# K150561: NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Narang Medical Limited
- Decided: Nov 25, 2015 after 264 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: 11 generations back to K962616 (1996). 97 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 99 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011815: Synthes LCP Proximal Humerus Plates, Synthes (Usa) (2001) Summary page 7.
- K033995: 3.5 MM LCP Distal Humerus System, Synthes (Usa) (2004) Summary page 7.
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 7.
- K061753: Synthes (Usa) Clavicle Hook Plates, Synthes (Usa) (2006) Summary page 7.
- K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications, Synthes (Usa) (2008) Summary page 8.
- K030858: Synthes (Usa) LCP Proximal Femur Plate and Screws, Synthes (Usa) (2003) Summary page 8.
- K062564: Synthes LCP Distal Femur Plates, Synthes (Usa) (2006) Summary page 8.
- K011978: Synthes LCP Proximal Tibia Plate, Synthes (Usa) (2001) Summary page 8.
- K023802: Synthes 4.5 MM Titanium LCP Proximal Tibia Plating System, Synthes (Usa) (2003) Summary page 8.
- K051986: Synthes 4.5 MM LCP Straight Reconstruction Plates, Synthes (Usa) (2005) Summary page 8.
- K000682: Synthes Large Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 8.
- K923613: Synthes Limited Contact-Dynamic Hip Screw Implant, Synthes (Usa) (1993) Summary page 9.
- K953607: Titanium Limited Contact Dynamic Hip Screw Plate (Tilc-DHS), Synthes (Usa) (1996) Summary page 9.
- K840954: Dynamic Condylar Screw or D.C.S., Synthes (Usa) (1984) Summary page 9.
- K112583: Synthes Cortical Screws, Synthes (USA) Products, LLC (2011) Summary page 9.

## Most influential descendants
- K163425: NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System (2017), 0 descendants of its own

## Indications for use
NET Brand Small Fragment and Large Fragment Osteosynthesis System is intended for small and large bone fracture fixation, arthrodesis and osteotomy fixation. Examples include: fractures of the clavicle, scapula, humerus, olecranon, radius, ulna, distal femur, proximal tibia, tibial pilon, fibula, pelvis and acetabulum fractures; periprosthetic fractures; The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone. This system is not indicated for use in the spine. NET Brand DHS/DCS plating system may be used for fixation of the fractures of proximal femur such as femoral neck, trochanteric, pertrochanteric or intertrochanteric zones. The system is indicated for use in adult patients only. All implants are for single use only.

Source page: https://510kreport.com/device/K150561
Methodology: https://510kreport.com/methodology