# K000957: Hoffmann II External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: May 23, 2000 after 60 days
- Product code: LXT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite)
- 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K021933: Tempfix External Fixation System (2002), 2 descendants of its own
- K052918: Reprocessed External Fixation Devices (2006), 0 descendants of its own
- K043113: Tempfix External Fixation System, MR Safe (2005), 0 descendants of its own
- K022423: External Fixation Ring (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K000957
Methodology: https://510kreport.com/methodology