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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ankle arthroplasty implantation system
Definition Intended to be used to assist in the implantation of a specific ankle arthroplasty device. Indicated to include guiding alignment, making or establishing cuts, and sizing.
Product CodeOYK
Regulation Number 888.3110
Device Class 2


Premarket Reviews
ManufacturerDecision
3D SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
3D SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RESTOR3D
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 4 4
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Loss of or Failure to Bond 2 2
Naturally Worn 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Cyst(s) 4 4
Pain 4 4
Numbness 4 4
Swelling/ Edema 4 4
Ambulation Difficulties 3 3
Joint Laxity 3 3
Loss of Range of Motion 3 3
Muscular Rigidity 3 3
Fatigue 3 3
Failure of Implant 1 1
Inflammation 1 1
Adhesion(s) 1 1
Osteolysis 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Integra LifeSciences Corp. II Mar-02-2012
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