# K081067: Fracture/Reconstruction System (Traumaone)

- Pathway: 510(k) (Special)
- Applicant: Biomet Microfixation, Inc.
- Decided: May 9, 2008 after 24 days
- Product code: JEY (Plate, Bone)
- 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: 1 generation back to K980512 (1998). 2 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001238: Lorenz Titanium Fracture / Reconstruction Plating System, Walter Lorenz Surgical, Inc. (2000) Summary page 1.
- K980512: Lorenz Reconstruction System with Modular Screw, Walter Lorenz Surgical, Inc. (1998) Summary page 1.

## Most influential descendants
- K102641: Mini and  Micro Fragments Reconstruction System-Neoface (2010), 12 descendants of its own
- K142419: Mini and Micro Fragments Reconstruction System-NEOFIX (2014), 8 descendants of its own
- K182718: Mini and Micro Fragments Reconstruction System – GMReis (2019), 4 descendants of its own
- K242939: ARTFX Trauma Bone Plate and Screw System (2024), 2 descendants of its own
- K242596: Versalock Mini and Micro Plating System (2024), 2 descendants of its own

## Indications for use
Intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.

Source page: https://510kreport.com/device/K081067
Methodology: https://510kreport.com/methodology