# K110805: Guided Growth System Eight-Plate, Quad-Plate (Stainless Steel)

- Pathway: 510(k) (Special)
- Applicant: Orthofix, Inc.
- Decided: Jun 21, 2011 after 90 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)
- K031493: Growth Guidance Plate, University of Utah/School of Medicine (2003). Our reading of the summary gave K031439, FDA’s number for Alginate Impression Material Iii (Fast & Regular) (Harry J. Bosworth Co.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Growth Guidance Plate (eight-Plate)”. Summary page 2.
- K093442: Guided Growth System, Orthofix, Inc. (2010) Summary page 1.

## Most influential descendants
- K182704: WishBone Guided Growth System (2019), 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, vanjs or flexion; extension deformities of the knee (femur and/or tibia), valgus, vanis or plantar fiexion deformities of the ankle, valgus or vanis deformities of the elbow (humerus), radial or ulnar deviation, flexion or extension deformities of the wrist (radius).

Source page: https://510kreport.com/device/K110805
Methodology: https://510kreport.com/methodology