First 510(k) Clearance Recap and Surgical Enabling Technologies of Note

This recap covers two companies that achieved first U.S. clearances in recent months, and two by established companies in the spine segment.

Recent Enabling Technology Clearances of Note in Spine

Globus Medical | Excelsius3D, K210912

• Submitted March 2021, granted August 2021
• Intelligent intraoperative 3-in-1 imaging system
• Consolidates 360° cone-beam CT, fluoroscopy and high-resolution digital radiography into one solution, eliminating the need for multiple imaging systems during one procedure
• Functions as a standalone imaging unit, or as an extension to the present Excelsius ecosystem; provides a mobile X-ray system designed for 2D fluoroscopy, 2D digital radiography and 3D imaging of adult and pediatric patients
• Globus is ramping up production and preparing for commercial release in 4Q21

NuVasive Pulse System

NuVasive | Pulse Platform, K210574

• Submitted February 2021, granted July 2021
• Integrated technology platform designed to increase safety, efficiency and procedural reproducibility of spine surgery
• Allows surgeons to easily access multiple technologies from a condensed footprint and address common surgical challenges; currently the only enabling technology platform with the ability for utilization in 100% of spine procedures
• Includes NuVasive’s elements of radiation reduction/imaging enhancement, navigation, global alignment for surgical planning/intraoperative assessment, patient-specific rod bending and wireless connectivity and control of Pulse from all members of the O.R. team
• Clearance follows approval under the CE Mark, received earlier this year

Companies Receiving First FDA 510(k) Clearances Within 2021

Spine

Acuity Surgical Devices | A-Link Z Spinal Cages, K201671

• Submitted June 2020, granted May 2021
• Primary predicate: OsteoVasive A-Link Z, K133827
• Indicated for intervertebral body fusion in skeletally mature patients who have had at least six months of non-operative treatment
  About the company:
  • Established 2013, headquartered in Dallas, Texas, United States
  • Portfolio includes devices for lumbar applications (anterior, lateral, posterior; fixation, hardware and instrumentation); cervical (anterior and posterior) and biologics (allograft and synthetic bone)
  • Leadership brings experience from Abbott Spine, DePuy Spine, Genzyme Biosurgery, Johnson & Johnson, Medtronic, NuVasive, OrthoSpine Solutions, OsteoMed, RTI Biologics, Smith & Nephew Orthopaedics, Spinal Concepts, Zimmer Spine

Trauma

Endeavor Orthopaedics | Summit Patella Plating System, K203408

• Submitted November 2020, granted July 2021
• Primary predicate: Synthes’ SDB Cerclage System, K992616
• Includes implants and ancillary instruments for open reduction internal fixation of a patella fracture
• Reportedly the first and only patella fracture plating system utilizing the patented, fully integrated, soft tissue management feature Zip-
• Knot in a single-use surgical procedure kit
• Surgeon-invented product
  About the company:
  • Founded in 2019, based in Tulsa, Oklahoma, United States
  • Leadership has extensive orthopedic industry experience at Acumed, CarboFix, DePuy Synthes, Medartis, Sanofi

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