Prosthesis, Wrist, Constrained, Metal

Device Code: 4590

Product Code(s): KYN

Definition: Call For PMAs To Be Filed By 12/26/96 Per 61 FR 50711 On 9/27/96

Device Classification Information

• Device Type ID: 4590
• Device Name: Prosthesis, Wrist, Constrained, Metal
• Regulation Description: Wrist Joint Metal 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 Two ¿ Hips/Wrists/Fingers (JFDB2)
• Submission Type: PMA
• CFR Regulation Number: 888.3790 [🔎]
• FDA Device Classification: Class 3 Medical Device
• Product Code: KYN
• 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
• 11-294 ASTM F1357 -14
  Standard Specification For Articulating Total Wrist Implants

Total Product Life Cycle

• Device Type ID: 4590
• Device: Prosthesis, Wrist, Constrained, Metal
• Product Code: KYN
• FDA Device Classification: Class 3 Medical Device
• Regulation Description: Wrist Joint Metal Constrained Cemented Prosthesis.
• CFR Regulation Number: 888.3790 [🔎]

Device Problems
Break	1
Total Device Problems	1

TPLC Last Update: 2019-04-02 20:52:21