Product Classification

• Device: orthosis, spinal pedicle fixation
• Regulation Description: Thoracolumbosacral pedicle screw system.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: MNI
• 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

• 8-195 ASTM F2024-10 (Reapproved 2016)
  Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
• 8-475 ASTM F2026-17
  Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
• 8-574 ASTM F2820-12(2021)e1
  Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications
• 8-577 ISO 13179-1 Second Edition 2021-09
  Implants for surgery -- Coatings on metallic surgical implants -- Part 1: Plasma-sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders
• 8-609 ASTM F2026-23
  Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
• 11-197 ASTM F983-86 (Reapproved 2018)
  Standard Practice for Permanent Marking of Orthopaedic Implant Components
• 11-199 ASTM F565-04 (Reapproved 2018)
  Standard Practice for Care and Handling of Orthopedic Implants and Instruments
• 11-369 ASTM F3292-19
  Standard Practice for Inspection of Spinal Implants Undergoing Testing
• 11-388 ASTM F1717-21
  Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

Guidance Document

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

Third Party Review

Not Third Party Eligible