# K140431: Pediloc Fragment System

- Pathway: 510(k) (Traditional)
- Applicant: OrthoPediatrics Corp.
- Decided: Jul 29, 2014 after 159 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: 10 generations back to K962616 (1996). 64 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111086: Orthopediatrics Fracture and Osteotomy Bone Plate System, OrthoPediatrics Corp. (2011) Summary page 1.
- K083286: Orthopediatrics Pediloc Locking Plate System, OrthoPediatrics Corp. (2009) Summary page 1.
- K082949: Orthopediatrics Bone Screws, OrthoPediatrics Corp. (2008) Summary page 1.
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 1.

## Most influential descendants
- K252600: Pediatric Plating Platform I Small-Mini (2025), 0 descendants of its own

## Indications for use
OrthoPedlatrics' PediLoc Fragment System is intended to provide temporary internal fixation and stabilization of long bones, short (small) bones, pelvs, and scapula. This Includes fractures, osteotomles, mal-unlons, and non-unions in all pediatric subgroups (except neonates), and small stature adults.

Source page: https://510kreport.com/device/K140431
Methodology: https://510kreport.com/methodology