# K100240: Orthopediatrics Pediloc Tibia Plate System

- Pathway: 510(k) (Traditional)
- Applicant: OrthoPediatrics Corp.
- Decided: May 17, 2010 after 110 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: 8 generations back to K962616 (1996). 39 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080522: Synthes 3.5 MM LCP Distal Tibia T Plates, Synthes (Usa) (2008) Summary page 1.
- K083286: Orthopediatrics Pediloc Locking Plate System, OrthoPediatrics Corp. (2009) Summary page 1.
- K090666: Pediplates, OrthoPediatrics Corp. (2009). Our reading of the summary gave K090665, FDA’s number for Emboshield NAV6 Embolic Protection System-Small/Large… (Abbott Vascular-Vascular Solutions). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “PediPlate System, OrthoPediatrics”.

## Most influential descendants
- K111086: Orthopediatrics Fracture and Osteotomy Bone Plate System (2011), 7 descendants of its own
- K192181: PRECICE Plating System (2019), 2 descendants of its own
- K110959: Orthopediatrics Blade Plate System (2011), 2 descendants of its own
- K200246: JPS JuniOrtho Plating System (2020), 1 descendant of its own
- K162307: OrthoPediatrics Locking Proximal Femur System Cortical Screws (2016), 1 descendant of its own

## Indications for use
OrthoPediatrics PediLocTm Tibia Plates are indicated for fractures, osteotomies, and non-unions of the pediatric and small stature adult tibia.

Source page: https://510kreport.com/device/K100240
Methodology: https://510kreport.com/methodology