# K171173: OrthoPediatrics Titanium PediPlates® System

- Pathway: 510(k) (Traditional)
- Applicant: OrthoPediatrics Corp.
- Decided: Aug 24, 2017 after 125 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
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
- K182704: WishBone Guided Growth System (2019), 0 descendants of its own

## Indications for use
The OrthoPediatrics Titanium PediPlates® System is used 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/K171173
Methodology: https://510kreport.com/methodology