MedPath

SpineGuard's PsiFGuard Receives FDA Clearance for Sacroiliac Joint Fusion

• SpineGuard's PsiFGuard, a smart drilling device for posterior sacroiliac fusion (PsiF), has received FDA 510(k) clearance for commercial use in the United States. • The PsiFGuard device utilizes SpineGuard's Dynamic Surgical Guidance (DSG®) technology to enhance the accuracy of implant placement in SI joint fusion procedures. • Developed in partnership with Omnia Medical, PsiFGuard aims to address the challenges of locating the SI joint, which is critical for successful fusion outcomes. • The sacroiliac joint fusion market is projected to grow significantly, driven by the increasing prevalence of degenerative sacroiliac joint pain and new payment codes.

SpineGuard, in collaboration with Omnia Medical, has announced FDA 510(k) clearance for its PsiFGuard device, a new smart drilling system designed to improve the precision of posterior sacroiliac fusion (PsiF) procedures. This clearance marks a significant milestone for SpineGuard's expansion in the United States and the deployment of its Dynamic Surgical Guidance (DSG®) technology.
The PsiFGuard device leverages SpineGuard's proprietary DSG® technology, which uses real-time local conductivity sensing to guide the placement of bone implants. The device is specifically designed to address the challenges associated with accurately locating the sacroiliac (SI) joint during fusion surgery, a critical factor for successful outcomes.

Clinical Significance

Sacroiliac joint dysfunction is estimated to affect more than 15% of patients with chronic lower back pain, leading to debilitating pain and reduced quality of life. The global sacroiliac joint fusion market is substantial, reaching over $539 million in 2021 and projected to grow at a CAGR of 19% from 2022 to 2030, according to Grandview Research. The introduction of a new payment code in the United States in January 2024 for posterior sacroiliac joint fusion surgery is expected to further accelerate market growth.

Expert Commentary

Stéphane Bette, Deputy CEO and Co-Founder of SpineGuard, stated, "We are very pleased by this new clearance that will help us accelerate our growth as we continue to deliver consistently on our new product road map. The efficacy of our PsiFGuard device in locating the SI joint was clearly demonstrated in the submitted pre-clinical testing which allowed for a smooth clearance process."
Troy Schifano, CEO and Co-Founder of Omnia Medical, added, "We’ve seen that proper placement of the implant is essential to a successful SI Joint fusion. Locating the joint is critical for this to occur but can be very challenging. However, the data SpineGuard provided to the FDA during the clearance process has confirmed PsiFGuard drastically enhances the accuracy of the placement of the wire guiding the implant."

Technology and Future Directions

SpineGuard's DSG® technology has been utilized in over 100,000 surgical procedures worldwide, with 34 peer-reviewed studies demonstrating its benefits for patients, surgeons, and hospitals. The company is focused on expanding the application of its DSG® technology to other areas, including scoliosis treatment, dental implantology, and surgical robotics. SpineGuard also plans to accelerate sales growth in the United States, roll out PsiFGuard and other new products, and register its full product line in China during the second half of 2024.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

icotec's BlackArmor Implants Receive FDA Clearance for Spinal Infection Treatment

icotec's BlackArmor implants have received FDA 510(k) clearance for stabilizing the spine in de novo spinal infections, marking a significant advancement in treatment.
The FDA granted Breakthrough Device Designation to icotec's BlackArmor portfolio, acknowledging the technology's potential benefits for patients with spinal infections.

Spinogenix's SPG601 Shows Promise in Phase 2 Trial for Fragile X Syndrome

Spinogenix's SPG601 demonstrated a significant reduction in high-frequency gamma band activity, an EEG abnormality associated with Fragile X syndrome (FXS).
The Phase 2 trial met its primary endpoint, suggesting SPG601's potential to improve brain activity related to learning and memory in FXS patients.

FDA Clears Foundation Surgical's Vertiwedge® Intraosseous System for Vertebral Body Replacement

The FDA has granted 510(k) clearance to Foundation Surgical's Vertiwedge® Intraosseous System, a novel device for partial vertebral body replacement in the thoracolumbar spine.
Indicated for use in T1-L5, the device addresses conditions like trauma, fractures, tumors, and degenerative spine disease by restoring vertebral height.

L&K Biomed's BluEX Lumbar Expandable Cage System Receives FDA Approval

L&K Biomed secured FDA 510(k) clearance for its BluEX Lumbar Expandable Cage System, designed for enhanced bone integration and versatile surgical approaches.
The BluEX system features six cage designs adaptable for anterior, posterior, lateral, ATP, and endoscopic lumbar approaches, offering surgeons greater flexibility.

FDA Approves Abionic's CAPSULE PSP for Early Sepsis Detection

Abionic's CAPSULE PSP, an innovative in vitro diagnostic test for early sepsis detection, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
The CAPSULE PSP test measures Pancreatic Stone Protein (PSP) levels, an emerging biomarker that can detect sepsis 24-48 hours earlier than current standard methods.

Paragonix Technologies' KidneyVault Receives FDA Clearance for Portable Kidney Perfusion

Paragonix Technologies has received FDA 510(k) clearance for its KidneyVault System, a portable hypothermic perfusion device for donor kidney preservation.
The KidneyVault integrates digital monitoring with perfusion technology, aiming to improve kidney preservation during transport and expand the donor pool.

Grifols' Fibrin Sealant Gains FDA Approval for Pediatric Surgical Bleeding

Grifols' fibrin sealant (FS) has been approved by the FDA for use in pediatric patients undergoing surgery to control bleeding, expanding its availability in the U.S.
The approval is based on a Phase 3b study demonstrating the safety and efficacy of Grifols FS in achieving hemostasis within four minutes in pediatric surgical patients.

Catalyst OrthoScience's Shoulder Fracture System Receives FDA Clearance

Catalyst OrthoScience received FDA 510(k) clearance for its Catalyst Fracture Shoulder System, designed for reverse shoulder arthroplasty in proximal humeral fractures.
The system addresses challenges in tuberosity fixation and healing, a critical aspect of treating proximal humeral fractures with reverse shoulder arthroplasty.

FDA Expands Indications for Cerapedics' i-FACTOR Bone Graft in Cervical Spinal Fusion

The FDA has approved expanded indications for Cerapedics' i-FACTOR P-15 Peptide Enhanced Bone Graft, enhancing its utility in spinal fusion procedures.
i-FACTOR is now approved for single-level ACDF with an allograft bone ring or with PEEK or titanium interbody devices, alongside anterior plate fixation.

SI-BONE's iFuse TORQ TNT Implant System Receives FDA Clearance for Pelvic Fragility Fractures

SI-BONE's iFuse TORQ TNT implant system has received FDA 510(k) clearance, offering a novel solution for pelvic fragility fractures.
The TNT system is designed to address the specific anatomical and bone mineral density needs of the sacrum and ilium, potentially improving treatment outcomes.

Reference News

[1]
SpineGuard Obtains FDA Clearance for Commercial Release of Its “PsiFGuard” New Smart ...
orthospinenews.com · Oct 2, 2024

SpineGuard's PsiFGuard device, designed for secure Posterior sacroiliac Fusion (PsiF) surgery, received FDA 510K authori...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy