Prosthesis, Finger, Constrained, Polymer

Device Code: 4587

Product Code(s): KYJ

Device Classification Information

• Device Type ID: 4587
• Device Name: Prosthesis, Finger, Constrained, Polymer
• Regulation Description: Finger Joint Polymer Constrained 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: 888.3230 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: KYJ
• 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
• 11-305 ASTM F1781-15
  Standard Specification For Elastomeric Flexible Hinge Finger Total Joint Implants

Total Product Life Cycle

• Device Type ID: 4587
• Device: Prosthesis, Finger, Constrained, Polymer
• Product Code: KYJ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Finger Joint Polymer Constrained Prosthesis.
• CFR Regulation Number: 888.3230 [🔎]

Premarket Reviews
Manufacturer	Decision
OSTEOTEC LTD
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Break	11
Fracture	11
Material Integrity Problem	5
Adverse Event Without Identified Device Or Use Problem	2
Device Dislodged Or Dislocated	1
Product Quality Problem	1
Incorrect Device Or Component Shipped	1
Device Contaminated During Manufacture Or Shipping	1
Total Device Problems	33

TPLC Last Update: 2019-04-02 20:52:18