minimally invasive SiLO TFX MIS Sacroiliac Joint Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
  • The SiLO TFX MIS Sacroiliac Joint Fixation System includes a Transfixing-Cone, an ilium screw, a sacrum screw and associated instrumentation.
  • I am pleased with the teamwork between Engineering, Operations and Marketing on the full release of the SiLO TFX system."

Aurora Spine to Attend the American Association of Neurological Surgeons Annual Meeting

Retrieved on: 
Wednesday, April 19, 2023

Carlsbad, Calif., April 19, 2023 (GLOBE NEWSWIRE) -- Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV:ASG) (OTCQB: ASAPF), a designer and manufacturer of innovative medical devices that improve spinal surgery outcomes, today announced that it will be attending the 2023 American Association of Neurological Surgeons (AANS) Annual Scientific Meeting.

Key Points: 
  • Carlsbad, Calif., April 19, 2023 (GLOBE NEWSWIRE) -- Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV:ASG) (OTCQB: ASAPF), a designer and manufacturer of innovative medical devices that improve spinal surgery outcomes, today announced that it will be attending the 2023 American Association of Neurological Surgeons (AANS) Annual Scientific Meeting.
  • The meeting will be held at April 21-24, 2023, at the Los Angeles Convention Center – Booth #1011.
  • At this year’s AANS event, Aurora Spine will be highlighting its product line, including DEXA-C™, a cervical cage for anterior cervical discectomy with fusion (ACDF) procedures.
  • The SiLO TFX MIS Sacroiliac Joint Fixation System includes a Transfixing-Cone, an ilium screw, a sacrum screw and associated instrumentation.

VGI Medical, LLC Announces FDA Clearance of the Novel 3D Printed SiJoin® T3 Implant System, for Sacroiliac Joint Transfixation

Retrieved on: 
Tuesday, April 18, 2023

LARGO, Fla., April 18, 2023 /PRNewswire-PRWeb/ -- VGI Medical, LLC announces the new US FDA 510(k) cleared SiJoin®  Triangular Trabecular Titanium (T3) Implant System. The transfixing SiJoin®  T3 Implant is made from Ti-6AI-4V ELI titanium alloy using an additive manufacturing process, where the trabecular construction is engineered to mimic cancellous bone structure. The SiJoin®  T3 Implant is engineered with a dual geometric shape designed to be implanted within the plane of the SI joint, simultaneously positioned within the cortical walls of the ilium and sacrum, providing high surface area contact for transfixation. The implant is held against rotation via the stabilizer fins positioned between the opposing ilium and sacrum surfaces, and the non-circular cross-section of the main body. The novel design of the SiJoin®  T3 Implant fixes the ilium and sacrum relative to one another, maintaining the anatomical spacing of the SI joint, providing mechanical support by transfixing the SI joint while biologic fusion occurs.

Key Points: 
  • VGI Medical, LLC announces it has received 510(k) clearance from the United States Food and Drug Administration to market the transfixing SiJoin® Triangular Trabecular Titanium (T3) Implant System.
  • LARGO, Fla., April 18, 2023 /PRNewswire-PRWeb/ -- VGI Medical, LLC announces the new US FDA 510(k) cleared SiJoin® Triangular Trabecular Titanium (T3) Implant System.
  • Specialized SiJoin® directional instrumentation deploys the implant into the SI joint, positioned across the joint, within the ilium and sacrum for transfixing of the SI joint.
  • We are excited to provide an advancement of this existing technology by incorporating the benefits of a 3D printed titanium implant–.

Aurora Spine Announces Initial Surgeries Conducted Using its SiLO TFX™ MIS Sacroiliac Joint Fixation System

Retrieved on: 
Monday, April 17, 2023

Carlsbad, Calif., April 17, 2023 (GLOBE NEWSWIRE) -- Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV:ASG) (OTCQB: ASAPF), a designer and manufacturer of innovative medical devices that improve spinal surgery outcomes, today announced that initial surgeries using its proprietary SiLO TFX™ MIS Sacroiliac Joint Fixation Device have been performed in recent weeks.

Key Points: 
  • Carlsbad, Calif., April 17, 2023 (GLOBE NEWSWIRE) -- Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV:ASG) (OTCQB: ASAPF), a designer and manufacturer of innovative medical devices that improve spinal surgery outcomes, today announced that initial surgeries using its proprietary SiLO TFX™ MIS Sacroiliac Joint Fixation Device have been performed in recent weeks.
  • The patented, minimally invasive SiLO TFX MIS Sacroiliac Joint Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
  • The SiLO TFX MIS Sacroiliac Joint Fixation System includes a Transfixing-Cone, an ilium screw, a sacrum screw and associated instrumentation.
  • Mr. Trent Northcutt, Aurora’s President, CEO and co-founder, stated, "We are pleased with these initial surgeries using our SiLO TFX, which is a game changing device for the industry.