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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device plate, bone, growth control, pediatric, epiphysiodesis
Definition Intended to redirect the angle of growth of long bone(s) only in pediatric patients. Indicated for temporary or permanent epiphysiodesis. For gradually correcting angular deformities of long bones in pediatric patients with an open physis. Specific conditions/diseases for which the device will be indicated include valgus, varus, or flexion extension deformities of the knee (femur and/or tibia); valgus, varus or plantar flexion deformities of the ankle, valgus or varus deformities of the elbow, as well as radial or ulnar deviation, flexion or extension deformities of the wrist (radius). The device may be removed when growth has equalized or the growth plate has fused.
Product CodeOBT
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
PEGA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
WISHBONE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 3 3
2021 1 1
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 3 3
Device Dislodged or Dislocated 1 1
Material Twisted/Bent 1 1
Insufficient Information 1 1
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
Failure of Implant 1 1
Foreign Body In Patient 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Wishbone Medical, Inc. II May-10-2024
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