510(k) · Cleared
ClearedROSA ONE Spine application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtech S.A · OLO Orthopedic Stereotaxic Instrument
Cleared on Mar 22, 2019 as substantially equivalent to K151511 (Medtech S.A, 2016) after a 164-day review. Its family tree reaches back 7 generations to 2000. 10 later devices descend from it.
- Decided
- Mar 22, 2019
- Review
- 164 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K002053 (2000). 22 ancestors in all, the oldest K811452 (1981). 10 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 6 generations backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
- 5 generations backK043536 Navitrack System - S&N Image Free KneeOrthosoft, Inc. · 2005
- 4 generations backK060556 Brigit Surgical DeviceZimmer, Inc. · 2006
- 3 generations backK092239 Rosa Surgical Device, Model Rosa 1.1Medtech S.A · 2009 · Recalled
- 2 generations backK101791 Rosa Surgical DeviceMedtech S.A.S · 2010 · Recalled
- 1 generation backK151511 ROSA SpineMedtech S.A · 2016 · Recalled
- This deviceK182848 ROSA ONE Spine applicationMedtech S.A · 2019
- Descendant · cites it directly · 7 of its ownK221028 SURGIVISIO DeviceEcential Robotics · 2022
- Descendant · 2 generations on · 6 of its ownK231886 SURGIVISIO DeviceEcential Robotics · 2023
- Descendant · 3 generations on · 3 of its ownK242890 SPINEART Navigation Instrument SystemSpineart SA · 2025
- Descendant · 4 generations on · 2 of its ownK242933 SPINEART Navigation Instrument SystemSpineart SA · 2025
- Descendant · 3 generations on · 2 of its ownK233228 Spine Navigation and Robotic-Assistance DeviceEcential Robotics · 2024 · Recalled
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K221028SURGIVISIO DeviceEcential Robotics · 2022 · cites it directly7descendants
- K231886SURGIVISIO DeviceEcential Robotics · 2023 · 2 generations on6descendants
- K242890SPINEART Navigation Instrument SystemSpineart SA · 2025 · 3 generations on3descendants
- K242933SPINEART Navigation Instrument SystemSpineart SA · 2025 · 4 generations on2descendants
- K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics · 2024 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K002053 | Navitrak System-Optical Option, Model 900.004 | Orthosoft, Inc. | 2000 | — |
| −6 | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120 | Orthosoft, Inc. | 2002 | — |
| −5 | K043536 | Navitrack System - S&N Image Free Knee | Orthosoft, Inc. | 2005 | — |
| −4 | K060556 | Brigit Surgical Device | Zimmer, Inc. | 2006 | — |
| −3 | K092239 | Rosa Surgical Device, Model Rosa 1.1 | Medtech S.A | 2009 | 9 |
| −2 | K101791 | Rosa Surgical Device | Medtech S.A.S | 2010 | 12 |
| −1 | K151511 | ROSA Spine | Medtech S.A | 2016 | 3 |
| 0 (this device) | K182848 | ROSA ONE Spine application | Medtech S.A | 2019 | — |
| +1 | K221028 | SURGIVISIO Device | Ecential Robotics | 2022 | — |
| +2 | K231886 | SURGIVISIO Device | Ecential Robotics | 2023 | — |
| +3 | K242890 | SPINEART Navigation Instrument System | Spineart SA | 2025 | — |
| +4 | K242933 | SPINEART Navigation Instrument System | Spineart SA | 2025 | — |
| +3 | K233228 | Spine Navigation and Robotic-Assistance Device | Ecential Robotics | 2024 | 1 |
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 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | K151511 | ROSA SpineSummary page 4…Orthopaedic Regulatory Class: II Product Code: OLO (Spine) III PREDICATE DEVICES ROSA SPINE, manufactured by Medtech S.A., K151511, cleared in January 4, 2016 Page 1 of 8. ===… | 2016 |
What descends from it? (10)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 19 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 6 of the 22 ancestors have a recall of any class.
- Of its descendants, K221028 (Ecential Robotics, 2022) has gone furthest, with 7 descendants of its own.
- 3 other devices also cite its predicate K151511.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by
surgeons to guide standard surgical instruments during spine surgeries.
Guidance is based on an intraoperative 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 intended for the
placement of pedicle screws in vertebrae with a posterior approach in the thoracolumbar region.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182848 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182848: ROSA ONE Spine application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182848
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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