# K983535: The Titanium Miniplating System, the Titanium Microplating System, the Titanium Mediumplating System, Model #'S H12-1010

- Pathway: 510(k) (Traditional)
- Applicant: Hans Hermann GmbH
- Decided: Dec 29, 1998 after 81 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Hermann Titanium (Mini/Micro/Medium) plating systems are intended for maxillo-facial surgery. The various sizes are designed to accommodate osteosynthesis requirements in pediatric and adult patients. Medical Indications - Fractures in maxillo-facial bones

Source page: https://510kreport.com/device/K983535
Methodology: https://510kreport.com/methodology