# K192619: Pitkar Locked Plating System

- Pathway: 510(k) (Traditional)
- Applicant: S.H.Pitkar Orthotools Pvt., Ltd.
- Decided: Feb 27, 2020 after 157 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: 12 generations back to K962616 (1996). 105 ancestors in all.
No later device cites it as a predicate yet.
0 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153374: CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System, Orthocare (2016) Summary page 4.
- K013248: Synthes LCP Distal Tibia Plates, Synthes (Usa) (2001) Summary page 4.
- K030597: Synthes 3.5MM Titanium LCP Proximal Tibia Plates, Synthes (Usa) (2003) Summary page 4.
- K062564: Synthes LCP Distal Femur Plates, Synthes (Usa) (2006) Summary page 4.
- K033995: 3.5 MM LCP Distal Humerus System, Synthes (Usa) (2004) Summary page 4.
- K011815: Synthes LCP Proximal Humerus Plates, Synthes (Usa) (2001) Summary page 4.
- K012114: Synthes Locking Distal Radius Plating System, Synthes (Usa) (2001) Summary page 4.
- K073186: Synthes 3.5MM LCP Clavicle Plate System, Synthes (Usa) (2007) Summary page 4.

## Indications for use
Pitkar Locked Plating System is indicated for fixation of fractures, osteotomies and non-unions of various bones including the humerus, radius, ulna, femur, tibia, fibula and clavicle, including in osteopenic bone.

Source page: https://510kreport.com/device/K192619
Methodology: https://510kreport.com/methodology