# K063729: Disposable Pedicle Screw Probe, Model 3603-00

- Pathway: 510(k) (Traditional)
- Applicant: Technomed Europe
- Decided: Aug 21, 2007 after 249 days
- Product code: GXZ (Electrode, Needle)
- Device class: 2
- Regulation: 21 CFR 882.1350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K923056 (1992). 7 ancestors in all.
19 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062996: Disposable Monopolar and Bipolar Stimulator Probes, Axon Systems, Inc. (2007). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K103128: Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip Pedicle Screw Stimulator Probe, (2011), 17 descendants of its own
- K111597: Disposable Stimulating Electrode (2011), 10 descendants of its own
- K112709: Stimulation/Dissection Instruments (2012), 9 descendants of its own
- K132373: Biomet Access System (2014), 5 descendants of its own
- K073229: Nerve Monitoring Cable (2008), 5 descendants of its own

## Indications for use
The disposable pedicle screw probe is used to locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery.

Source page: https://510kreport.com/device/K063729
Methodology: https://510kreport.com/methodology