# K111041: Mini Variable System

- Pathway: 510(k) (Special)
- Applicant: Orthohelix Surgical Designs, Inc.
- Decided: Jun 6, 2011 after 53 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: 9 generations back to K954385 (1996). 33 ancestors in all.
77 later devices descend from it; 2 cite it directly.
0 of 111 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101962: Mini Maxlock Extreme Plating System, Orthohelix Surgical Designs, Inc. (2010) Summary page 1.
- K102156: Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws, Orthohelix Surgical Designs, Inc. (2010) Summary page 1.
- K100618: Maxlock Extreme Extremity Plating System with Variable Angle Technology, Orthohelix Surgical Designs, Inc. (2010) Summary page 1.
- (no number) Synthes 2.4mm/2.7mm Variable Angle (VA)-LCP Forefoot/Midfoot System: named in the summary without a submission number

## Most influential descendants
- K120157: Mini Maxlock Extreme Plating System (2012), 64 descendants of its own
- K121437: Mini Maxlock Extreme Plating System (2012), 38 descendants of its own
- K140397: Paralock Plating System / Tuffnek Screw (2014), 31 descendants of its own
- K172300: CoLink View Plating System (2017), 16 descendants of its own
- K181113: CoLink™ Afx Plating System (2018), 14 descendants of its own

## Indications for use
The Mini Variable System, when used with the Mini MaxLock Extreme® Plating System, is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments. The Mini Variable System, when used with the MaxLock Extreme® Distal Radius Plates and Screws, is intended for fractures and osteotomies of the distal radius in adult patients.

Source page: https://510kreport.com/device/K111041
Methodology: https://510kreport.com/methodology