# K090440: Hinge Pediatric Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Pega Medical, Inc.
- Decided: May 20, 2009 after 89 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: 3 generations back to K993106 (1999). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 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) Summary page 2.
- K081407: Orthopediatrics Pediplates System, OrthoPediatrics Corp. (2008) Summary page 2.
- K070823: Growth Control Plating System, Biomet Trauma (2007) Summary page 2.

## Most influential descendants
- K220190: The GIRO Growth Modulation System (2022), 0 descendants of its own

## Indications for use
The Hinge Pediatric Plating System is indicated as a temporary implant to aid in the correction of the angle of growth of long bones by inhibiting longitudinal growth of the physis in pediatric patients. It can be used to correct the following conditions: * Femur and tibia: varus, valgus, flexion or extension deformities of the knee. * Humerus: valgus or varus deformities of the elbow. * Radius and Ulna: flexion or extension deformities of the wrist. * Ankle: varus, valgus or plantar flexion deformities of the ankle.

Source page: https://510kreport.com/device/K090440
Methodology: https://510kreport.com/methodology