# K090666: Pediplates

- Pathway: 510(k) (Traditional)
- Applicant: OrthoPediatrics Corp.
- Decided: Apr 24, 2009 after 42 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: 3 generations back to K993106 (1999). 10 ancestors in all.
15 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081407: Orthopediatrics Pediplates System, OrthoPediatrics Corp. (2008) Summary page 1.
- K073344: Orthopediatrics Plating System, Orthopediatrics, LLC (2008) Summary page 1.
- K031493: Growth Guidance Plate, University of Utah/School of Medicine (2003) Summary page 1.
- K020221: Iql Basic Fragment Plate Set, Iql Basic Fragment Screw Set, Iql Small Fragment Set, Iql Mini Fragment Set, Biomet Orthopedics, Inc. (2002) Summary page 1.
- K993106: Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories), Smith & Nephew, Inc. (1999) Summary page 1.
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 1.
- K013248: Synthes LCP Distal Tibia Plates, Synthes (Usa) (2001) Summary page 1.
- K080522: Synthes 3.5 MM LCP Distal Tibia T Plates, Synthes (Usa) (2008) Summary page 1.

## Most influential descendants
- K100240: Orthopediatrics Pediloc Tibia Plate System (2010), 13 descendants of its own
- 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

## Indications for use
The OrthoPediatrics PediPlateTM system is used for adult and pediatric patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include fractures of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius; middle hand and middle foot bones, treatment of the calcaneal; hip arthrodesis, 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/K090666
Methodology: https://510kreport.com/methodology