# K911936: Osteomed SBF System (SBF)

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed Corp.
- Decided: Aug 21, 1991 after 112 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.
22 later devices descend from it; 4 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K090522: Osteomed Hand Plate and Screw Fixation System (2009), 15 descendants of its own
- K132769: Acumed Hand Plating System (2014), 7 descendants of its own
- K141383: Acumed Hand Fracture System (2014), 6 descendants of its own
- K161894: SurgTech Trauma System (2017), 3 descendants of its own
- K242939: ARTFX Trauma Bone Plate and Screw System (2024), 2 descendants of its own

Source page: https://510kreport.com/device/K911936
Methodology: https://510kreport.com/methodology