BOCA RATON, Fla.--(BUSINESS WIRE)--May 29, 2026--
SurGenTec, LLC, a leader in innovative spine and orthopedic technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k)
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SurGenTec, LLC, a leader in innovative spine and orthopedic technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its ION-C™ navigation instruments for use with the ION-C™ posterior cervical facet fixation implant. The system is engineered for compatibility with Medtronic’s StealthStation™ navigation platform, enabling enhanced precision during posterior cervical fusion procedures.
Designed to support enhanced procedural accuracy and engineered for compatibility with navigation, the ION-C™ navigation instruments are intended to assist surgeons in precisely locating anatomical structures — specifically the cervical facet joint — during open or minimally invasive spinal procedures to support implant placement and surgical workflow efficiency.
ION-C™ was engineered with a zero-profile implant design and controlled drill-to-implant geometry to support controlled, non-impact placement and implant depth accuracy. The system was developed to help maintain the facet joint in a neutral position while reducing the risk of unintended joint expansion during insertion, supporting controlled posterior cervical fixation while helping preserve native cervical alignment.
Key potential benefits of navigated ION-C™ facet fixation include:
As navigation-assisted spine procedures continue to evolve, the ION-C™ navigation instruments represent another step forward in precision-driven cervical spine technology.
Dr. Micah Smith, an orthopedic spine surgeon at Parkview Health in Fort Wayne, Indiana, stated:
“This is an exciting time in spine surgery as enabling technologies continue to support minimally invasive techniques and help reduce intraoperative radiation exposure. Navigation-assisted placement of ION-C may help surgeons improve visualization and workflow, particularly in anatomically challenging cases such as severely arthritic facet joints or levels where fluoroscopic imaging may be limited by patient anatomy. These capabilities are intended to support procedural accuracy and surgical efficiency.”
About SurGenTec, LLC
SurGenTec is a privately held medical device company dedicated to advancing spine and orthopedic surgery through innovative, minimally invasive technologies. Focused on improving clinical outcomes and addressing unmet needs in posterior cervical fixation, the company offers a comprehensive portfolio that includes the ION-C™ Facet Fixation System featuring a zero-profile implant design and controlled drill-to-implant geometry, advanced bone graft solutions, and a range of precision-engineered implants and instruments designed to enhance surgical efficiency and performance. The navigation platform rollout will commence immediately.
SurGenTec Announces FDA Clearance of ION-C™ Navigation for Real-Time Guidance in Posterior Cervical Facet Procedures
A bus struck six vehicles on Interstate 95 in Virginia early Friday as traffic slowed for a work zone, killing five people and injuring 34, including the driver, authorities said.
The crash happened at about 2:35 a.m. on southbound I-95 in Stafford County, near Quantico, Virginia. All five of the people who died were in vehicles hit by the bus, and three of the injured were in critical condition, police said.
“The preliminary investigation indicates that traffic was slowing southbound for an upcoming work zone,” state police said in a news release. “A bus failed to slow for traffic and struck six vehicles."
It was not immediately known what the bus was being used for or how many people were aboard.
“We’ve got patients in multiple hospitals. We’ve got the driver at a hospital here,” said Peyton Vogel, a Federal Transit Administration spokesperson who was on the scene. “I’ve got to say, this is one of the most tragic things I’ve ever seen. Absolutely tragic.”
Mary Washington Healthcare said it received 19 patients from the crash. It posted online that seven of the patients were taken to its trauma center in Fredericksburg, where four were being discharged and three remained in treatment — one in serious condition and two in critical condition. Twelve were taken to its hospital in Stafford, where they were later discharged in good condition.
The crash is under investigation and charges are pending, police said. The National Transportation Safety Board posted online Friday that it was sending a “go-team” to conduct a safety investigation into the crash and that it would have a spokesperson at the scene.
The southbound lanes had reopened by noon Friday, but traffic was still backed up for a couple of miles, according to a state transportation advisory.
Two of the surviving passengers, bruised and shaken, described what it was like inside the bus in an interview with the Richmond Times-Dispatch outside the hospital where they had been examined.
Rhonda Wright and Wayne Tobin said they sensed something was wrong well before the crash, describing the driver as reckless and the bus as traveling at extremely high speeds before it slammed into the slowing traffic.
The initial collision was only the start of their terror, they said — the bus kept moving, striking one vehicle after another as passengers screamed, smoke filled the interior and belongings flew through the air.
“The bus was still going, still hitting cars,” Wright said. “We felt like we were in a death trap because there was no way to stop the bus.”
When the bus finally stopped, people scrambled to escape through the windows. Tobin said he emerged covered in blood from other passengers. Wright said one man’s teeth had been knocked out.
“I’m 64 years old, and I thought I was going to die,” Wright said. “I’m just glad I’m alive today.”
Tobin was headed to Raleigh for his mother’s funeral. Wright was traveling farther to Greensboro to visit family. Both were missing their phones and identification in the wreckage of the bus.
“My wallet is in there, my ID is in there, my phone is in there,” Wright said. “You can’t do anything without your ID.”
The bus was operated by E&P Travel, Inc., based in Kings Mountain, N.C. A compliance snapshot from the Federal Motor Carrier Safety Administration showed only one injury accident involving the company’s vehicles in the previous two years, and listed its compliance rating as “satisfactory.”
The company was incorporated Nov. 24, 2023, by Shuo Liu, according to records from the North Carolina Secretary of State’s office. Liu is also listed as the registered agent. The FMCSA site said the company operated four vehicles and had 11 drivers.
While it is too soon to say what caused Friday's crash, federal authorities have been grappling with interstate passenger bus safety issues for decades.
Following a series of passenger bus crashes in 2008 that killed 41 people, the U.S. Department of Transportation published a Motorcoach Safety Action Plan.
The NTSB investigated 16 fatal motorcoach crashes between June 1998 and January 2008, finding that driver-related problems such as fatigue, medical condition, and inattention accounted for 56 percent of the accidents. The agency said driver-related problems were responsible for 60 percent of the fatalities in those crashes.
Among the actions recommended were creation of a pre-employment driver history screening program, and a national drug- and alcohol-testing database “to enable motorcoach operators to determine if drivers have a history of violating DOT alcohol or drug rules.”
Associated Press contributors include Holly Ramer in Concord, N.H. Breed reported from Wake Forest, N.C. and Verduzco from Kings Mountain, N.C.
This photo, provided by the Virginia State Police, shows the scene of a fatal accident involving a passenger bus on Interstate 95 in near Quantico, Va., on Friday, May 29, 2026. (Virginia State Police via AP)
This photo, provided by the Virginia State Police, shows the scene of a fatal accident involving a passenger bus on Interstate 95 in near Quantico, Va., on Friday, May 29, 2026. (Virginia State Police via AP)
This photo, provided by the Virginia State Police, shows the scene of a fatal accident involving a passenger bus on Interstate 95 in near Quantico, Va., on Friday, May 29, 2026. (Virginia State Police via AP)
