Product Classification

• Device: intervertebral fusion device with bone graft, lumbar
• Regulation Description: Intervertebral body fusion device.
• Definition: Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
• Physical State: hollow cylinder or rectangular box made of metal or polymer
• Technical Method: Acts as a disc spacer and holds bone graft.
• Target Area: intervertebral disc space
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: MAX
• Premarket Review: Office of Orthopedic Devices (OHT6); Spinal Devices (DHT6B)
• Submission Type: 510(k)
• Regulation Number: 888.3080
• 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

• 8-558 ASTM F3333-20
  Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) 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
• 11-185 ASTM F2267-04 (Reapproved 2018)
  Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
• 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
• 11-347 ASTM F2077-18
  Test Methods for Intervertebral Body Fusion Devices
• 11-369 ASTM F3292-19
  Standard Practice for Inspection of Spinal Implants Undergoing Testing
• 11-390 ISO 23089-2 First edition 2021-05
  Implants for surgery - Preclinical mechanical assessment of spinal implants and particular requirements - Part 2: Spinal intervertebral body fusion devices
• 11-418 ASTM F3631-24
  Standard Test Method for Assessment of Intra-operative Durability of Intervertebral Body Fusion Devices
• 11-421 ASTM F2077-24
  Standard Test Methods for Intervertebral Body Fusion Devices

Guidance Document

• Class II Special Controls Guidance Document: Intervertebral Body Fusion Device - Guidance for Industry and FDA Staff

Third Party Review

Not Third Party Eligible