# K112455: Aiming Blocks for Variax Distal Radius Plates

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics
- Decided: Sep 22, 2011 after 28 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: 4 generations back to K885250 (1989). 13 ancestors in all.
56 later devices descend from it; 3 cite it directly.
0 of 70 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 1.
- K100271: Vari AX Distal Radius Line Extensions of XXL Plates, Howmedica Osteonics Corp. (2010) Summary page 1.

## Most influential descendants
- 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
- K140769: Variax 2 System (2014), 19 descendants of its own
- K130116: Superior Lateral Variax Clavicle Plate (2013), 16 descendants of its own
- K123562: Flower Small and Medium Bone Implants (2013), 14 descendants of its own

## Indications for use
The VariAx®M 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 mat-unions. This system can be used for palmar, dorsal or orthogonal application.

Source page: https://510kreport.com/device/K112455
Methodology: https://510kreport.com/methodology