# K102130: Tenzing System

- Pathway: 510(k) (Special)
- Applicant: Mazor Surgical Technologies, Ltd.
- Decided: Aug 26, 2010 after 28 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: 8 generations back to K911783 (1994). 31 ancestors in all.
31 later devices descend from it; 2 cite it directly.
1 of 63 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073467: Spineassist System, Mazor Surgical Technologies, Ltd. (2008) Summary page 1.
- K081672: C-Insight, Mazor Surgical Technologies, Ltd. (2008) Summary page 1.

## Most influential descendants
- 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
- K152041: Renaissance X System (2015), 20 descendants of its own

## Indications for use
The TenZing System is a combination of the SpineAssist System and C-InSight System, allowing the C-InSight application to run on the SpineAssist Workstation: The SpineAssistTM System is indicated for precise positioning of surgical instruments or implants during general spinal surgery. The SpineAssistTM System may be used in either open or percutaneous procedures. The C-InSight software provides a processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects, particularly for orthopedic applications.

Source page: https://510kreport.com/device/K102130
Methodology: https://510kreport.com/methodology