# K081407: Orthopediatrics Pediplates System

- Pathway: 510(k) (Traditional)
- Applicant: OrthoPediatrics Corp.
- Decided: Jul 22, 2008 after 64 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: 2 generations back to K993106 (1999). 6 ancestors in all.
65 later devices descend from it; 3 cite it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031493: Growth Guidance Plate, University of Utah/School of Medicine (2003) Summary page 1.
- K993106: Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories), Smith & Nephew, Inc. (1999) Summary page 1.
- K073344: Orthopediatrics Plating System, Orthopediatrics, LLC (2008) Summary page 1.
- K080522: Synthes 3.5 MM LCP Distal Tibia T Plates, Synthes (Usa) (2008). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K083286: Orthopediatrics Pediloc Locking Plate System (2009), 60 descendants of its own
- K120689: Synthes 3.5 MM VA-LCP Proximal Tibia Plate System (2012), 28 descendants of its own
- K090666: Pediplates (2009), 15 descendants of its own
- K163361: ANTHEM™ Fracture System (2017), 14 descendants of its own
- K100240: Orthopediatrics Pediloc Tibia Plate System (2010), 13 descendants of its own

## Indications for use
The OrthoPediatrics PediPlate system is used for adult and pediatric patients as indicated for pelvic, small and long bone fractures. Indications for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerous, ulna, middle hand and middle foot bones, treatment of the calcaneal; hip arthodesis, and provisional hole fixation; as well as for redirecting the angle of growth of long bones. This is useful for gradually correcting angular deformities in growing children. Specific pediatric conditions/diseases for which the devices 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 (humerus) • Radial or ulnar deviation, flexion or extension deformities of the wrist (radius)

Source page: https://510kreport.com/device/K081407
Methodology: https://510kreport.com/methodology