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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, wrist, 3 part metal-plastic-metal articulation, semi-constrained
Regulation Description Wrist joint metal/polymer semi-constrained cemented prosthesis.
Product CodeJWJ
Regulation Number 888.3800
Device Class 2


Premarket Reviews
ManufacturerDecision
AVANTA
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 2
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA
  SUBSTANTIALLY EQUIVALENT 1
KINETIKOS MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
MICK RADIO-NUCLEAR INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Protective measure issue 4
Implant, removal of 3
Naturally worn 3
Material erosion 2
Migration of device or device component 2
Patient-device incompatibility 2
Corrosion 1
Delivered as unsterile product 1
No Known Device Problem 1
Metal shedding debris 1
Device Contamination with biological material 1
Total Device Problems 21

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