# K111086: Orthopediatrics Fracture and Osteotomy Bone Plate System

- Pathway: 510(k) (Traditional)
- Applicant: OrthoPediatrics Corp.
- Decided: Jun 17, 2011 after 59 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K962616 (1996). 63 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062872: Synthes (Usa) Pediatric LCP Hip Plate System, Synthes (Usa) (2007) Summary page 2.
- K072095: Synthes (Usa) Pediatric LCP Hip Plate System Modifications, Synthes (Usa) (2007) Summary page 2.
- K083286: Orthopediatrics Pediloc Locking Plate System, OrthoPediatrics Corp. (2009) Summary page 2.
- K082949: Orthopediatrics Bone Screws, OrthoPediatrics Corp. (2008) Summary page 2.
- K100240: Orthopediatrics Pediloc Tibia Plate System, OrthoPediatrics Corp. (2010) Summary page 2.
- K070906: Modificaton to: Zimmer Periarticular Locking Plates and Screws, Zimmer, Inc. (2007) Summary page 2.
- K003496: Cannulated Screw System, Pioneer Surgical Technology (2001) Summary page 2.

## Most influential descendants
- K192181: PRECICE Plating System (2019), 2 descendants of its own
- K162307: OrthoPediatrics Locking Proximal Femur System Cortical Screws (2016), 1 descendant of its own
- K140431: Pediloc Fragment System (2014), 1 descendant of its own
- K252600: Pediatric Plating Platform I Small-Mini (2025), 0 descendants of its own
- K243963: Pediatric Plating Platform  Hip (2025), 0 descendants of its own

## Recalls of this device
- Jul 28, 2015 · Class II · Z-2796-2015: The 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw, Lot # 150192-J package may contain a different screw. The screw in the package is a 00-0903-2526, 3.5mm x 26mm, and is etched correctly.

## Indications for use
The Orthoediatrics Fracture and Osteotomy Bone Plate System is intended for temporary internal fixation and stabilization of long bone fractures and osteotomies, mal-unions and non-unions, in pediatric and small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies.

Source page: https://510kreport.com/device/K111086
Methodology: https://510kreport.com/methodology