# K223761: OIC Intramedullary Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Orthopaedic Implant Company
- Decided: Feb 13, 2023 after 60 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K970097 (1997). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183603: INnate Cannulated Screw System, Exsomed Corporation (2019) Summary page 4.
- K050636: Synthes 3.0MM Headless Compression Screws, Synthes (Usa) (2005) Summary page 4.
- K113123: Oic Cannulated Screw System, Oic Sliding Hip Screw (SHS) System, The Orthopaedic Implant Company (2012) Summary page 4.
- K181184: OIC Intramedullary Nail System, The Orthopaedic Implant Company (2018) Summary page 4.

## Indications for use
The OIC Intramedullary Screw System is indicated for the fixation of intra-articular and extra-articular fractures, malunions, non-unions or osteotomies of small bones and small bone fragments, as well as arthrodesis of small joints. The device is intended for use in adults.

Source page: https://510kreport.com/device/K223761
Methodology: https://510kreport.com/methodology