Product Classification

• Device: prosthesis, knee, hinged (metal-metal)
• Regulation Description: Knee joint femorotibial metallic constrained cemented prosthesis.
• Definition: PMAs to be filed by 12/26/96 (61 FR 50710 (9/27/96))
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: HRZ
• Premarket Review: Office of Orthopedic Devices (OHT6); Joint Arthroplasty Devices (DHT6A)
• Submission Type: PMA
• Regulation Number: 888.3480
• 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

• 11-197 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
• 11-232 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
• 11-374 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)]
• 11-395 ASTM F1814-22
  Standard Guide for Evaluating Modular Hip and Knee Joint Components
• 11-400 ISO 21536 Third edition 2023-07
  Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants

Third Party Review

Not Third Party Eligible