# K073624: Modular Foot System

- Pathway: 510(k) (Traditional)
- Applicant: Orthohelix Surgical Designs, Inc.
- Decided: Mar 20, 2008 after 85 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: 6 generations back to K954385 (1996). 22 ancestors in all.
342 later devices descend from it; 5 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)
- K061808: Darco Locking Bone Plate System, Darco International, Inc. (2006) Summary page 1.
- K050868: Maxlock, Orthohelix Surgical Designs, Inc. (2005) Summary page 1.

## Most influential descendants
- K100618: Maxlock Extreme Extremity Plating System with Variable Angle Technology (2010), 339 descendants of its own
- 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

## Recalls of this device
- Mar 23, 2010 · Not classified · Z-1784-2010: On 3/9/10 it was discovered that the recalling firm packaged MFT-021-35-24 Screws from lot 0964092 as MFT-021-35-22 lot 0964081.

## Indications for use
The Modular Foot System is indicated for the fractures, fusions and osteotomies for small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.

Source page: https://510kreport.com/device/K073624
Methodology: https://510kreport.com/methodology