# K080430: Stoma Bone Block Screw

- Pathway: 510(k) (Traditional)
- Applicant: Storz AM Mark GmbH
- Decided: Nov 21, 2008 after 276 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K51871: STOMA Bone Screws. Number could not be read Summary page 2.

## Most influential descendants
- K201210: The Micro Screw System, Micro Screw System Basic (2021), 1 descendant of its own
- K254286: Guided Bone Regeneration System (2026), 0 descendants of its own
- K103084: Neodent Graft Screw (2011), 0 descendants of its own

## Indications for use
STOMA bone block screws 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. STOMA bone block 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/K080430
Methodology: https://510kreport.com/methodology