ROSA SURGICAL DEVICE— 510(k) K101791

Clearance details

Applicant

Medtech S.A.S

Product code

Code HAW

Device class

Class 2

Regulation

21 CFR 882.4560

Advisory panel

Neurology

Date received

2010-06-28

Decision date

2010-09-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Montpellier, FR

• K253856 — Geniant Cranial (Navigated Neurosurgical Positioning Robot)2026-09-10
• K261932 — Leksell® Vantage Stereotactic System2026-08-05
• K253663 — Zeta Navigation System2026-05-01
• K253379 — Stealth AXiS Cranial clinical application2026-03-26
• K231897 — NeuroAlign software2025-10-21

• K231103 — ROSA ONE Brain Application2023-07-20
• K214065 — ROSA ONE Brain application2022-05-04

Death

52

Injury

1,083

Malfunction

17,300

Total

18,435

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2108-2018 — ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 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 fiducial 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.Class II·Terminated·MEDTECH SAS·20180508
• Z-0105-2018 — ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be inappropriate.Class II·Terminated·Zimmer Biomet, Inc.·20160527
• Z-0115-2018 — ROSA Surgical Device 2.5.8Class II·Terminated·Zimmer Biomet, Inc.·20160408
• Z-3117-2017 — Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic Assistant Surgical Device, Model 2.5.8. The firm name on the foot switch label is Herga Electric Limited, Bury, St. Edmunds, Suffolk IP32 6NN. 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 fiducial 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 appropriateClass II·Terminated·Zimmer Biomet, Inc.·20160120
• Z-0160-2018 — ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.Class II·Terminated·Zimmer Biomet, Inc.·20141106
• Z-0184-2018 — ROSA Surgical Device 2.5.8 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 fiducial 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 appropriateClass II·Terminated·Zimmer Biomet, Inc.·20140905
• Z-0161-2018 — ROSA Surgical Device 2.5.8 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 fiducial 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.Class II·Terminated·Zimmer Biomet, Inc.·20140604
• Z-0102-2018 — ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guideClass II·Terminated·Zimmer Biomet, Inc.·20140214
• Z-0096-2018 — ROSA Surgical Device 2.5.8 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 fiducial 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 appropriateClass II·Terminated·Zimmer Biomet, Inc.·20131218
• Z-0178-2018 — ROSA Surgical Device 2.5.8Class II·Terminated·Zimmer Biomet, Inc.·20130210
• Z-0099-2018 — ROSA Surgical Device 2.5.8 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 fiducial 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.Class II·Terminated·Zimmer Biomet, Inc.·20130205
• Z-0100-2018 — ROSA Surgical Device 2.5.8 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 fiducial 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 appropriateClass II·Terminated·Zimmer Biomet, Inc.·20120419

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101791.