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U.S. Department of Health and Human Services

Product Classification

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Device plate, bone, growth control, pediatric, epiphysiodesis
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
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.
Physical State Metallic bone fixation appliances and accessories
Technical Method Mechanical bone fixation
Target Area Long bone growth plates only. Spinal indications require additional testing, labeling and an different product code.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeOBT
Premarket Review Stereotaxic, Trauma and Restorative Devices (DHT6C)
Stereotaxic, Trauma and Restorative Devices (DHT6C)
Submission Type 510(k)
Regulation Number 888.3030
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? Yes
Life-Sustain/Support Device? Yes
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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