# K220190: The GIRO Growth Modulation System

- Pathway: 510(k) (Traditional)
- Applicant: Pega Medical, Inc.
- Decided: Oct 24, 2022 after 273 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: 4 generations back to K993106 (1999). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090440: Hinge Pediatric Plating System, Pega Medical, Inc. (2009) Summary page 4.
- K151762: PediatrOS RigidTack/FlexTack, Merete Medical GmbH (2015) Summary page 4.

## Indications for use
The GIRO™ Growth Modulation System is intended as a temporary implant to aid in the correction of the angle of growth of long bones by modulating growth of the physis in pediatric (child and adolescent) patients. It is indicated for 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. Limb length discrepancy of the femur and tibia.

Source page: https://510kreport.com/device/K220190
Methodology: https://510kreport.com/methodology