# K141103: Intramedullary Nail and Screws-Neonail

- Pathway: 510(k) (Traditional)
- Applicant: Neoortho Produtos Ortopedicos S/A
- Decided: Sep 23, 2014 after 147 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K951740 (1995). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010801: T2 Femoral Nail, Howmedica Osteonics Corp. (2001) Summary page 6.
- K112059: T2 Femoral Nail Model 1825-Xxxxcp, 1828-Xxxxcp, Stryker (2011) Summary page 6.
- K131365: T2 Tibial Nailing System, Stryker Trauma AG (2013) Summary page 6.
- K042396: T2 Proximal Humeral Nail, Howmedica Osteonics Corp. (2004) Summary page 6.
- K032523: T2 Nailing System, Howmedica Osteonics Corp. (2003) Summary page 6.

## Most influential descendants
- K221021: Femoral Trochanteric Nail System – Neonail (2022), 0 descendants of its own

## Indications for use
Intramedullary Nail and Screws for Femur – NEONAIL is indicated for femoral fracture fixation including: • Open and closed femoral fractures; • Pseudoarthrosis and correction osteotomy; • Pathologic fractures, impending pathologic fractures, and tumor resections; • Ipsilateral femur fractures; • Fractures distal to the hip joint; and • Nonunions and malunions. Intramedullary Nail and Screws for Tibia – NEONAIL is intended to provide temporary stabilization of various types of fractures, malunions or nonunions of the tibia. Intramedullary Nail and Screws for Tibia – NEONAIL is indicated for tibial fracture fixation, which may include: • Open and closed tibial fractures; • Pseudoarthodlosis and correction osteotomy; • Pathologic fractures, impending pathologic fractures and tumor resections; and • Nonunions and malunions. The Intramedullary Nail and Screws for Humerus – NEONAIL is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include nonunions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications include: AO classification Type A fractures, dislocated; AO classification Type B fractures, dislocated; AO classification Type C fractures with intact calotte; and humeral fractures according to the Neer Classification.

Source page: https://510kreport.com/device/K141103
Methodology: https://510kreport.com/methodology