# K172183: Guided Growth Plate System Plus

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix Srl
- Decided: Jan 9, 2018 after 174 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: 2 generations back to K031493 (2003). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093442: Guided Growth System, Orthofix, Inc. (2010) Summary page 4.

## Most influential descendants
- K180624: Guided Growth Plate System Plus (2018), 0 descendants of its own

## Indications for use
The Guided Growth Plate System Plus is intended for redirecting the growth of long bones. It is indicated for gradually correcting angular growth 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), and radial or ulnar deviation, flexion or extension deformities of the wrist (radius).

Source page: https://510kreport.com/device/K172183
Methodology: https://510kreport.com/methodology