From navigation systems to hardware, here are nine spine technologies earning FDA certifications and clearances since Jan. 19.
1. Cresco Spine earned FDA 510(k) clearance for its spring distraction system. The SDS implant is designed for addressing early onset scoliosis, and it previously earned the FDA’s Breakthrough Device Designation.
2. SurGenTec earned FDA 510(k) clearance of its ION-C facet fixation system. ION-C is designed for posterior cervical fusion, and the clearance includes indications for the treatment of cervical pseudoarthrosis when implanted bilaterally within the facet joints.
3. Spine Innovation’s Logic titanium implant system earned FDA 510(k) clearance. The device is the next generation of the company’s implant system which has been used in the U.S. for 10 years. Logic’s patented design has a reduced profile and more than doubles in size during expansion.
4. Medtronic earned the FDA’s 510(k) clearance for its Stealth AXiS system that brings planning, navigation and robotics into one spine platform. Stealth AXiS is cleared for use in spine surgery, and it is expected to support cranial and ENT pending additional clearance.
5. Medtronic’s Infuse bone graft earned the FDA’s premarket approval for one- and two-level transforaminal lumbar interbody spinal fusions. The expanded approval allows use with PEEK and titanium interbody cages. Infuse is now the only PMA-approved growth factor bone graft for ALIF, OLIF and TLIF.
6. The FDA granted Empirical Spine’s LimiFlex dynamic saggittal tether premarket approval. LimiFlex is a motion-preserving system for lumbar spinal stenosis associated with Grade I degenerative spondylolisthesis after decompression.
7. The FDA granted 510(k) clearance to 4Web Medical’s SI joint truss system. The system is indicated for sacroiliac joint fusion to address sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis. It comes in two initial designs — one fully threaded and one with a lag feature.
8. Synergy Spine Solutions earned the FDA’s premarket approval for its Synergy Disc. The device is approved for 1-level cervical disc replacement at C3 to C7 for patients with degenerative disc disease. Approval is supported by findings from an Investigational Device Exemption.
9. Implanet’s Swingo anterior cervical cage earned the FDA’s 510(k) clearance. The Swingo cage range includes multiple implant sizes and is made with 3D printing technology. It can be used for all types of spine procedures.
