# K141347: Emerge Medical IM Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Emerge Medical
- Decided: Oct 2, 2014 after 133 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: 12 generations back to K962616 (1996). 100 ancestors in all.
No later device cites it as a predicate yet.
0 of 101 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081152: T2 Femoral Nail, Howmedica Osteonics Corp. (2008) Summary page 4.
- K003018: Titan Tibial Nail, Howmedica Osteonics Corp. (2000) Summary page 4.
- K043404: Modification to T2 Proximal Humeral Nail, Howmedica Osteonics Corp. (2004) Summary page 4.
- K122489: Emerge Medical Solid Bone Screws, Emerge Medical (2012) Summary page 4.
- K140119: Emerge Medical Periarticular and Locking Large Fragment System, Emerge Medical (2014) Summary page 4.

## Indications for use
The Emerge Medical IM Nail System is intended to provide temporary stabilization in long bones including the femur, tibia and humerus of various types of open or closed fractures including malunions, nonunions (pseudoarthrosis), correction osteotomy including malalignment, pathologic fractures, impending pathologic fractures, and tumor resections of specific bones. Specific Femoral indications may include supracondylar fractures, including those with intra-articular extension, Ipsilateral femur fractures, fractures proximal to a total knee arthroplasty, and fractures distal to a hip joint. Specific Humeral indications according to AO classification may include Type A- Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact calotte, or Humeral Fractures according to Neer-Classification.

Source page: https://510kreport.com/device/K141347
Methodology: https://510kreport.com/methodology