# K004027: Stryker Remote Surgical Planning System

- Pathway: 510(k) (Special)
- Applicant: Stryker Instruments
- Decided: Jan 24, 2001 after 28 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Sep 8, 2006 · Not classified · Z-0005-2007: A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire.
- Sep 8, 2006 · Not classified · Z-0006-2007: A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire.
- Sep 8, 2006 · Not classified · Z-0007-2007: A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire.
- Sep 8, 2006 · Not classified · Z-0008-2007: A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire.

Source page: https://510kreport.com/device/K004027
Methodology: https://510kreport.com/methodology