# K150655: OIC Intramedullary Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Orthopaedic Implant Company
- Decided: Jul 9, 2015 after 118 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: 3 generations back to K013468 (2001). 11 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043431: GAMMA3 Nail System, Howmedica Osteonics Corp. (2005) Summary page 4.
- K101438: T2 Greater Trochanter Nail, Howmedica Osteonics Corp. (2010) Summary page 4.
- K112059: T2 Femoral Nail Model 1825-Xxxxcp, 1828-Xxxxcp, Stryker (2011) Summary page 4.
- K003018: Titan Tibial Nail, Howmedica Osteonics Corp. (2000) Summary page 4.

## Most influential descendants
- K181184: OIC Intramedullary Nail System (2018), 1 descendant of its own
- K223761: OIC Intramedullary Screw System (2023), 0 descendants of its own

## Indications for use
The OIC Intramedullary Nail System is intended for surgical management of femoral and tibial fractures including open and closed fractures, pseudarthrosis and correction osteotomy, pathologic fractures, impending pathologic fractures, tumor resections, nonunions and malunions. The hip nails may be used for basilar neck, subtrochanteric and intertrochanteric fractures. The femoral nails may be used for fractures of the femur below the hip joint including ipsilateral femur fractures, fractures proximal to a total knee arthroplasty and supracondylar fractures, including those with intra-articular extension.

Source page: https://510kreport.com/device/K150655
Methodology: https://510kreport.com/methodology