# K082649: Synthes 90 Degree Screwdriver

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Apr 30, 2009 after 230 days
- Product code: DZI (Drill, Bone, Powered)
- Device class: 2
- Regulation: 21 CFR 872.4120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes Electric Pen Drive System: named in the summary without a submission number

## Most influential descendants
- K150392: PROPEL device (2015), 1 descendant of its own
- K253655: Angled Screwdriver MED (M-SD090) (2026), 0 descendants of its own
- K172164: PROPEL Device (2018), 0 descendants of its own
- K150796: Dental Bone Cutting Instruments (2015), 0 descendants of its own

## Indications for use
The Synthes 90 0 Screwdriver is indicated for the manual and powered pre-drilling and insertion of bone fixation screws in oral/maxillofacial surgery.

Source page: https://510kreport.com/device/K082649
Methodology: https://510kreport.com/methodology