# K081284: Variax Distal Fibula Plate

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jul 18, 2008 after 73 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.
100 later devices descend from it; 8 cite it directly.
0 of 101 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) Stryker® Foot: named in the summary without a submission number
- (no number) Profyle®: named in the summary without a submission number
- (no number) Universal Distal Radius System: named in the summary without a submission number
- (no number) Synthes® Small Fragment Locking Compression Plate (LCP) System: named in the summary without a submission number

## Most influential descendants
- K102282: The Varia Fibula Locked Plating System Line Extension Addition of Straight Plates (2010), 77 descendants of its own
- K123000: Integra Total Foot Systems (2012), 54 descendants of its own
- K132594: Crosscheck Plating System (2013), 23 descendants of its own
- K152974: ORTHOLOC® 3Di Foot Plating Reconstruction System (2015), 22 descendants of its own
- K163293: Colink™ Plating System (2017), 21 descendants of its own

## Indications for use
The VariAxTM Distal Lateral Fibula Plate is intended for use in internal fixation of the distal fibula.

Source page: https://510kreport.com/device/K081284
Methodology: https://510kreport.com/methodology