Product Classification

• Device: prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
• Definition: This type of device is designed to allow for motion between the plastic bearing and metal baseplate components of a knee prosthesis. It is intended to replace a knee joint in order to relieve pain and restore knee function, for indications such as osteoarthritis, inflammatory arthritis, traumatic arthritis, and revision of failed knee prostheses.
• Review Panel: Orthopedic
• Product Code: NJL
• Premarket Review: Joint Arthroplasty Devices (DHT6A); Joint Arthroplasty Devices (DHT6A)
• 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

• 11-232 ISO 7207-1 Third edition 2007-02-01
  Implants for surgery - Components for partial and total knee joint prostheses - Part 1: Classification, definitions and designation of dimensions
• 11-308 ASTM F3161-16
  Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions
• 11-335 ASTM F3141-17a
  Standard Guide for Total Knee Replacement Loading Profiles
• 11-342 ASTM F732-17
  Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
• 11-361 ISO 14243-5 First edition 2019-05
  Implants for surgery - Wear of total knee prostheses - Part 5: Durability performance of the patellofemoral joint
• 11-368 ASTM F3334-19
  Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components
• 11-374 ISO 7207-2 Second edition 2011-07-01
  Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials [Including AMENDMENT 1 (2016) and AMENDMENT 2 (2020)]
• 11-377 ASTM F2083-21
  Standard Specification for Knee Replacement Prosthesis
• 11-391 ASTM F2722-21
  Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops
• 11-392 ASTM F2723-21
  Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation
• 11-393 ASTM F2724-21
  Standard Test Method for Evaluating Mobile Bearing Knee Dislocation
• 11-395 ASTM F1814-22
  Standard Guide for Evaluating Modular Hip and Knee Joint Components
• 11-397 ASTM F3210-22e1
  Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions
• 11-400 ISO 21536 Third edition 2023-07
  Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants
• 11-406 ASTM F3141-23
  Standard Guide for Total Knee Replacement Loading Profiles
• 11-408 ASTM F2777-23
  Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion

Third Party Review

Not Third Party Eligible