# K132212: Dental Bone Screws; Dental Bone Screws, Continuing; Screw System TX; Screw System TX Professional

- Pathway: 510(k) (Traditional)
- Applicant: Hager& Meisinger GmbH
- Decided: Feb 14, 2014 after 213 days
- Product code: DZL (Screw, Fixation, Intraosseous)
- Device class: 2
- Regulation: 21 CFR 872.4880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K820944 (1982). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051871: Stoma Bone Screw, Storz AM Mark GmbH (2005) Summary page 1.
- K041887: Synthes (Usa) 1.0/1.22 MM Craniofacial Screws, Synthes (Usa) (2004) Summary page 1.

## Indications for use
The Meisinger Dental Bone Screws are intended for fixation of bone segments e.g. for horizontal or vertical augmentative grafts. Depending an indication the user choose the matching screw, prepares the pit hole and inserts the screw. The screws are intended for single use only.

Source page: https://510kreport.com/device/K132212
Methodology: https://510kreport.com/methodology