# K113048: Maxlock Extreme System

- Pathway: 510(k) (Traditional)
- Applicant: Orthohelix Surgical Designs, Inc.
- Decided: Jan 30, 2012 after 110 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). 36 ancestors in all.
52 later devices descend from it; 4 cite it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090289: Clavicle Plating System, Orthohelix Surgical Designs, Inc. (2009) Summary page 2.
- K093900: Edgelock, Orthohelix Surgical Designs, Inc. (2010) Summary page 2.
- K100618: Maxlock Extreme Extremity Plating System with Variable Angle Technology, Orthohelix Surgical Designs, Inc. (2010) Summary page 2.
- K102156: Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws, Orthohelix Surgical Designs, Inc. (2010) Summary page 2.
- K092528: Biomet Forerunner Locking Plate System, Biomet Trauma (Aka Ebi, Lp) (2010) Summary page 2.
- K061400: Calcaneal Trauma System, Orthohelix Surgical Designs, Inc. (2006) Summary page 2.
- K061098: Ebi Optilock Periarticular Plating System, Ebi, L.P. (2006) Summary page 2.

## Cited in the summary but kept off the family tree
- K073962: MaxLock Extreme System. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K122005: Maxlock Extreme System (2012), 39 descendants of its own
- K123203: Maxlock Extreme System Model MXL (2012), 38 descendants of its own
- K132591: Maxlock Extreme System (2013), 32 descendants of its own
- K153379: AxSOS 3Ti (2016), 25 descendants of its own
- K162439: AxSOS 3 Ti; Stryker Plating System (2017), 24 descendants of its own

## Indications for use
The MaxLock Extreme System is indicated for the following: o The Universal Module is indicated for use in adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, humerus, ulna, radius, and bones in the hand, wrist, foot and ankle. o The Clavicle Module is indicated for fractures, fusions and osteotomies of the clavicle and bones in the hand, wrist, foot and ankle. o The Foot Module is indicated for fractures, fusions and osteotomies of bones in the hand, wrist, foot and ankle in pediatric and adult patients. o The Distal Radius Module is indicated for fractures and osteotomies of the distal radius in adult patients.

Source page: https://510kreport.com/device/K113048
Methodology: https://510kreport.com/methodology