# K243190: USTOMED Bone Fixation/Bone Augmentation Systems - PIN

- Pathway: 510(k) (Traditional)
- Applicant: Ustomed Instrumente Ulrich Storz GmbH & Co. KG
- Decided: Jun 27, 2025 after 270 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: 6 generations back to K952167 (1995). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201561: Membrane Screws and Membrane Tacks, Neoss Limited (2020) Summary page 5.

## Indications for use
USTOMED Bone Fixation/Bone Augmentation Systems – PIN is intended for fastening membranes during bone regenerative treatment.

Source page: https://510kreport.com/device/K243190
Methodology: https://510kreport.com/methodology