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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device knee arthroplasty implantation system
Definition Intended to be used to assist in the implantation of a specific knee arthroplasty device or a set of specific knee arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.
Product CodeOOG
Regulation Number 888.3560
Device Class 2


Premarket Reviews
ManufacturerDecision
CONFORMIS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 2 2
2019 15 15
2020 8 8
2021 4 4
2022 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Break 12 12
Compatibility Problem 12 12
Loosening of Implant Not Related to Bone-Ingrowth 11 11
Adverse Event Without Identified Device or Use Problem 5 5
Patient Device Interaction Problem 3 3
Material Deformation 1 1
Device Fell 1 1
Crack 1 1
Material Separation 1 1
Loss of Osseointegration 1 1
Defective Device 1 1
Application Network Problem 1 1
Biocompatibility 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 17 17
Unspecified Infection 13 13
Limited Mobility Of The Implanted Joint 13 13
Patient Problem/Medical Problem 12 12
Failure of Implant 11 11
No Clinical Signs, Symptoms or Conditions 6 6
Insufficient Information 4 4
No Known Impact Or Consequence To Patient 3 3
Inadequate Osseointegration 3 3
Joint Disorder 3 3
No Consequences Or Impact To Patient 2 2
Ambulation Difficulties 1 1
Sepsis 1 1
No Information 1 1
Bone Fracture(s) 1 1
Hemorrhage/Bleeding 1 1
Cyst(s) 1 1
Hematoma 1 1
Inflammation 1 1

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