# K110959: Orthopediatrics Blade Plate System

- Pathway: 510(k) (Traditional)
- Applicant: OrthoPediatrics Corp.
- Decided: Aug 5, 2011 after 122 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 3 (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). 55 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083286: Orthopediatrics Pediloc Locking Plate System, OrthoPediatrics Corp. (2009) Summary page 1.
- K100240: Orthopediatrics Pediloc Tibia Plate System, OrthoPediatrics Corp. (2010) Summary page 1.
- K082949: Orthopediatrics Bone Screws, OrthoPediatrics Corp. (2008) Summary page 1.
- K993289: Smith & Nephew Compression Hip Screw System, Intramedullary Hip Screw System, Smith & Nephew, Inc. (1999) Summary page 1.
- (no number) Pre Ammendment - Osteotomy / Blade Plates, Smith & Nephew: named in the summary without a submission number

## Most influential descendants
- K260323: OrthoPediatrics® Locking Cannulated Blade Plate System (2026), 0 descendants of its own
- K170704: The Locking Pediatric Osteotomy Plate (LolliPOP) System (2017), 0 descendants of its own

## Recalls of this device
- Apr 19, 2013 · Class II · Z-1535-2013: Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively.
- Apr 19, 2013 · Class II · Z-1536-2013: Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively.
- Apr 19, 2013 · Class II · Z-1534-2013: Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively.

## Indications for use
The OrthoPediatrics 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/K110959
Methodology: https://510kreport.com/methodology