# K051676: Spineassist Device with Additional Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Mazor Surgical Technologies, Ltd.
- Decided: Sep 8, 2005 after 77 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: 5 generations back to K911783 (1994). 18 ancestors in all.
34 later devices descend from it; 2 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)
- K033413: Spineassist Device, Mazor Surgical Technologies, Ltd. (2004) Summary page 1.

## Most influential descendants
- 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
- K113228: Renaissance System (2011), 23 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. The Hover-T Bridge accessory used in conjunction with the SpineAssist device for minimally invasive surgical procedures, is intended for use for lumbar spinal fusion stabilization surgery.

Source page: https://510kreport.com/device/K051676
Methodology: https://510kreport.com/methodology