From softwares to implants, here are 10 spine products earning FDA nods since May 15.
1. Accelus’ FlareHawk interbody fusion device was FDA-cleared for use in MRI scanning under certain conditions. The FDA’s 510(k) clearance was based on safety testing that found FlareHawk implants met established ASTM standards for MRI compatibility.
2. Expanding Innovations earned FDA clearance for its N-Gage lumbar plate system.
3. Cerapedics’ PearlMatrix P-15 peptide enhanced bone graft for lumbar spinal fusion earned FDA premarket approval. The FDA granted it a Class III drug-device combination product for single-level transforaminal lumbar interbody fusion in adults for degenerative disc disease.
4. Curiteva’s Inspire Trabecular PEEK standalone anterior lumbar interbody fusion system earned FDA 510(k) clearance.
5. Dymicron’s Triadyme-C artificial disc earned the FDA’s investigational device exemption approval. The IDE approval opens the door for a U.S. trial of the disc, which is designed for patients with degenerative disc disease.
6. Wenzel Spine received FDA clearance for panaSIa, an expandable sacroiliac fusion implant. The clearance marks the first FDA clearance of an expandable SI fusion implant.
7. The FDA cleared Rivanna’s SpineNav-AI image processing software and Accuro 3S diagnostic ultrasound system.
8. Spectrum Spine earned FDA 510(k) clearance for its family of lumbar cage implants.
9. SurGenTec earned additional FDA clearance for its OsteoFlo HydroFiber. The new 510(k) clearance adds indications for use as a bone void filler for the treatment of tumors, cysts, trauma, and osteomyelitis.
