# K102282: The Varia Fibula Locked Plating System Line Extension Addition of Straight Plates

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics
- Decided: Dec 7, 2010 after 117 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: 2 generations back to K000684 (2000). 4 ancestors in all.
77 later devices descend from it; 2 cite it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081284: Variax Distal Fibula Plate, Howmedica Osteonics Corp. (2008) Summary page 1.
- K001945: Synthes (Usa) Medial Distal Tibia Plates, Synthes (Usa) (2000) Summary page 1.
- K011335: Synths One-Third Tubular DCL Plate, Synthes (Usa) (2001)

## Most influential descendants
- 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
- K132502: Variax 2 System (2013), 21 descendants of its own

## Indications for use
The VariAx Fibula Straight Plates are intended for use in internal fixation of the distal fibula.

Source page: https://510kreport.com/device/K102282
Methodology: https://510kreport.com/methodology