# K100618: Maxlock Extreme Extremity Plating System with Variable Angle Technology

- Pathway: 510(k) (Special)
- Applicant: Orthohelix Surgical Designs, Inc.
- Decided: Apr 20, 2010 after 47 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: 7 generations back to K954385 (1996). 25 ancestors in all.
339 later devices descend from it; 8 cite it directly.
0 of 365 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 2.
- K090289: Clavicle Plating System, Orthohelix Surgical Designs, Inc. (2009) Summary page 2.
- K060613: Variax Locking Plate System, Howmedica Osteonics Corp. (2006) Summary page 2.

## Most influential descendants
- 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
- K121651: Ortholoc 3DI Midfoot/Flatfoot System (2012), 95 descendants of its own

## Indications for use
Variable Angle technology in MTP, TMT, MFT, MXL, DFX, and EDL plates are indicated for fractures, fusions and osteotomies for small bones in the hand, wrist, foot and ankle in both pediatric and adult patients. Variable Angle Technology in MXL and CLA plates are indicated for the fractures, fusions, and osteotomnies of the clavicle and small bones in the hand, wrist, foot and ankle.

Source page: https://510kreport.com/device/K100618
Methodology: https://510kreport.com/methodology