# K170727: VariAx 2 Compression Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker GmbH
- Decided: Jun 22, 2017 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: 6 generations back to K981372 (1998). 14 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140565: Variax 2 Compression Plating System, Stryker Trauma AG (2014) Summary page 4.
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 4.

## Most influential descendants
- K211051: DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System) (2021), 1 descendant of its own
- K254054: VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System (2026), 0 descendants of its own

## Indications for use
The Stryker VariAx 2 Compression Plating System is indicated for internal fixation of fractures in the Radius, Ulna, Humerus, Clavicle, Distal tibia and Fibula, in patients with normal bone density and osteopenic bone, for the following indications: • osteotomies, mal-unions, and non-unions • single, segmental, and comminuted fractures

Source page: https://510kreport.com/device/K170727
Methodology: https://510kreport.com/methodology