# K053038: Hoffmann II Compact Mri External Fixation System

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Nov 22, 2005 after 26 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
No predicates in its family tree.
16 later devices descend from it; 3 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)
- None. The FDA summary names its predicate without a number.
- (no number) Hoffmann® II Compact External Fixation System: named in the summary without a submission number

## Most influential descendants
- K111786: Hoffmann 3 Modular External Fixation System (2012), 13 descendants of its own
- 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

## Indications for use
The Hoffmann ® II Compact TM MRI components are intended to be used with the Half Pins or Transfixing Pins of the Hoffmann® External Fixation System and the components of the Hoffmann® II External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting, and other means of internal fixation.

Source page: https://510kreport.com/device/K053038
Methodology: https://510kreport.com/methodology