# K050868: Maxlock

- Pathway: 510(k) (Traditional)
- Applicant: Orthohelix Surgical Designs, Inc.
- Decided: May 27, 2005 after 51 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: 5 generations back to K954385 (1996). 19 ancestors in all.
343 later devices descend from it; 1 cites it directly.
0 of 363 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920738: Ace 100 Degrees Tubular Plate, Ace Orthopedic Manufacturing Co. (1992) Summary page 1.
- K040598: KLS Martin Hand Plating System, KLS-Martin L.P. (2004) Summary page 1.

## Most influential descendants
- K073624: Modular Foot System (2008), 342 descendants of its own
- 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

## Indications for use
The MaxLock Small Bone System is indicated for the repair of osteotomies and fractures of: * Phalanges of the hands and feet. * Metacarpals and metatarsals. * Carpals and tarsal bones. * The wrist and ankle and, * Arthrodesis of the hands, wrists, foot and ankle.

Source page: https://510kreport.com/device/K050868
Methodology: https://510kreport.com/methodology