# K051871: Stoma Bone Screw

- Pathway: 510(k) (Traditional)
- Applicant: Storz AM Mark GmbH
- Decided: Oct 27, 2005 after 108 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: 3 generations back to K820944 (1982). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961418: Osteomed MSS, Osteomed Corp. (1996) Summary page 2.
- K980760: KLS-Martin MMF Screw, KLS-Martin L.P. (1999) Summary page 2.
- K021850: Synthes (Usa) 1.3 MM Craniofacial Screws, Synthes (Usa) (2002) Summary page 2.

## Most influential descendants
- K132212: Dental Bone Screws; Dental Bone Screws, Continuing; Screw System TX; Screw System TX Professional (2014), 0 descendants of its own

## Indications for use
STOMA Bone 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 and / or in combination with bone plates and bone meshes in the oral cavity and maxillomandibular surgical field.

Source page: https://510kreport.com/device/K051871
Methodology: https://510kreport.com/methodology