510(k) · Cleared
Recalled · Class II · 2017ROSA Spine
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 Jan 4, 2016 as substantially equivalent to K101791 (Medtech S.A.S, 2010) and 1 other predicate after a 214-day review. Its family tree reaches back 6 generations to 2000. 1 of the 131 devices in its family, counting itself, has a Class I recall. 109 later devices descend from it. It has been recalled 3 times.
- Decided
- Jan 4, 2016
- Review
- 214 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 6 generations to K002053 (2000). 21 ancestors in all, the oldest K811452 (1981). 109 later devices descend from it, 4 citing it directly. 1 of the 131 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 5 generations backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
- 4 generations backK043536 Navitrack System - S&N Image Free KneeOrthosoft, Inc. · 2005
- 3 generations backK060556 Brigit Surgical DeviceZimmer, Inc. · 2006
- 2 generations backK092239 Rosa Surgical Device, Model Rosa 1.1Medtech S.A · 2009 · Recalled
- 1 generation backK101791 Rosa Surgical DeviceMedtech S.A.S · 2010 · Recalled
- This deviceK151511 ROSA SpineMedtech S.A · 2016
- Descendant · cites it directly · 69 of its ownK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 42 of its ownK191100 ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019
- Descendant · cites it directly · 29 of its ownK182964 ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
- Descendant · 3 generations on · 23 of its ownK222270 HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable…Globus Medical, Inc. · 2022
- Descendant · 2 generations on · 10 of its ownK230202 TMINI™ Miniature Robotic SystemTHINK Surgical, Inc. · 2023 · Recalled
Showing 5 of 109 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub2 generations on · 2021
Most influential descendants
Showing 5 of 109 · See all- K171651Excelsius GPSGlobus Medical, Inc. · 2017 · cites it directly69descendants
- K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019 · 2 generations on42descendants
- K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019 · cites it directly29descendants
- K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc. · 2022 · 3 generations on23descendants
- K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc. · 2023 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K002053 | Navitrak System-Optical Option, Model 900.004 | Orthosoft, Inc. | 2000 | — |
| −5 | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120 | Orthosoft, Inc. | 2002 | — |
| −4 | K043536 | Navitrack System - S&N Image Free Knee | Orthosoft, Inc. | 2005 | — |
| −3 | K060556 | Brigit Surgical Device | Zimmer, Inc. | 2006 | — |
| −2 | K092239 | Rosa Surgical Device, Model Rosa 1.1 | Medtech S.A | 2009 | 9 |
| −1 | K101791 | Rosa Surgical Device | Medtech S.A.S | 2010 | 12 |
| 0 (this device) | K151511 | ROSA Spine | Medtech S.A | 2016 | — |
| +1 | K171651 | Excelsius GPS | Globus Medical, Inc. | 2017 | 1 |
| +2 | K191100 | ExcelsiusGPS Spine 1.1 Interbody Module | Globus Medical, Inc. | 2019 | — |
| +1 | K182964 | ROSA Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019 | — |
| +3 | K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer… | Globus Medical, Inc. | 2022 | — |
| +2 | K230202 | TMINI™ Miniature Robotic System | THINK Surgical, Inc. | 2023 | 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 |
|---|---|---|
| 2017 | 2 | 0 |
| 2019 | 7 | 0 |
| 2020 | 1 | 0 |
| 2021 | 6 | 1 |
| 2022 | 10 | 0 |
| 2023 | 16 | 0 |
| 2024 | 20 | 0 |
| 2025 | 24 | 0 |
| 2026 | 23 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K101791 | Rosa Surgical Device 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”. | 2010 |
| * | K133444 | Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation SystemSummary page 4…ROSA Surgical Device, manufactured by Medtech S.A., K101797, cleared September 23, 2010 StealthStation System, manufactured by Medtronic Navigation Inc., K133444, cleared July 25, 2014 Page 1 / 7 === Page 5… | 2014 |
What descends from it? (109)
See all 1094 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 1, 2017 | Class II | Z-0639-2018 | Software design | Robot arm being sent to the wrong position |
| Feb 27, 2017 | Class II | Z-1755-2017 | Component change control | Unapproved change made by the supplier. |
| Oct 29, 2015 | Class II | Z-0177-2018 | Software design | 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. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 2 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 5 of the 21 ancestors have a recall of any class.
- Of its descendants, K171651 (Globus Medical, Inc., 2017) has gone furthest, with 69 descendants of its own.
- 3 other devices also cite its predicate K101791.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 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
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/K151511 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151511: ROSA Spine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151511
Report an extraction error
Are you the manufacturer?
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