DeviceClearance

Product code OBT— Orthopedic

Guided Growth Plate System Plus

Classification name
Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
Device class
Class 2
Regulation
21 CFR 888.3030
Advisory panel
Orthopedic
Total cleared
6
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code OBT under 21 CFR 888.3030, via openFDA

Market context for product code OBT

FDA has cleared 6 devices under product code OBT between 2010 and 2022, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OBT

Recent clearances under product code OBT

Data sourced from openFDA. This site is unofficial and independent of the FDA.