# K260323: OrthoPediatrics® Locking Cannulated Blade Plate System

- Pathway: 510(k) (Traditional)
- Applicant: OrthoPediatrics Corp.
- Decided: Apr 30, 2026 after 90 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). 56 ancestors in all.
No later device cites it as a predicate yet.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110959: Orthopediatrics Blade Plate System, OrthoPediatrics Corp. (2011) Summary page 5.

## Indications for use
The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies.

Source page: https://510kreport.com/device/K260323
Methodology: https://510kreport.com/methodology