# K121252: Hoffmann 3 Modular External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: Jul 25, 2012 after 91 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: 2 generations back to K051306 (2005). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111786: Hoffmann 3 Modular External Fixation System, Stryker Corp. (2012)

## Most influential descendants
- K182285: PK High Tibial Osteotomy Correction System (2019), 0 descendants 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 I1 MRI and Hoffmann I1Compact MRI External Fixation Systems, in conjunction with Apex Pins. It is intended to provide stabilization of open and/or unstable fractuires and where soft tissue injury precludes the use of other fracture treatments such as TM rods, casts or other means of internal fixation. The indications for use of external fixation devices include: *Bone fracture fixation *Osteotomy *Arthrodesis *Correction of deformity *Revision procedure where other treatments or devices have been unsuccessful *Bone reconstruction procedures

Source page: https://510kreport.com/device/K121252
Methodology: https://510kreport.com/methodology