# K180624: Guided Growth Plate System Plus

- Pathway: 510(k) (Special)
- Applicant: Orthofix Srl
- Decided: May 15, 2018 after 67 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: 3 generations back to K031493 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172183: Guided Growth Plate System Plus, Orthofix Srl (2018) Summary page 4.

## 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/K180624
Methodology: https://510kreport.com/methodology