PRESS RELEASES

The objective of the study was to evaluate the in vivo performance of SurGenTec OsteoFlo HydroFiberTM (OF-HF) (test material), compared to autograft (ICBG) in an established posterolateral spine fusion rabbit model. The test material was evaluated as a stand-alone and extender product with autograft (1:1).

BOCA RATON, Fla.–(BUSINESS WIRE)–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 TiLink^™ Navigation Instruments for use with the TiLink^™ SI Joint Fusion System in sacroiliac joint procedures. The system is engineered for compatibility with Medtronic’s StealthStation^™ navigation platform, enabling enhanced precision during minimally invasive SI joint fusion surgeries.

BOCA RATON, Fla.–(BUSINESS WIRE)– SurGenTec^®, a medical device innovation company focused on advancing treatment options for orthopedic and spine surgery, today announced FDA clearance of its ION-C™ Facet Fixation System. ION-C™, part of SurGenTec^®’s posterior cervical platform, has received expanded indications allowing for the treatment of cervical pseudoarthrosis when implanted bilaterally within the facet joints. This clearance is supported by compelling long-term clinical evidence from an Institutional Review Board (IRB)–approved study evaluating long-term surgical outcomes.

BOCA RATON, Fla.–(BUSINESS WIRE)–SurGenTec^® has received additional FDA 510(k) clearance for OsteoFlo^® HydroFiber^™, its advanced synthetic bone graft, marking another key regulatory milestone. This expansion of indications now includes use as a bone void filler for the treatment of tumors, cysts, trauma, and osteomyelitis. This landmark clearance represents a significant advancement in the capabilities of SurGenTec^®’s cutting-edge technology and highlights the company’s commitment to enhancing patient care in orthopedic and spine surgery.

BOCA RATON, Fla.–(BUSINESS WIRE)–SurGenTec^®, a leading innovator in minimally invasive orthopedic and spine surgery solutions, is proud to announce the launch of its new TiLINK^®-INSITE^™ Sacroiliac Joint Fusion System. The system—now available in a sterile, surgery-ready kit—has already been successfully utilized in initial procedures performed across multiple U.S. sites, receiving strong endorsements from physicians.

BOCA RATON, Fla.–(BUSINESS WIRE)–SurGenTec, a pioneering medical device company specializing in orthopedic and spine technologies, proudly announces the first implantations and 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its revolutionary OsteoFlo HydroPutty Synthetic Bone Graft.

BOCA RATON, Fla.–(BUSINESS WIRE)–SurGenTec, a privately held medical device company focusing on spine and orthopedic technologies, proudly announces FDA clearance for TILINK-P, a first-of-its-kind, minimally-invasive implant that offers hope for individuals suffering from chronic sacroiliac (SI) joint pain.

BOCA RATON, Fla.–(BUSINESS WIRE)–A leader in innovative medical devices, is proud to announce clearance from the U.S. Food and Drug Administration for their proprietary TILINK-L Sacroiliac Joint Fusion System. The SI joint implant may be implanted from a lateral or posterior/oblique approach and uses unique surface technology to optimize bone growth. This implant will be SurGenTec’s inaugural “First Implant in the Sacroiliac Family of Products.

BOCA RATON, Fla.–(BUSINESS WIRE)–SurGenTec^®, a privately held spine and orthopedic technology company based in Boca Raton, FL, announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for ION^™ Screw, its proprietary stand-alone spine fixation implant.

Minimally invasive (MIS) lumbar fusion has become a popular alternative to traditional methods of lumbar decompression and fusion. When compared with the open technique, the minimally invasive approach can result in decreased pain and blood loss as well as a shorter length of hospitalization. However, the narrower working channel in the MIS technique increases the difficulty of decortication and bone grafting.

This paper describes a novel set of instruments, the 3D GraftRasp System by SurGenTec, that physicians can use to help create an optimal environment to fuse the facet joints and lateral gutters during minimally invasive lumbar fusions. Retrospective clinical data from case reports are presented on 3 patients that underwent single level and multi-level MIS lumbar fusions utilizing the 3D GraftRasp System. The case reports show that the 3D GraftRasp System can provide a viable solution for physicians wanting to perform a minimally invasive procedure to achieve fusion while decorticating and packing bone graft around the facet joints and lateral gutters.

The 3D GraftRasp System is the only device to receive FDA clearance that allows for both decortication of bone and the delivery of autograft, allograft or synthetic bone graft. It is approved for general orthopedic use and spine procedures. “In spine procedures, the transverse processes and facet joints may now be targeted in a more efficient and effective surgical technique pioneered by SurGenTec,” says Founder and CEO Travis Greenhalgh. The 3D GraftRasp System is ideal for use in posterolateral or intertransverse lumbar fusion cases.

BOCA RATON, Fla.–(BUSINESS WIRE)–SurGenTec, a privately held spine and orthopedic technology company, announced today it has received FDA clearance for a neurostimulation indication for their ALARA Neuro Access Needle Kit. The ALARA system is used for targeting and assisting in cannulating a pedicle. Targeting needles are generally the first instrument used to perforate the pedicle wall before advancing a guidewire, tap or pedicle screw.

BOCA RATON, Fla.–(BUSINESS WIRE)–SurGenTec^® announced today the successful completion of the initial clinical launch of its new GraftGun bone graft delivery system combined with ViBone Viable Bone Matrix prefilled tubes. This early evaluation of the combined products was focused in the Minimally Invasive Spine (MIS) surgery field.

The ten companies with the BEST new spine care technologies for 2018 are: Augmedics, DiFusion Inc., Green Sun Medical, K2M, Inc., MiRus, LLC, Power T Handle, LLC, RTI Surgical, Inc., Simplify Medical, Inc., SurGenTec and Tyber Medical LLC.

SurGenTec^® LLC, a South Florida based medical device company has been awarded the 2018 Orthopedics This Week Spine Technology Award and will be formally receiving their award during the 2018 North American Spine Society meeting. This year’s meeting will be held Sept. 26th -28th in Los Angeles, CA. The awarded technology from Surgentec’s product line is the unique and innovative ALARA^™ access needle.