# K031493: Growth Guidance Plate

- Pathway: 510(k) (Traditional)
- Applicant: University of Utah/School of Medicine
- Decided: Nov 20, 2003 after 192 days
- Product code: HRS (Plate, Fixation, Bone)
- 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
No predicates in its family tree.
74 later devices descend from it; 8 cite it directly.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Blount Zimmalloy staple: named in the summary without a submission number

## Most influential descendants
- K081407: Orthopediatrics Pediplates System (2008), 65 descendants of its own
- K083286: Orthopediatrics Pediloc Locking Plate System (2009), 60 descendants of its own
- K120689: Synthes 3.5 MM VA-LCP Proximal Tibia Plate System (2012), 28 descendants of its own
- K090666: Pediplates (2009), 15 descendants of its own
- K163361: ANTHEM™ Fracture System (2017), 14 descendants of its own

## Indications for use
The Guided Growth Plate is 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/K031493
Methodology: https://510kreport.com/methodology