Copy to clipboard 
Spine has been prevalent in launches and regulatory news of late. Let’s look at recent FDA 510(k) clearances that allow these smaller companies to expand their market coverage in the spinal space.
Hardware
Eminent Spine | Sacroiliac Screw System, K240505
Submitted February 2024, granted June 2024
FYI: This system’s 3D-printed titanium and machined titanium material is available in various sizes and configurations to accommodate patient anatomy.
The system includes a tapered nose for ease of insertion, a sharp tip to easily penetrate bone, head and headless screw options and fenestrated and self-harvesting threads.
It is cleared for lateral, superior lateral and S2-AI approaches, and the implants are offered non-sterile.
Spinal Simplicity | Wolff’s Law Anterior Cervical Plate, K240592
Submitted March 2024, cleared May 2024
Primary predicate: Stryker Spine DynaTran Anterior Cervical Plate, K083020
The dynamic titanium alloy system comprises one- to four-level plates in multiple lengths with fixed and variable angle screws. The plates are translatable and employ a nitinol continuous compression element at each level.
They are provided sterile and have an integrated locking mechanism to prevent screw back-out.
Spineart | SCARLET AC-Ti Anterior Cervical Cage, K240699
Submitted March 2024, cleared May 2024
Primary predicate: Spineart SCARLET AC-T Secured Anterior Cervical Cage, K141314
FYI: Building on 10 years of the SCARLET system, the subject device introduces new features such as the MIMETIX. morphometric profile, developed with digital models of the vertebrae to optimize the contact surface between implant and endplates.
The cage allows for fixation with screws and anchors and utilizes Spineart’s proprietary Ti-LIFE additive manufacturing process with a porous structure that closely mimics the trabecular bone structure.
Technology
Avicenna.AI | CINA-VCF AI Detection of Spinal Fractures, K240612
Submitted March 2024, cleared May 2024
Primary predicate: Aidoc BriefCase, K222692
FYI: CINA-VCF is a triage and notification AI tool that detects unsuspected vertebral compression fractures (VCFs) in patients undergoing chest or abdomen CT scans.
The CINA-VCF algorithm identifies and prioritizes vertebral compression fractures and notifies clinicians within seconds.
The tool was validated on 474 CT scans that were performed for clinical indications other than VCF evaluation and acquired on 38 different scanner models from four different manufacturers, achieving excellent sensitivity and specificity results.
By facilitating the early detection of VCFs, CINA-VCF aims to help prevent further bone density loss and additional fractures, and allows fractures to be addressed before they multiply.
Providence Medical Technology | CORUS Navigation Access, K240625
Submitted March 2024, cleared May 2024
Primary predicate: Medtronic Sofamor Danek Navigated Anterolateral Disc Prep Instruments, K211441
FYI: The CORUS Navigation Access System has been cleared for use with the CORUS Spinal System and is also designed for use with Medtronic’s StealthStation for posterior spinal fusion.
The system assists surgeons in locating, accessing and preparing facet joints for posterior fusion.
It supports enhanced accuracy and precision with surgical instruments and spinal implants, and provides improved visualization of facet joints and other anatomical structures during procedures.
