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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, knee, patello/femoral, semi-constrained, cemented, metal/polymer
Regulation Description Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.
Product CodeKRR
Regulation Number 888.3540
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
BIOMET
  SUBSTANTIALLY EQUIVALENT 2
KINAMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAKO SURGICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 4
SULZER
  SUBSTANTIALLY EQUIVALENT 1
TORNIER
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No code available 1
Total Device Problems 1

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