510(k) · Cleared
ClearedSURGIVISIO Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ecential Robotics · OLO Orthopedic Stereotaxic Instrument
Cleared on Jul 6, 2022 as substantially equivalent to K141941 (Stryker Corporate, 2014) and 1 other predicate after a 90-day review. Its family tree reaches back 8 generations to 2000. 7 later devices descend from it.
- Decided
- Jul 6, 2022
- Review
- 90 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K002053 (2000). 30 ancestors in all, the oldest K811452 (1981). 7 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 7 generations backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
- 6 generations backK043536 Navitrack System - S&N Image Free KneeOrthosoft, Inc. · 2005
- 5 generations backK060556 Brigit Surgical DeviceZimmer, Inc. · 2006
- 4 generations backK092239 Rosa Surgical Device, Model Rosa 1.1Medtech S.A · 2009 · Recalled
- 3 generations backK101791 Rosa Surgical DeviceMedtech S.A.S · 2010 · Recalled
- 2 generations backK151511 ROSA SpineMedtech S.A · 2016 · Recalled
- 1 generation backK182848 ROSA ONE Spine applicationMedtech S.A · 2019
- This deviceK221028 SURGIVISIO DeviceEcential Robotics · 2022
- Descendant · cites it directly · 6 of its ownK231886 SURGIVISIO DeviceEcential Robotics · 2023
- Descendant · 2 generations on · 3 of its ownK242890 SPINEART Navigation Instrument SystemSpineart SA · 2025
- Descendant · 3 generations on · 2 of its ownK242933 SPINEART Navigation Instrument SystemSpineart SA · 2025
- Descendant · 2 generations on · 2 of its ownK233228 Spine Navigation and Robotic-Assistance DeviceEcential Robotics · 2024 · Recalled
- Descendant · 3 generations on · 1 of its ownK261113 Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K231886SURGIVISIO DeviceEcential Robotics · 2023 · cites it directly6descendants
- K242890SPINEART Navigation Instrument SystemSpineart SA · 2025 · 2 generations on3descendants
- K242933SPINEART Navigation Instrument SystemSpineart SA · 2025 · 3 generations on2descendants
- K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics · 2024 · 2 generations on2descendants
- K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics · 2026 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K002053 | Navitrak System-Optical Option, Model 900.004 | Orthosoft, Inc. | 2000 | — |
| −7 | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120 | Orthosoft, Inc. | 2002 | — |
| −6 | K043536 | Navitrack System - S&N Image Free Knee | Orthosoft, Inc. | 2005 | — |
| −5 | K060556 | Brigit Surgical Device | Zimmer, Inc. | 2006 | — |
| −4 | K092239 | Rosa Surgical Device, Model Rosa 1.1 | Medtech S.A | 2009 | 9 |
| −3 | K101791 | Rosa Surgical Device | Medtech S.A.S | 2010 | 12 |
| −2 | K151511 | ROSA Spine | Medtech S.A | 2016 | 3 |
| −1 | K182848 | ROSA ONE Spine application | Medtech S.A | 2019 | — |
| 0 (this device) | K221028 | SURGIVISIO Device | Ecential Robotics | 2022 | — |
| +1 | K231886 | SURGIVISIO Device | Ecential Robotics | 2023 | — |
| +2 | K242890 | SPINEART Navigation Instrument System | Spineart SA | 2025 | — |
| +3 | K242933 | SPINEART Navigation Instrument System | Spineart SA | 2025 | — |
| +2 | K233228 | Spine Navigation and Robotic-Assistance Device | Ecential Robotics | 2024 | 1 |
| +3 | K261113 | Op.n™ Spine Navigation and Robotic Guidance | Ecential Robotics | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1987 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OLO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OLO device
- #1 K240662 Spine Guidance Software (version 5.0); Xia 3/…score 23.7 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K141941 | Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D 3.0-Upgreade, Spinemap 3D…Summary page 4…eotaxic Instrument Regulation Number: 21 CFR 882.4560 Regulatory class: II Primary product code: OLO Legally marketed device - K141941 Stryker SpineMap® 3D Navigation System to which equivalence is (available with SpineMask™ tracking device) by Stryke… | 2014 |
| * | K182848 | ROSA ONE Spine applicationSummary page 4…eibinger GmbH & Co for the free hand navigation feature of the SURGIVISIO Device [Primary], and - K182848 ROSA® ONE Spine application by Medtech S.A.(Zimmer Biomet) for the robotic guidance feature… | 2019 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231886 | SURGIVISIO Device | 2023 | 6 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- 10 of the 30 ancestors have a recall of any class.
- Of its descendants, K231886 (Ecential Robotics, 2023) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K141941.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · OLO
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLO
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OLO
3,306in 2025
MAUDE reports naming product code OLO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 11 | 126 | 0 | 4 |
| 2010 | 9 | 113 | 1 | 4 |
| 2011 | 11 | 138 | 1 | 10 |
| 2012 | 7 | 129 | 1 | 60 |
| 2013 | 7 | 137 | 0 | 36 |
| 2014 | 10 | 119 | 3 | 245 |
| 2015 | 10 | 176 | 2 | 466 |
| 2016 | 14 | 120 | 3 | 750 |
| 2017 | 33 | 91 | 2 | 1,076 |
| 2018 | 24 | 97 | 1 | 1,230 |
| 2019 | 35 | 95 | 1 | 1,585 |
| 2020 | 34 | 89 | 6 | 2,746 |
| 2021 | 28 | 91 | 0 | 1,696 |
| 2022 | 40 | 89 | 5 | 1,568 |
| 2023 | 45 | 90 | 7 (1) | 1,493 |
| 2024 | 44 | 90 | 4 | 2,353 |
| 2025 | 40 | 119 | 1 | 3,306 |
| 2026 | 42 | 109 | 6 | — |
What is it indicated for?
The SURGIVISIO Device is intended to be used during surgical procedures in which the physician would benefit from the visualization of 2D medical imaging and/or intraoperatively generated 3D medical imaging of anatomical structures or objects with high x-ray attenuation such as bony anatomy or metallic objects. Such procedures include procedures during which the spine, pelvis, or articulation structures are visualized The SURGIVISIO Device through its…
Read the full statement (236 words)
The SURGIVISIO Device is intended to be used during surgical procedures in which the physician would benefit from the visualization of 2D medical imaging and/or intraoperatively generated 3D medical imaging of anatomical structures or objects with high x-ray attenuation such as bony anatomy or metallic objects. Such procedures include procedures during which the spine, pelvis, or articulation structures are visualized
The SURGIVISIO Device through its freehand navigation feature is intended as an intraoperative guidance system to enable open or percutaneous computer-assisted surgery.
It is indicated for conditions of the spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical bony structure can be identified relative to the intraoperatively generated 3D image of the anatomy provided by the SURGIVISIO Device.
It is indicated to precisely position the Navigated Targeting Needle SPX1 during general spinal procedures with a posterior approach.
The SURGIVISIO Device through its robotic guidance feature is intended for the positioning of instrument holders or tool guides to be used by surgeons to guide the Spine CoBot instruments during general spinal surgery.
Guidance is based on an intra-operative plan developed with three-dimensional imaging software based on intra-operative 3D images provided by the SURGIVISIO Device.
It is indicated for positioning of surgical instruments in vertebrae with a posterior approach in the thoracolumbar region.
The SPXlInstrumentsSPX1 Instrument and Spine CoBot instruments are intended to be used with the SURGIVISIO Device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221028 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221028: SURGIVISIO Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221028
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026