# K980512: Lorenz Reconstruction System with Modular Screw

- Pathway: 510(k) (Traditional)
- Applicant: Walter Lorenz Surgical, Inc.
- Decided: May 11, 1998 after 90 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
No predicates in its family tree.
18 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes Maxillofacial's Mandibular Modular Fixation System: named in the summary without a submission number
- (no number) Leibinger's Locking Screw Mandibular Reconstruction Plating System: named in the summary without a submission number

## Most influential descendants
- K063052: Lorenz Titanium Fracture / Reconstruction Devices and Pre-Bent Plates (2007), 16 descendants of its own
- K081067: Fracture/Reconstruction System (Traumaone) (2008), 14 descendants of its own
- 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

## Indications for use
The Lorenz Reconstruction System with Modular Screw is intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.

Source page: https://510kreport.com/device/K980512
Methodology: https://510kreport.com/methodology