# K102156: Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws

- Pathway: 510(k) (Special)
- Applicant: Orthohelix Surgical Designs, Inc.
- Decided: Sep 30, 2010 after 62 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: 8 generations back to K954385 (1996). 28 ancestors in all.
119 later devices descend from it; 2 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)
- K073624: Modular Foot System, Orthohelix Surgical Designs, Inc. (2008) Summary page 1.
- K100618: Maxlock Extreme Extremity Plating System with Variable Angle Technology, Orthohelix Surgical Designs, Inc. (2010) Summary page 1.
- K002775: Distal Volar Radius Fracture Repair System, Hand Innovations, Inc. (2000) Summary page 1.
- K063049: Synthes (Usa) Modular Mini Fragment LCP System, Synthes (Usa) (2006) 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
- K113048: Maxlock Extreme System (2012), 52 descendants of its own
- K122005: Maxlock Extreme System (2012), 39 descendants of its own
- K123203: Maxlock Extreme System Model MXL (2012), 38 descendants of its own

## Recalls of this device
- Aug 22, 2011 · Not classified · Z-0421-2012: The firm discovered a testing protocol error, in both dynamic and static cantilever comparative testing, during the initial comparative testing.

## Indications for use
The MaxLock Extreme® Distal Radius Plates and Screws are indicated for fractures and osteotomies of the distal radius in adult patients.

Source page: https://510kreport.com/device/K102156
Methodology: https://510kreport.com/methodology