Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
FDA product code OBT · Class II (moderate risk) · 21 CFR 888.3030 · Orthopedic
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.
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220190 | The GIRO Growth Modulation SystemOBT · Traditional | Pega Medical, Inc. | 10/24/2022SE |
| K182704 | WishBone Guided Growth SystemOBT · Traditional | Wishbone Medical | 06/25/2019SE |
| K180624 | Guided Growth Plate System PlusOBT · Special | Orthofix Srl | 05/15/2018SE |
| K172183 | Guided Growth Plate System PlusOBT · Traditional | Orthofix Srl | 01/09/2018SE |
| K110805 | Guided Growth System Eight-Plate, Quad-Plate (Stainless Steel)OBT · Special | Orthofix, Inc. | 06/21/2011SE |
| K093442 | Guided Growth SystemOBT · Special | Orthofix, Inc. | 06/10/2010SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1808-2024 Class II | WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.The products in this lot are incorrectly packed with a Stainless-Steel implant instead of a Titanium implant… | Wishbone Medical, Inc. | 04/05/2024Open, Classified |