Cleared Traditional

K182704 - WishBone Guided Growth System (FDA 510(k) Clearance)

K182704 · Wishbone Medical · Orthopedic device
Jun 2019
Decision
271d
Days
Class 2
Risk

K182704 is an FDA 510(k) clearance for the WishBone Guided Growth System. This device is classified as a Plate, Bone, Growth Control, Pediatric, Epiphysiodesis (Class II - Special Controls, product code OBT).

Submitted by Wishbone Medical (Warsaw, US). The FDA issued a Cleared decision on June 25, 2019, 271 days after receiving the submission on September 27, 2018.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030. 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..

Submission Details

510(k) Number K182704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2018
Decision Date June 25, 2019
Days to Decision 271 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code OBT - Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
Device Class Class II - Special Controls
CFR Regulation 21 CFR 888.3030
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.