# K093880: Peanut Growth Control Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, L.P.
- Decided: Apr 16, 2010 after 119 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- 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.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070823: Growth Control Plating System, Biomet Trauma (2007) Summary page 2.
- K031493: Growth Guidance Plate, University of Utah/School of Medicine (2003) Summary page 2.

## Recalls of this device
- Apr 1, 2016 · Class II · Z-1817-2016: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non

## Indications for use
The PeanutTm Growth Control Plating System is designed for redirecting the angle of growth of long bone(s) in pediatric patients (patients who have not had physeal closure/reached skeletal maturity). This is useful for gradually correcting angular deformities in pediatric patients with an open physis. 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, as well as radial or ulnar deviation, flexion or extension deformities of the wrist (radius).

Source page: https://510kreport.com/device/K093880
Methodology: https://510kreport.com/methodology