510(k) K182704

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

June 25, 2019

Date Received

September 27, 2018

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Plate, Bone, Growth Control, Pediatric, Epiphysiodesis

Device Class

Class II

Regulation Number

888.3030

Review Panel

OR

Submission Type

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.