Product Classification

• Device: prosthesis, intervertebral disc
• Review Panel: Orthopedic
• Product Code: MJO
• Premarket Review: Spinal Devices (DHT6B); Spinal Devices (DHT6B)
• Submission Type: PMA
• Device Class: 3
• 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
• 11-185 ASTM F2267-04 (Reapproved 2018)
  Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
• 11-269 ASTM F2423-11 (Reapproved 2020)
  Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
• 11-274 ISO 18192-2 First edition 2010-06-15
  Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 2: Nucleus replacements
• 11-343 ASTM F2346-18
  Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
• 11-351 ISO 18192-1 Second edition 2011-03-01
  Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test [Including AMENDMENT 1 (2018)]
• 11-353 ISO 18192-3 First edition 2017-06
  Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar prostheses under adverse kinematic conditions
• 11-354 ASTM F3295-18
  Standard Guide for Impingement Testing of Total Disc Prostheses
• 11-369 ASTM F3292-19
  Standard Practice for Inspection of Spinal Implants Undergoing Testing

Third Party Review

Not Third Party Eligible