# K100271: Vari AX Distal Radius Line Extensions of XXL Plates

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: May 14, 2010 after 105 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
Longest line of descent: 3 generations back to K885250 (1989). 12 ancestors in all.
80 later devices descend from it; 4 cite it directly.
0 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040022: Stryker Leibinger Universal Distal Radius System, Stryker Leibinger (2004) Summary page 2.
- K070946: Synthes LCP Diaphyseal-Metaphyseal (Dia-Meta) Volar Distal Radius Plates, Synthes (Usa) (2007) Summary page 2.
- K040593: Periarticular Locking Plates and Screws, 2358, 2359 Series, Zimmer, Inc. (2004) Summary page 2.

## Most influential descendants
- K112455: Aiming Blocks for Variax Distal Radius Plates (2011), 56 descendants of its own
- K113760: Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks & Joystick (2012), 40 descendants of its own
- K132502: Variax 2 System (2013), 21 descendants of its own
- K133974: Variax Distal Radius Plating System (2014), 20 descendants of its own
- K131474: Arthrex Distal Radius Plate System (2013), 20 descendants of its own

## Indications for use
The indications for use of the Distal Radius System: The Stryker® XXL Volar Distal Radius Plates are intended for use for internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and mal-unions. This system can be used for palmar, dorsal or orthogonal application.

Source page: https://510kreport.com/device/K100271
Methodology: https://510kreport.com/methodology