# K954717: Sodem High Speed System for Neurosurgery & Median Sternotomy

- Pathway: 510(k) (Traditional)
- Applicant: Sodem Diffusion SA
- Decided: Jan 22, 1997 after 467 days
- Product code: HBB (Motor, Drill, Pneumatic)
- Device class: 2
- Regulation: 21 CFR 882.4370
- 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 K831756 (1983). 2 ancestors in all.
1 later device descends from it; 1 cites 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)
- K922299: Zeppelin Motor Drill System, Von Zeppelin Chirurgische Instrumente GmbH (1992) Summary page 2.
- K831756: Anspach 65,000, The Anspach Effort, Inc. (1983) Summary page 2.
- (no number) Zimmer Ultra Power System: named in the summary without a submission number
- (no number) Midas Rex System: named in the summary without a submission number

## Most influential descendants
- K993851: Sodem Perforator Drive (1999), 0 descendants of its own

## Indications for use
The SODEM HIGH SPEED SYSTEM (with associated accessories/attachments) is intended for use for neurosurgery (spine and craniotomy) and median sternotomy.

Source page: https://510kreport.com/device/K954717
Methodology: https://510kreport.com/methodology