# K032442: KLS-Martin Mandibular/Reconstruction System II

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: Oct 29, 2003 after 82 days
- Product code: MQN (External Mandibular Fixator And/Or Distractor)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K954385 (1996). 11 ancestors in all.
435 later devices descend from it; 7 cite it directly.
0 of 447 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961421: Synthes 2.4 MM Universal Locking Plate System, Synthes (Usa) (1996) Summary page 1.
- K974555: Synthes 2.0 MM Locking Plate System (2.0 LPS), Synthes (Usa) (1998) Summary page 1.
- K950045: KLS-Martin Mandibular Fracture/Reconstruction System, Karl Leibinger GmbH U. Co. KG (1995) Summary page 1.
- K943347: KLS Mini Osteosynthesis System, Patton, Boggs & Blow (1994) Summary page 1.
- K030448: Osteomed 2.0 Locking Plates and Screws, Osteomed LP (2003) Summary page 2.
- K990667: KLS-Martin Temporary Condylar Implant, KLS-Martin L.P. (2001) Summary page 1.

## Most influential descendants
- K040598: KLS Martin Hand Plating System (2004), 360 descendants of its own
- K050868: Maxlock (2005), 343 descendants of its own
- 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

## Indications for use
The KLS Martin Mandibular / Reconstruction System I I is intended for use in the stabilization and fixation ,of mandibular fractures and mandibular reconstruction.

Source page: https://510kreport.com/device/K032442
Methodology: https://510kreport.com/methodology