# K083286: Orthopediatrics Pediloc Locking Plate System

- Pathway: 510(k) (Traditional)
- Applicant: OrthoPediatrics Corp.
- Decided: Jan 30, 2009 after 86 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K962616 (1996). 35 ancestors in all.
60 later devices descend from it; 9 cite it directly.
0 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033669: Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws), Smith & Nephew, Inc. (2003) Summary page 1.
- K051735: Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity, Smith & Nephew, Inc. (2005) Summary page 1.
- K073344: Orthopediatrics Plating System, Orthopediatrics, LLC (2008) Summary page 1.
- K081407: Orthopediatrics Pediplates System, OrthoPediatrics Corp. (2008) Summary page 1.
- K062564: Synthes LCP Distal Femur Plates, Synthes (Usa) (2006) Summary page 1.

## Most influential descendants
- K120689: Synthes 3.5 MM VA-LCP Proximal Tibia Plate System (2012), 28 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
- K173166: ANTHEM Fracture System (2017), 11 descendants of its own
- K180554: ANTHEM Fracture System (2018), 10 descendants of its own

## Recalls of this device
- Jul 27, 2016 · Class II · Z-2844-2016: OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-hole Plate and 18-hole Plate due to the devices being mislabeled.
- Jul 27, 2016 · Class II · Z-2843-2016: OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-hole Plate and 18-hole Plate due to the devices being mislabeled.
- Jul 24, 2013 · Class II · Z-1941-2013: OrthoPediatrics has initiated a voluntary recall of Part # 01-1050-002, 2.5mm Drill Bit, Lot #91300335. Only drill bits that are in their original packaging are being recalled. The description on the 
- Oct 18, 2012 · Class II · Z-0432-2013: Complaint received from sales representative that the drill guide tubes would not screw into replenishment instrument. Upon investigation, it has been determined that the device was not manufactured t
- Jun 14, 2012 · Class II · Z-2057-2012: The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device.

## Indications for use
The OrthoPediatrics PediLocTM Locking Plate System is used for pediatric patients as indicated for pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle. Indications for buttressing multi- fragmentary distal femoral fractures include: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, non-unions and mal-unions, and osteotomies of the femur.

Source page: https://510kreport.com/device/K083286
Methodology: https://510kreport.com/methodology