# K053472: Hoffmann II Mri External Fixation System

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jan 11, 2006 after 28 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.
31 later devices descend from it; 6 cite it directly.
0 of 32 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 MRI External Fixation System: named in the summary without a submission number
- (no number) Hoffmann II 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
- K091258: Extrafix External Fixation System (2009), 11 descendants of its own
- K111155: Xtrafix External Fixation System (2011), 9 descendants of its own
- K113383: Xtrafix External Fixation System (2012), 8 descendants of its own
- K122284: Hoffmann 3 (2012), 6 descendants of its own

## Indications for use
The Hoffmann® II MRI components are external fixation frame components for use with the components of the H1offinann® External Fixation System, I loffmann® I External Fixation System, Monotube® TRIAX TM External Fixation System and 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 rodding or casting.

Source page: https://510kreport.com/device/K053472
Methodology: https://510kreport.com/methodology