OBT — Plate, Bone, Growth Control, Pediatric, Epiphysiodesis Class II

FDA Device Classification

Classification Details

Product Code
OBT
Device Class
Class II
Regulation Number
888.3030
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K220190pega medicalThe GIRO Growth Modulation SystemOctober 24, 2022
K182704wishbone medicalWishBone Guided Growth SystemJune 25, 2019
K180624orthofixGuided Growth Plate System PlusMay 15, 2018
K172183orthofixGuided Growth Plate System PlusJanuary 9, 2018
K110805orthofixGUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL)June 21, 2011
K093442orthofixGUIDED GROWTH SYSTEMJune 10, 2010