OBT

6 FDA 510(k) clearances · Product code

FDA profile

Official device name

Plate, Bone, Growth Control, Pediatric, Epiphysiodesis

Device class

Class II (moderate risk)

Regulation

21 CFR 888.3030

Medical specialty

Orthopedic

Flags

Implant · Life-sustaining

FDA 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.

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