Here are 30 notable spine devices that have earned clearance from the FDA since the beginning of 2024:
Note: This is not an exhaustive list of all systems earning clearance in 2024.
1. Carlsmed earned FDA clearance for aprevo cervical anterior cervical discectomy and fusion interbody system. Carlsmed's aprevo technology previously earned FDA Breakthrough Device designation. Aprevo spinal fusion implants are designed with artificial intelligence-based surgical planning software and digital production.
2. Frank Phillips, MD, performed the first spine case with Augmedics' new CT-to-fluoroscopy registration method. Augmedics earned FDA 510(k) clearance for the method, which allows surgeons to navigate cases with preoperative CT scan and fluoroscopic images. The images are from a standard 2D C-arm, and the technology eliminates the need for 3D intraoperative imaging.
3. Remedy Logic, a radiology AI company, received FDA clearance for RAI, an AI-powered program for spine MRI interpretation. RAI was initially introduced in 2020 and helped radiologists improve efficiency and increased safety for patients.
4. Foundation Surgical earned FDA 510(k) clearance for its Vertiwedge intraosseous device. Vertiwedge is a motion-sparing partial vertebral body replacement device that pairs with the newly launched Vertebral Body Osteotomy procedure. It is the first device of its kind designed to facilitate and maintain vertebral body correction of partially collapsed vertebrae.
5. VySpine earned FDA clearance for its LumiVy OsteoVy PEKK lumbar interbody fusion device. The device was cleared for use in intervertebral body fusion at one or two contiguous levels to treat degenerative disc disease.
6. Avicenna.AI, a medical imaging AI company, has earned FDA clearance for its CINA-CSpine tool, designed to support the detection of cervical spine fractures from CT images.
7. Eminent Spine's scoliosis deformity pedicle screw system, which consists of rods, polyaxial screws with set caps and cross connectors with locking screws, has earned FDA clearance.
8. DePuy Synthes, Johnson & Johnson's orthopedic company, earned FDA 510(k) clearance for and launched Velys Spine. Velys Spine is a dual-use robotics and standalone navigation platform created in collaboration with eCential Robotics.
9. Medical device manufacturer Life Spine has earned clearance from the FDA to market its ARx SAI spinal fixation system. The fixation system can be utilized through a sacral alar Iliac trajectory in S1 and/or S2, providing maximum fixation across the sacroiliac joint.
10. Camber Spine earned FDA 510(k) approval for its Spira-A integrated fixation system. The device is designed for anterior lumbar interbody fusion and allows packing with bone graft material.
11. Stryker's Q Guidance System with Spine Guidance 5 Software featuring Copilot has earned 510(k) clearance from the FDA. The software is intended to provide multiple feedback modalities for supporting bone resection, pedicle preparation and screw delivery to help maximize a surgeon's effectiveness and enhance patient outcomes.
12. ECential Robotics earned FDA 510(k) clearance for a device to help plan and instrument spinal fusions.
13. Providence Medical Technology earned FDA clearance for its Corus posterior cervical stabilization to treat up to three-level cervical degenerative disc disease. Clearance was based on an investigational device exemption study across 18 U.S. sites.
14. Pierce Nunley, MD, performed the first U.S. case with Sail Fusion's BowTie sacroiliac joint fusion system. The system earned FDA clearance in April and is the first SI fusion technology based on validated joint fusion principles set by the AO Foundation.
15. Eminent Spine's SI screw system earned FDA's 510(k) clearance.
16. Spinal Simplicity earned FDA 510(k) clearance for its Wolff's Law anterior cervical plate system. The device provides continuous compression, which may help in the development of spinal fusion.
17. Canary Medical earned the FDA's breakthrough designation for its smart lumbar spine cartridge. The Canturio Lumbar Cartridge is designed for lumbar spinal fusion from L1-S1 and provides kinematic data after surgery.
18. Vuze Medical's software-based 3D spine guidance earned FDA 510(k) clearance for its second iteration. Vuze 2.0 supports a broader range of surgical C-arms and accommodates more sources of 3D image data from preoperative and in-OR imaging.
19. Spineart received FDA 510(k) clearance for its SCARLET AC-Ti secured anterior cervical cage. The SCARLET AC-Ti uses Spineart's proprietary Ti-LIFE technology, an additive manufacturing process that has a porous structure that mimics the trabecular bone structure.
20. Orthopedic technology company Implanet has earned FDA clearance for its hybrid fixation system, the Jazz Spinal System. The spinal system is the result of a 2022 collaboration between Implanet and Sanyou Medical. It features a comprehensive solution of pedicle screws.
21. A smaller version of SI-Bone's iFuse bedrock granite implant system was launched, and the first cases with it were completed.
22. ZygoFix earned FDA clearance for its zLock device. ZLock is a lumbar facet fixation system that uses the spine's bone structure to lock connecting joints instead of relying on screws.
23. Spinal Simpicity's Patriot-SI posterior implant system for sacroiliac joint fusion earned FDA 510(k) clearance. The implant is designed to work in combination with the company's Liberty-SI lateral system.
24. Spine medtech company 4Web Medical earned regulatory clearance to market its anterior spine truss system with anchor fixation.
25. AIL Fusion earned FDA clearance for its BowTie sacroiliac joint fusion system. The minimally invasive system is the first SI fusion technology based on validated joint fusion principles set by the AO Foundation.
26. Nevro earned FDA 510(k) clearance to use its sacroiliac joint fixation system without having to include a lateral screw. Nevro1 has been proven to immediately transfix the sacroiliac joint for long-term fusion.
27. Momentum Health earned FDA 510(k) clearance for Momentum Spine, an artificial intelligence-powered app for spine care. The app is designed to help patients quantify postural asymmetries, including scoliosis.
28. SI-Bone earned FDA 510(k) clearance of the iFuse Bedrock Granite implant system in a smaller diameter. The clearance also applies to an expanded indication in pediatric patients and use in the S1 trajectory.
29. Curiteva's Inspired 3D-printed lumbar interbody fusion system earned FDA 510(k) clearance. The Inspire lumbar interbody fusion system can be used in anterior, transforaminal, posterior and lateral approaches.
30. Providence Medical Technology earned FDA clearance for its Cavux FFS-LX lumbar facet fixation system. It is an integrated cage and screw system that's implanted bilaterally in the facet joints for patients with degenerative disc disease.