Prosthesis, Wrist, Carpal Trapezium

Device Code: 4586

Product Code(s): KYI

Device Classification Information

• Device Type ID: 4586
• Device Name: Prosthesis, Wrist, Carpal Trapezium
• Regulation Description: Wrist Joint Carpal Trapezium Polymer 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: 510(k)
• CFR Regulation Number: 888.3770 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: KYI
• 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

Total Product Life Cycle

• Device Type ID: 4586
• Device: Prosthesis, Wrist, Carpal Trapezium
• Product Code: KYI
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Wrist Joint Carpal Trapezium Polymer Prosthesis.
• CFR Regulation Number: 888.3770 [🔎]

Premarket Reviews
Manufacturer	Decision
SKELETAL DYNAMICS, LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Break	2
Adverse Event Without Identified Device Or Use Problem	2
Migration Or Expulsion Of Device	1
Total Device Problems	5

TPLC Last Update: 2019-04-02 20:52:17