Innovative Spine Implants and Technologies Approved by the FDA in 2024

The FDA’s approval of a spinal implant signifies that the device has undergone a rigorous evaluation to ensure it meets the highest standards of safety, effectiveness, and quality required for use in the United States. This process involves comprehensive preclinical and clinical testing to demonstrate the device’s ability to achieve its intended purpose, such as relieving pain or improving spinal function, without posing undue risks to patients. Manufacturers must comply with strict regulatory requirements, including meticulous design, manufacturing, and quality control protocols. Depending on the device’s complexity, it may follow a streamlined equivalence pathway (Class II) or undergo a more intensive review involving clinical trials (Class III). FDA approval not only provides legal authorization to market the device in the U.S. but also instills confidence among healthcare professionals and patients while serving as a global benchmark for medical device standards.

In 2024, the main implants approved by the FDA include a majority of cages (38%), technology-driven devices (24%), and facet joint devices (10%). It is clear that companies are consolidating their portfolios with 3D-printed, expandable, and stand-alone cages while focusing their investments on imaging, robotics, and advanced technology.

Please find enclosed the main FDA aprovals in 2024:

1. SpineGuard obtains FDA clearance for commercial release of its “PsiFGuard” new smart drilling device dedicated to sacroiliac joint fusion
2. Eminent Spine Scoliosis Deformity Pedicle Screw System Received FDA 510(k) Clearance on August 20, 2024
3. Eminent Spine’s SI Screw System Received FDA 510(k) Clearance on June 4, 2024
4. Atlas Spine Announces FDA Clearance of its HiJAK Expandable Lateral Lumbar Interbody System
5. Carlsmed Announces FDA Clearance for aprevo® Cervical Breakthrough Fusion Device
6. Astura Medical Receives FDA Clearance for the EGPS System: Expanding Robotic Integration in Spinal Surgery
7. Fiagon GmbH Receives FDA Clearance for Spine Platform and Showcases Innovative Solutions at NASS and EUROSPINE 2024
8. Vy Spine Receives FDA Clearance for New OsteoFab® Lumbar Cage
9. Vy Spine Announces FDA Clearance of 3D Printed LumiVy OsteoVy PEKK Lumbar IBF
10. Foundation Surgical Secures 510(k) Clearance for Innovative Lateral Interbody System
11. SIGNUS Receives FDA Approval for TETRIS® ST & TETRIS® R ST PLIF Cages
12. Life Spine Announces FDA 510(k) Clearance for the ARx® SAI Spinal Fixation System
13. Camber Spine Receives FDA Clearance for SPIRA-A Integrated Fixation System
14. eCential Robotics Receives FDA 510(k) Clearance for Spine Navigation and Robotic-Assistance Device
15. Providence Medical Technology, Inc. Announces FDA Clearance of CORUS™ Navigation Access System for Use with Medtronic’s StealthStation™ Surgical Navigation in Posterior Spinal Fusion
16. Spinal Simplicity Announces FDA Clearance of Its Wolff’s Law Anterior Cervical Plate System
17. VUZE Medical Announces U.S. FDA 510(K) Clearance for Second-Generation Software-Based 3D Guidance System for Spine Surgery.
18. Spineart Receives 510(k) Clearance for SCARLET® AC-Ti Anterior Cervical Cage
19. SC MEDICA Announces Landmark FDA Clearance For Its FFX® Facet Cage For Lumbar Spinal Fusion.
20. ZygoFix Receives FDA Clearance for its zLOCK Lumbar Facet Fixation System
21. OrthoPediatrics Corp. Receives “Breakthrough Device” Designation from FDA for eLLi™ Growing Rod System for Pediatric Patients with Scoliosis
22. Innosys MT receives FDA Approval for UniSpace® Stand-Alone C Cage
23. Xstim, Inc. Receives FDA Approval for Xstim™ Spine Fusion Stimulator
24. Astura Medical Receives FDA 510(k) Clearance For The Dominion Expandable Corpectomy System
25. SurGenTec® Receives FDA Clearance for OsteoFlo® HydroPutty™, a Hydrophilic Synthetic Bone Graft
26. Nevro Receives FDA 510(k) Clearance to Use SI Fixation System Without Need to Include Lateral Screw
27. SI-BONE, Inc. Receives FDA 510(k) Clearance for a Smaller Diameter iFuse Bedrock Granite Implant with an Expanded Indication and Application
28. Inspire® 3D Printed Trabecular PEEK™ With HAFUSE® Lumbar Interbody System Cleared by FDA
29. Providence Medical Technology Announces FDA Clearance of CAVUX® FFS-LX Lumbar Facet Fixation System for 1- and 2-Level Lumbar Spinal Fusion
30. MiRus Receives Breakthrough Device Designation for Spine Implant

We have made an effort to include all spine products that received FDA approval in 2024. Please accept our apologies if any have been missed; this does not mean they are not important to us but simply that they were overlooked. Thank you very much for your understanding.