# K201210: The Micro Screw System, Micro Screw System Basic

- Pathway: 510(k) (Traditional)
- Applicant: Hager& Meisinger GmbH
- Decided: Oct 8, 2021 after 521 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: 1 generation back to K080430 (2008). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080430: Stoma Bone Block Screw, Storz AM Mark GmbH (2008) Summary page 4.

## Most influential descendants
- K254286: Guided Bone Regeneration System (2026), 0 descendants of its own

## Indications for use
The Micro Screw System, Micro Screw System Basic are developed and manufactured to be used as non-active bone surgery implants for the treatment of bone fractures, especially for the fixation of transplanted bone blocks during the augmentation process in the oral cavity and maxillomandibular surgical field. Note: Micro Screws are not intended to remain in the body permanently. After they have fulfilled their supportive function such as is the case after healing of a transplant, or healing of a fracture, for example, they need to be removed completely.

Source page: https://510kreport.com/device/K201210
Methodology: https://510kreport.com/methodology