# K073467: Spineassist System

- Pathway: 510(k) (Traditional)
- Applicant: Mazor Surgical Technologies, Ltd.
- Decided: May 23, 2008 after 165 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K911783 (1994). 22 ancestors in all.
32 later devices descend from it; 1 cites it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033413: Spineassist Device, Mazor Surgical Technologies, Ltd. (2004) Summary page 2.
- K051676: Spineassist Device with Additional Accessories, Mazor Surgical Technologies, Ltd. (2005) Summary page 2.
- K063607: Spineassist System, Mazor Surgical Technologies, Ltd. (2007) Summary page 2.
- K954276: Stealthstation, Surgical Navigation Technologies, Inc. (1996) Summary page 2.
- K050438: Stealthstation System Update, Medtronic Surgical Navigation Technologies (2005) Summary page 2.

## Most influential descendants
- K102130: Tenzing System (2010), 31 descendants of its own
- K110911: Renaissance System (2011), 24 descendants of its own
- K113228: Renaissance System (2011), 23 descendants of its own
- K140167: Renaissance X System (2014), 21 descendants of its own
- K120812: Renaissance (2012), 21 descendants of its own

## Indications for use
The SpineAssistTM System is indicated for precise positioning of surgical instruments or implants (pedicle screws, plates and etc.) during general spinal surgery. The SpineAssistTM System may be used in either open or percutaneous procedures.

Source page: https://510kreport.com/device/K073467
Methodology: https://510kreport.com/methodology