# K113228: Renaissance System

- Pathway: 510(k) (Special)
- Applicant: Mazor Robotics, Ltd.
- Decided: Dec 1, 2011 after 30 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: 10 generations back to K911783 (1994). 34 ancestors in all.
23 later devices descend from it; 2 cite it directly.
1 of 58 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110911: Renaissance System, Mazor Robotics, Ltd. (2011) Summary page 1.
- K050438: Stealthstation System Update, Medtronic Surgical Navigation Technologies (2005) Summary page 1.
- K022414: Stealthstation System Three Dimensional C-Arm Interface, Medtronic Surgical Navigation Technologies (2002) Summary page 1.

## Most influential descendants
- 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
- K163221: Mazor X (2017), 19 descendants of its own
- K180307: Mazor X (2018), 17 descendants of its own

## Indications for use
The Renaissance System is indicated for precise positioning of surgical instruments or implants during general spinal surgery. It may be used in either open or percutaneous procedures. Renaissance 3D imaging capabilities provide 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.

Source page: https://510kreport.com/device/K113228
Methodology: https://510kreport.com/methodology