From implants to robots, the FDA has granted new approvals and expanded indications to a swath of spine and orthopedic technologies since Sept. 4.
Eight notes:
1. Nevro earned FDA approval and began a limited market release of its HFX iQ spinal cord stimulator with HFX AdaptivAI.
2. Cerapedics earned FDA approval to expand the use of its spinal fusion biologic, i-Factor P-15.
3. Think Surgical's TMini robot was FDA cleared for use with Zimmer Biomet's Persona knee replacement system.
4. 3D Systems has earned FDA clearance for its Total Ankle Patient-Matched Guides, which can be used with Smith+Nephew’s Salto Tarlaris total ankle prosthesis and Cadence total ankle system.
5. 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.
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. SpineGuard earned the FDA's clearance to release the PsiFGuard, a smart drilling device for sacroiliac joint fusion.
8. Medical device company OrthAlign has earned FDA clearance for its Lantern Hip handheld technology for direct anterior total hip arthroplasty.