# K101962: Mini Maxlock Extreme Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Orthohelix Surgical Designs, Inc.
- Decided: Sep 27, 2010 after 76 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K954385 (1996). 27 ancestors in all.
85 later devices descend from it; 7 cite it directly.
0 of 113 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063049: Synthes (Usa) Modular Mini Fragment LCP System, Synthes (Usa) (2006) Summary page 1.
- K050462: Sbi Hand Fixation System (TM), Small Bone Innovations, LLC (2005) Summary page 1.
- K083364: 2.5 MM Multidirectional Threaded Pegs, Models 131211110-131211130, 1.5 MM Locking Screws, Models 131220408-131220424, DePuy Orthopaedics, Inc. (2008) Summary page 1.
- K073624: Modular Foot System, Orthohelix Surgical Designs, Inc. (2008) Summary page 1.

## Most influential descendants
- K111041: Mini Variable System (2011), 77 descendants of its own
- 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

## Recalls of this device
- Jul 6, 2011 · Not classified · Z-3081-2011: The surgical tray does not meet our Instruction for Use (IFU) for dry time requirement.

## Indications for use
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.

Source page: https://510kreport.com/device/K101962
Methodology: https://510kreport.com/methodology