Product Classification

• Device: growing rod system- magnetic actuation
• Regulation Description: Thoracolumbosacral pedicle screw system.
• Definition: Stabilization or correction of spinal deformities without the use of fusion, using non-invasive methods to adjust the spinal rod.
• Physical State: Metalllic rods, monoaxial or polyaxial bone screws, hooks, magnetic remote control, and other related accessories.
• Technical Method: The system of distracting rods and fixation elements (screws, hooks, etc.) provides stabilization of severe spinal abnormalities and distraction of the rod as the child grows, via magnetic actuation.
• Target Area: Pediatric spine
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: PGN
• Premarket Review: Office of Orthopedic Devices (OHT6); Spinal Devices (DHT6B)
• Submission Type: 510(k)
• Regulation Number: 888.3070
• 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
• 11-402 ASTM F1798-21
  Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants

Third Party Review

Not Third Party Eligible