# K101791: Rosa Surgical Device

- Pathway: 510(k) (Traditional)
- Applicant: Medtech S.A.S
- Decided: Sep 23, 2010 after 87 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K002053 (2000). 19 ancestors in all.
126 later devices descend from it; 4 cite it directly.
5 of 146 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092239: Rosa Surgical Device, Model Rosa 1.1, Medtech S.A (2009) Summary page 1.
- K001801: Steathstation Treatment Guidance Platform, Medtronic Surgical Navigation (2000) Summary page 1.
- K023651: Vectorvision Cranial/Ent, Brainlab AG (2004) Summary page 1.
- K991081: Frameless Neuromate, Integrated Surgical Systems, Inc. (1999) Summary page 1.

## Most influential descendants
- K151511: ROSA Spine (2016), 109 descendants of its own
- K171651: Excelsius GPS (2017), 69 descendants of its own
- K191100: ExcelsiusGPS Spine 1.1 Interbody Module (2019), 42 descendants of its own
- K182964: ROSA Knee System (2019), 29 descendants of its own
- K222270: HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments (2022), 23 descendants of its own

## Recalls of this device
- May 8, 2018 · Class II · Z-2108-2018: Replacement of units lacking an updated device approval.
- May 27, 2016 · Class II · Z-0105-2018: Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device.
- Apr 8, 2016 · Class II · Z-0115-2018: Potential for software to change the final tool orientation for the command position without command.
- Jan 20, 2016 · Class II · Z-3117-2017: Complaints were received reporting the system would freeze/shut down while in Fulgurate mode.
- Nov 6, 2014 · Class II · Z-0160-2018: Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended).
- Sep 5, 2014 · Class II · Z-0184-2018: The software issue described was corrected in the modification to the MXTTOUT controller parameter settings.
- Jun 4, 2014 · Class II · Z-0161-2018: Software corrections reactivating the cooperative endoscopy mode.
- Feb 14, 2014 · Class II · Z-0102-2018: An undetected shift between the information displayed in the navigation software and the actual patient anatomy
- Dec 18, 2013 · Class II · Z-0096-2018: Possible break in the connector of the Force Sensor.
- Feb 10, 2013 · Class II · Z-0178-2018: Issue with optional neuro-endoscopy module detected under specific conditions during internal testing.
- Feb 5, 2013 · Class II · Z-0099-2018: Observed instability of the device.
- Apr 19, 2012 · Class II · Z-0100-2018: Potential failure of the optical distance sensor due to cable disconnection.

## Indications for use
ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fidlucial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.

Source page: https://510kreport.com/device/K101791
Methodology: https://510kreport.com/methodology