# K191412: VariAx 2 System, VariAx 2 Mini Fragment System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker GmbH
- Decided: Aug 23, 2019 after 87 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: 14 generations back to K792022 (1979). 137 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 148 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132886: Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System, Smith & Nephew, Inc. (2014) Summary page 6.
- K063049: Synthes (Usa) Modular Mini Fragment LCP System, Synthes (Usa) (2006) Summary page 6.
- K180500: VariAx 2 System, Stryker GmbH (2018) Summary page 7.

## Most influential descendants
- K212581: VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System (2022), 4 descendants of its own
- K233919: VariAx 2 Distal Radius System (2024), 2 descendants of its own
- K220937: Arthrex Mini Fragment System (2022), 2 descendants of its own
- K242554: Arthrex VAL and VAL KreuLock™ Compression Screw System (2024), 1 descendant of its own
- K242343: BPS Wrist Fracture System (2024), 1 descendant of its own

## Indications for use
The VariAx 2 Mini Fragment System is indicated for fracture fixation, reconstruction, replantation, stabilization, reduction, fusions, osteotomies, mal-unions, and non-unions of small bones and small bone fragments including normal and osteopenic bones in adult and adolescent (12 – 21 years) patients. The system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones. The VariAx 2 System is indicated for adult and pediatric patients, where the implant would not cross open growth plates, for the treatment of normal or osteopenic bone for the following conditions or procedures: • Fracture fixation, including single, segmental, and comminuted fractures • Revision, including nonunion and malunion • Intra- and extra-articular fractures • Compression fracture • Displaced fracture • Reconstruction • Replantation • Arthrodesis • Osteotomy

Source page: https://510kreport.com/device/K191412
Methodology: https://510kreport.com/methodology