# K093442: Guided Growth System

- Pathway: 510(k) (Special)
- Applicant: Orthofix, Inc.
- Decided: Jun 10, 2010 after 217 days
- Product code: OBT (Plate, Bone, Growth Control, Pediatric, Epiphysiodesis)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K031493 (2003). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031493: Growth Guidance Plate, University of Utah/School of Medicine (2003) Summary page 1.

## Most influential descendants
- K172183: Guided Growth Plate System Plus (2018), 1 descendant of its own
- K171173: OrthoPediatrics Titanium PediPlates® System (2017), 1 descendant of its own
- K110805: Guided Growth System Eight-Plate, Quad-Plate (Stainless Steel) (2011), 1 descendant of its own
- K182704: WishBone Guided Growth System (2019), 0 descendants of its own
- K180624: Guided Growth Plate System Plus (2018), 0 descendants of its own

## Indications for use
The Guided Growth Plates are designed for the express and sole purpose of redirecting the angle of growth of long bone(s). This is useful for gradually correcting angular deformities in growing children. 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 (humerus), radial or ulnar deviation, flexion or extension deformities of the wrist (radius)

Source page: https://510kreport.com/device/K093442
Methodology: https://510kreport.com/methodology