# K033413: Spineassist Device

- Pathway: 510(k) (Traditional)
- Applicant: Mazor Surgical Technologies, Ltd.
- Decided: Jan 7, 2004 after 72 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: 4 generations back to K911783 (1994). 17 ancestors in all.
35 later devices descend from it; 3 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963256: Neuromate Stereotactic System, Integrated Surgical Systems, S.A. (1997) Summary page 2.
- K991081: Frameless Neuromate, Integrated Surgical Systems, Inc. (1999) Summary page 2.
- K010968: Vectorvision CT/Fluoro, Brainlab AG (2001) Summary page 2.
- K021306: Vectorvision CT-Free Knee, Brainlab AG (2002) Summary page 2.
- K981315: Navitrack, Orthosoft, Inc. (1998) Summary page 2.
- K031156: Navitrack System-Fluorospine, Model 900.005, Orthosoft, Inc. (2003) Summary page 2.

## Most influential descendants
- K051676: Spineassist Device with Additional Accessories (2005), 34 descendants of its own
- K063607: Spineassist System (2007), 33 descendants of its own
- K073467: Spineassist System (2008), 32 descendants of its own
- K102130: Tenzing System (2010), 31 descendants of its own
- K110911: Renaissance System (2011), 24 descendants of its own

## Indications for use
The SpineAssist is indicated for precise positioning of surgical instruments during spinal fusion stabilization surgery. The device enables pre-operative planning of the surgical procedure and subsequent spatial positioning and orientation of the surgical tool during intra-operative procedures.

Source page: https://510kreport.com/device/K033413
Methodology: https://510kreport.com/methodology