# K233150: NET BRAND Osteosynthesis Nailing System

- Pathway: 510(k) (Traditional)
- Applicant: Narang Medical, Ltd.
- Decided: Feb 20, 2024 after 146 days
- Product code: JDS (Nail, 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: 3 generations back to K960642 (1996). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914453: Universal Tibial Nail and Unreamed Tibial Nail, Synthes (Usa) (1992) Summary page 7.
- K962047: Titanium Cannulated Tibial Nail (TI CTN), Synthes (Usa) (1996) Summary page 7.
- K040336: Synthes (Usa) Lateral Entry Femoral Nail System, Synthes (Usa) (2004) Summary page 7.
- K954856: Cannulated Femoral Nail, Synthes (Usa) (1996) Summary page 7.
- K011857: Synthes (Usa) Trochanteric Fixation Nail (TFN) System, Synthes (Usa) (2001) Summary page 7.
- K070294: Synthes Trochanteric Fixation Nail (TFN) System, Additional Helical Blades, Synthes (Usa) (2007) Summary page 7.
- K971783: Synthes Elastic Intramedullary Nail (Ein) System, Synthes (Usa) (1997) Summary page 8.
- K032687: Ace Nancy Nail, DePuy Orthopaedics, Inc. (2003) Summary page 8.

## Indications for use
NET BRAND Osteosynthesis Nailing System are provided non-sterile. Tibial Nails are indicated for stabilization of fractures of proximal and distal tibia, tibial shaft, open and closed tibial shaft fractures, certain pre and postisthmic fractures, non-unions and malunions. Femoral Nails are indicated for stabilization of femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions. The Elastic Nails are indicated for fixation of diaphyseal fractures of the long bones where the medullary canal is narrow or the flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in paediatric or small statured patients. In paediatric applications, the flexibility of the elastic intramedullary nailing allows it to be inserted at a point which avoids disruption of the bone growth plate. All Implants are for single use only.

Source page: https://510kreport.com/device/K233150
Methodology: https://510kreport.com/methodology