# K111786: Hoffmann 3 Modular External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: Jan 26, 2012 after 216 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 K051306 (2005). 3 ancestors in all.
13 later devices descend from it; 5 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051306: Hoffmann II Mri External Fixation System, Howmedica Osteonics Corp. (2005) Summary page 3.
- K053038: Hoffmann II Compact Mri External Fixation System, Howmedica Osteonics Corp. (2005) Summary page 3.
- K053472: Hoffmann II Mri External Fixation System, Howmedica Osteonics Corp. (2006) Summary page 3.

## Most influential descendants
- K122284: Hoffmann 3 (2012), 6 descendants of its own
- K113770: Orthofix Galaxy Fixation System (2012), 6 descendants of its own
- K142052: Orthofix Galaxy Unyco Diaphyseal Tibia Kit (2014), 2 descendants of its own
- K153233: Galaxy UNYCO System (2016), 1 descendant of its own
- K121252: Hoffmann 3 Modular External Fixation System (2012), 1 descendant of its own

## Indications for use
The Hoffmann 3 Modular External Fixation System components are external fixation frame components for use with the components of the Hoffmann 11 MRI and Hoffmann 11 Compact MRI External Fixation Systems, in conjunction with Apex Pins. It is intended to provide stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rods, casts or other means of internal fixation.

Source page: https://510kreport.com/device/K111786
Methodology: https://510kreport.com/methodology