# K171211: OIC External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Orthopaedic Implant Company
- Decided: Sep 27, 2017 after 155 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: 3 generations back to K803166 (1981). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110965: Renovis T 710 Large External Fixation System, Renovis Surgical Technologies, LLC (2011) Summary page 4.
- K072212: Jet-X Bar System Clamps, Bars and Posts-MR Safe, Smith & Nephew, Inc. (2008) Summary page 4.
- K952730: Hoffmann II External Fixation System, Howmedica Corp. (1995) Summary page 4.
- K061493: Apex Pins, Stryker Howmedica Osteonics (2006) Summary page 4.
- K031428: Synthes (Usa) Large External Fixation Clamps-MR Safe, Synthes (Usa) (2003) Summary page 4.

## 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/K171211
Methodology: https://510kreport.com/methodology