# K151511: ROSA Spine

- Pathway: 510(k) (Traditional)
- Applicant: Medtech S.A
- Decided: Jan 4, 2016 after 214 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K002053 (2000). 21 ancestors in all.
109 later devices descend from it; 4 cite it directly.
1 of 131 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101791: Rosa Surgical Device, Medtech S.A.S (2010). Our reading of the summary gave K101797, FDA’s number for Sonicision Cordless Ultrasonic Dissection Device Model… (Covidien, Formerly Valleylab, A Division of Tyco). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “ROSA Surgical Device”. Summary page 6.
- K133444: Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System, Medtronic Navigation, Inc. (2014) Summary page 4.

## Most influential descendants
- 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
- K230202: TMINI™ Miniature Robotic System (2023), 10 descendants of its own

## Recalls of this device
- May 1, 2017 · Class II · Z-0639-2018: Robot arm being sent to the wrong position
- Feb 27, 2017 · Class II · Z-1755-2017: Unapproved change made by the supplier.
- Oct 29, 2015 · Class II · Z-0177-2018: A design change was initiated to update ROSA Spine 1.0.2 to version ROSA Spine 1.0.2.16 to resolve software bugs and improve usability and stability of the ROSA Spine device.

## Indications for use
The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed with three dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The device is indicated for the placement of pedicle screws in lumbar vertebrae with a posterior approach

Source page: https://510kreport.com/device/K151511
Methodology: https://510kreport.com/methodology