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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device orthopedic computer controlled surgical system
Definition Pre-operative planning and intra-operative execution of surgical movements with robotically controlled end effectors under user supervision. Alternative to manual planning and broaching/reaming techniques for femoral canal preparation in primary total hip arthroplasty (THA).
Product CodeOJP
Regulation Number 882.4560
Device Class 2


Premarket Reviews
ManufacturerDecision
CUREXO TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
THINK SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 2 2
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Improper or Incorrect Procedure or Method 1 1
Defective Component 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2
Insufficient Information 1 1

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