Prosthesis, Elbow, Hemi-, Humeral, Metal

Device Code: 4568

Product Code(s): KWJ

Definition: Call For Pmas To Be Filed By 12/26/96 Per 61 FR 50709 On 9/27/96

Device Classification Information

• Device Type ID: 4568
• Device Name: Prosthesis, Elbow, Hemi-, Humeral, Metal
• Regulation Description: Elbow Joint Humeral (hemi-elbow) Metallic Uncemented 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: 888.3180 [🔎]
• FDA Device Classification: Class 3 Medical Device
• Product Code: KWJ
• 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
• 11-321 ASTM F2887-17
  Standard Specification For Total Elbow Prostheses

Total Product Life Cycle

• Device Type ID: 4568
• Device: Prosthesis, Elbow, Hemi-, Humeral, Metal
• Product Code: KWJ
• FDA Device Classification: Class 3 Medical Device
• Regulation Description: Elbow Joint Humeral (hemi-elbow) Metallic Uncemented Prosthesis.
• CFR Regulation Number: 888.3180 [🔎]

Device Problems
Naturally Worn	1
Insufficient Information	1
Total Device Problems	2

TPLC Last Update: 2019-04-02 20:51:54