Prosthesis, Knee, Hinged (metal-metal)

Device Code: 4465

Product Code(s): HRZ

Definition: PMAs To Be Filed By 12/26/96 (61 FR 50710 (9/27/96))

Device Classification Information

• Device Type ID: 4465
• Device Name: Prosthesis, Knee, Hinged (metal-metal)
• Regulation Description: Knee Joint Femorotibial Metallic Constrained Cemented Prosthesis.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Orthopedic Devices (DOD); Joint And Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1)
• Submission Type: PMA
• CFR Regulation Number: 888.3480 [🔎]
• FDA Device Classification: Class 3 Medical Device
• Product Code: HRZ
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: Yes
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized 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
• 11-306 ASTM F1814-15
  Standard Guide For Evaluating Modular Hip And Knee Joint Components
• 11-313 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)]

Total Product Life Cycle

• Device Type ID: 4465
• Device: Prosthesis, Knee, Hinged (metal-metal)
• Product Code: HRZ
• FDA Device Classification: Class 3 Medical Device
• Regulation Description: Knee Joint Femorotibial Metallic Constrained Cemented Prosthesis.
• CFR Regulation Number: 888.3480 [🔎]

Device Problems
Break	2
Incorrect Device Or Component Shipped	1
Device Dislodged Or Dislocated	1
Total Device Problems	4

TPLC Last Update: 2019-04-02 20:49:49