# K211112: OIC External Fixation System

- Pathway: 510(k) (Special)
- Applicant: Orthopaedic Implant Company
- Decided: May 5, 2021 after 21 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- 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: 1 generation back to K061493 (2006). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183682: OIC External Fixation System, Orthopaedic Implant Company (2019) Summary page 4.
- K061493: Apex Pins, Stryker Howmedica Osteonics (2006) Summary page 4.

## Most influential descendants
- K242452: Monkey Bars Pin to Bar External Fixation System (2024), 0 descendants of its own

## Indications for use
The OIC External Fixation system is intended to be used in adult and pediatric patients for provisional fixation of open and/or unstable fractures in the lower and upper extremities and pelvis. It may also be used for temporary fixation of peri-articular or intra-articular fractures. Additionally, the device can be used on fractures where soft tissue injury or an infected fracture site may preclude the use of other fracture fixation treatments.

Source page: https://510kreport.com/device/K211112
Methodology: https://510kreport.com/methodology