# K060613: Variax Locking Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Apr 21, 2006 after 45 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- 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
No predicates in its family tree.
341 later devices descend from it; 4 cite it directly.
0 of 342 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Numelock II System: named in the summary without a submission number
- (no number) Stryker Locked Plating System: named in the summary without a submission number
- (no number) Stryker Plating System: named in the summary without a submission number

## Most influential descendants
- K100618: Maxlock Extreme Extremity Plating System with Variable Angle Technology (2010), 339 descendants of its own
- K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System (2010), 228 descendants of its own
- K102156: Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws (2010), 119 descendants of its own
- K112583: Synthes Cortical Screws (2011), 118 descendants of its own
- K113014: Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws (2012), 97 descendants of its own

## Indications for use
The VariAx Locking Plate System is intended for use in the temporary stabilization of long bone fractures, including but not limited to: * Proximal and distal fractures including joint fractures of the humerus, tibia and other long bones * Metaphyseal, supracondylar, peri-articular, intra-articular, intra-articular condylar fractures * Diaphyseal fractures * Ankle fractures * Simple, comminuted and depression fractures * Non-unions and malunions * Osteotomies and bone reconstruction * Fractures in normal or osteoporotic bone

Source page: https://510kreport.com/device/K060613
Methodology: https://510kreport.com/methodology