# K080667: Variax Distal Radius Torx Screws

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Mar 19, 2008 after 9 days
- Product code: HRS (Plate, Fixation, Bone)
- 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.
22 later devices descend from it; 1 cites it directly.
0 of 23 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 Leibinger Universal Distal Radius System: named in the summary without a submission number
- (no number) Stryker Foot System: named in the summary without a submission number

## Most influential descendants
- K132502: Variax 2 System (2013), 21 descendants of its own
- K140769: Variax 2 System (2014), 19 descendants of its own
- K173135: VariAx 2 System (2017), 13 descendants of its own
- K180500: VariAx 2 System (2018), 12 descendants of its own
- K191412: VariAx 2 System, VariAx 2 Mini Fragment System (2019), 10 descendants of its own

## Indications for use
Stryker® Leibinger Universal Distal Radius System is intended for use in internal fixation of the small bone fractures, primarily including distal radius fractures. Examples of these distal radius fractures include compression fractures, intra-articular and extra-articular fractures, displaced fractures and surgical reduction. This system can be used for palmar, dorsal, or orthogonal application.

Source page: https://510kreport.com/device/K080667
Methodology: https://510kreport.com/methodology