Product Classification

• Device: posterior cervical screw system
• Regulation Description: Posterior cervical screw system.
• Definition: Posterior cervical screw systems are intended for use in fusion procedures of the cervical spine and/or craniocervical junction and/or cervicothoracic junction for: 1) spinal fractures and dislocations; 2) deformities; 3) instabilities; 4) failed previous fusions; 5) tumors; 6) inflammatory disorders; 7) spinal degeneration, 8) facet degeneration with instability; and 9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to stabilize the spine in the absence of fusion for a limited time period in patients with tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
• Physical State: Metallic plates, longitudinal members (e.g., rods) and other device-specific accessories.
• Technical Method: Use of screws and longitudinal members (e.g., rods) to stabilization spinal segments for fusion.
• Target Area: Posterior cervical spine
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: NKG
• Premarket Review: Office of Orthopedic Devices (OHT6); Spinal Devices (DHT6B)
• Submission Type: 510(k)
• Regulation Number: 888.3075
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 11-276 ASTM F1798-13
  Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
• 11-346 ASTM F2706-18
  Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
• 11-369 ASTM F3292-19
  Standard Practice for Inspection of Spinal Implants Undergoing Testing
• 11-375 ASTM F2193-20
  Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
• 11-388 ASTM F1717-21
  Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
• 11-402 ASTM F1798-21
  Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants

Guidance Documents

• Classification of Posterior Cervical Screw Systems: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff

• Spinal System 510(k)s - Guidance for Industry and FDA Staff

Third Party Review

Not Third Party Eligible