# K972322: Lorenz 1.5 MM Neuro Pack/Lorenz 2.0 FT Plates

- Pathway: 510(k) (Traditional)
- Applicant: Walter Lorenz Surgical, Inc.
- Decided: Aug 18, 1997 after 59 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
15 later devices descend from it; 3 cite it directly.
0 of 16 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 no predicate by number.

## 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

## Recalls of this device
- Nov 25, 2020 · Class II · Z-0629-2021: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

## Indications for use
Rigid fixation of cranio, facial and neurological bone.

Source page: https://510kreport.com/device/K972322
Methodology: https://510kreport.com/methodology