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This month’s round-up of recent FDA clearances presents a range of technologies used in the surgical treatment of spine disorders, and includes three companies entering the space: Biomendex, McNicoll Surgical and SYNC Surgical.
4WEB Medical | Sacroiliac Joint Truss System (SJTS), K252834
Submitted September 2025, granted January 2026
Primary predicate: SI-BONE iFuse-TORQ Implant System, K222605
FYI: Indicated for fusion of the SI joint for SI joint dysfunction, including SI joint disruption and degenerative sacroiliitis. SJTS is intended for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
The product consists of two initial designs: one, a fully threaded SI fusion device, and a second design incorporating a lag feature. Each configuration will be provided in three diameters with varying lengths to accommodate the patient’s anatomy.
A company spokesman noted that 4WEB expects the SI Joint Truss System to be the company’s fastest-growing product line to date.
Biomendex | AdaptosFuse Bone Graft, K253524
Submitted November 2025, granted February 2026
FYI: The product is indicated for filling bony voids or gaps that are not intrinsic to the stability of the bony structure in the spine area.
Adaptos Fuse is indicated for use in surgically created osseous defects and defects resulting from traumatic injury, including applications in the posterolateral spine, intervertebral disc space, and the pelvic area. The material is designed to resorb over time and be replaced by bone during the natural healing process.
Adaptos Fuse has been engineered to integrate into standard surgical techniques, with handling characteristics intended to support intraoperative efficiency. Its design also supports robust combination with autograft and postoperative imaging visibility.
The platform has previously been utilized in more than 2,700 veterinary orthopedic and dental procedures, providing extensive real-world surgical experience prior to its introduction into human clinical practice.
The clearance is the company’s first, and marks their entry into the U.S. bone graft substitute market. Biomendex, founded in 2018, is based in Tampere, Finland.
Implanet | SWINGO-3D Lumbar Cage System, K254017
Submitted December 2025, granted February 2026
FYI: The Swingo cage range features a portfolio of implant sizes with a design tailored to vertebral anatomy, supporting improved control of interbody fusion.
The titanium implants, manufactured via 3D printing, can be used for all types of procedures, regardless of chosen surgical approach. This clearance includes a dedicated next-generation instrumentation range designed to enhance patient safety while reducing surgical time.
McNicoll Surgical | Falco Fusion System, K253611
Submitted November 2025, granted January 2026
Primary predicate: SIJ Surgical, Outlet Sacroiliac Joint Fusion System, K181881
FYI: Falco is designed for minimally invasive sacroiliac joint fusion in patients with SI joint disruption or degenerative sacroiliitis, and is suitable for ambulatory surgery settings.
Falco comprises titanium alloy screws in 11mm and 13mm diameters, with lengths ranging from 35mm to 75mm. The system comes with disposable Kirschner wires and reusable surgical instruments.
This represents the company’s first FDA 510(k) clearance. McNicoll was founded 2023 and is headquartered in Quebec City, Québec. Leadership brings over 12 combined years of experience in roles at Bodycad.
Medtronic (Medtronic Navigation) | Stealth AXiS Surgical System with Stealth AXiS Spine Clinical Application, K253381
Submitted September 2025, granted February 2026
FYI: The next-generation platform brings planning, navigation, and robotics together into a single intelligent system for spine surgery.
Stealth AXiS is cleared for spine procedures, with an underlying architecture designed to support future cranial and ENT applications (pending 510(k) clearance). Built to support a wide range of surgeon preferences, clinical complexity, and care settings, the platform is designed for use across hospitals and ambulatory surgery centers without reliance on multiple standalone technologies.
A feature of the system is LiveAlign segmental tracking, an capability that allows surgeons to visualize anatomic motion, surgical adjustments, and patient alignment in real time during spine surgery, without the need for repeated imaging.
SYNC Surgical | Cervical Interbody and VBR Fusion System, K252219
Submitted July 2025, granted January 2026
Primary predicate: Summit Spine Channel Cervical Interbody Fusion System, K163494
FYI: When used as a cervical intervertebral body fusion device, the system is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-TI disc.
The system is designed for use with supplemental fixation, and patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral cage.
This represents the company’s first FDA 510(k) clearance. SYNC is located in Plano, Texas, and leadership brings over 25 years of industry experience from roles at ulrich medical USA, 4WEB Medical, Blue Belt Technologies, Stryker, Brainlab and Johnson & Johnson.
