510(k) · Cleared
ClearedSPINEART Navigation Instrument System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spineart SA · OLO Orthopedic Stereotaxic Instrument
Cleared on Jul 29, 2026 as substantially equivalent to K210472 (Spineart, 2021) and 4 other predicates after a 107-day review. Its family tree reaches back 22 generations to 2004. 4 of the 728 devices in its family, counting itself, have a Class I recall.
- Decided
- Jul 29, 2026
- Review
- 107 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 22 generations to K040583 (2004). 727 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 4 of the 728 devices in this family, counting this one, have a Class I recall.
- Root · 22 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 18 generations between
- 3 generations backK241644 SPINEART Navigation Instrument SystemSpineart SA · 2024
- 2 generations backK242933 SPINEART Navigation Instrument SystemSpineart SA · 2025
- 1 generation backK254158 SPINEART Navigation Instrument SystemSpineart SA · 2026
- This deviceK261205 SPINEART Navigation Instrument SystemSpineart SA · 2026
Show all 22 generations
- Root · 22 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 21 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 20 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 19 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 18 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 17 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 16 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 15 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 14 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 13 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 12 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 11 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 10 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 9 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 8 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 7 generations backK143375 CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- 6 generations backK153203 Navigation InstrumentsGlobus Medical, Inc. · 2016
- 5 generations backK183630 SPINEART Navigation Instrument SystemSpineart SA · 2019
- 4 generations backK210472 SPINEART Navigation Instrument SystemSpineart · 2021
- 3 generations backK241644 SPINEART Navigation Instrument SystemSpineart SA · 2024
- 2 generations backK242933 SPINEART Navigation Instrument SystemSpineart SA · 2025
- 1 generation backK254158 SPINEART Navigation Instrument SystemSpineart SA · 2026
- This deviceK261205 SPINEART Navigation Instrument SystemSpineart SA · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −21 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −20 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −19 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −18 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −17 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −16 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −15 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −14 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −13 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −12 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −11 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −10 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −9 | K122862 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −8 | K141605 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| −7 | K143375 | CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −6 | K153203 | Navigation Instruments | Globus Medical, Inc. | 2016 | — |
| −5 | K183630 | SPINEART Navigation Instrument System | Spineart SA | 2019 | — |
| −4 | K210472 | SPINEART Navigation Instrument System | Spineart | 2021 | — |
| −3 | K241644 | SPINEART Navigation Instrument System | Spineart SA | 2024 | — |
| −2 | K242933 | SPINEART Navigation Instrument System | Spineart SA | 2025 | — |
| −1 | K254158 | SPINEART Navigation Instrument System | Spineart SA | 2026 | — |
| 0 (this device) | K261205 | SPINEART Navigation Instrument System | Spineart SA | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 2 | 0 |
| 1980 | 1 | 0 |
| 1981 | 2 | 0 |
| 1984 | 2 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 3 | 0 |
| 1988 | 2 | 0 |
| 1989 | 5 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 4 | 0 |
| 1994 | 7 | 0 |
| 1995 | 15 | 0 |
| 1996 | 17 | 0 |
| 1997 | 13 | 0 |
| 1998 | 19 | 0 |
| 1999 | 21 | 0 |
| 2000 | 30 | 0 |
| 2001 | 42 | 0 |
| 2002 | 34 | 0 |
| 2003 | 41 | 0 |
| 2004 | 65 | 0 |
| 2005 | 50 | 0 |
| 2006 | 36 | 0 |
| 2007 | 31 | 1 |
| 2008 | 62 | 0 |
| 2009 | 36 | 0 |
| 2010 | 32 | 1 |
| 2011 | 33 | 0 |
| 2012 | 15 | 0 |
| 2013 | 22 | 0 |
| 2014 | 14 | 0 |
| 2015 | 14 | 1 |
| 2016 | 5 | 1 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 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.
4 devices in this family have 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? (5)
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 |
|---|---|---|---|
| * | K210472 | SPINEART Navigation Instrument SystemSummary page 5…82.4560 Product Code(s) OLO | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K210472, K241644 4| | SPINEART Navigation Instrument System OoLO K261113 Op.nTM Spine Navigation and Robotic Guidance OLO Device Descrip… | 2021 |
| * | K241644 | SPINEART Navigation Instrument SystemSummary page 5…Product Code(s) OLO | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K210472, K241644 4| | SPINEART Navigation Instrument System OoLO K261113 Op.nTM Spine Navigation and Robotic Guidance OLO Device Description Summ… | 2024 |
| * | K261113 | Op.n™ Spine Navigation and Robotic Guidance Cleared while this submission was under review Summary page 5…s 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K210472, K241644 4| | SPINEART Navigation Instrument System OoLO K261113 Op.nTM Spine Navigation and Robotic Guidance OLO Device Description Summary 21 CFR 807.92(a)(4) The SPINEART Navigation reusabl… | 2026 |
| * | K242890 | SPINEART Navigation Instrument SystemSummary page 6…ions for Use Comparison 21 CFR 807.92(a)(5) Compared to the predicate devices K210472, K241644, K242890 and 1<254158, the modification to the indications for use is to add the option of using the already cleared SPINEART Navigation R… | 2025 |
| * | K254158 | SPINEART Navigation Instrument SystemSummary page 6…the subject SPINEART Navigation Reusable Instrument system are similar as predicate devices (SPINEART Navigation Reusable Instrument system K210472, K241644, K242890 and K254158). Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) Life… | 2026 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 Class I)
No FDA recall names this 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.
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 4 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 5 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
- K070106VV Fluoro 3DBrainlab AG · 2007 · 5 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 7 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 7 months on median.
- 100 of the 727 ancestors have a recall of any class; 4 have a Class I recall.
- 4 other devices also cite its predicate K210472.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 SPINEART Navigation reusable instruments are intended to be used during the preparation and placement of SPINEART PERLA TL screws during thoracolumbar spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SPINEART Navigation reusable instruments are specifically designed for use with eCential Op.n PERLA® TL Nav or with Perla by Spineart device. It is indicated for…
Read the full statement (311 words)
The SPINEART Navigation reusable instruments are intended to be used during the preparation and placement of SPINEART PERLA TL screws during thoracolumbar spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SPINEART Navigation reusable instruments are specifically designed for use with eCential Op.n PERLA® TL Nav or with Perla by Spineart device. It is indicated for population with medical conditions requiring the placement of thoracolumbar spinal screws and for which the use of stereotactic surgery may be considered to be appropriate and where reference to a rigid anatomical structure, such as a vertebra, can be identified. The guidance is based on an intra-operative surgical plan developed with Op.n PERLA® TL Nav Software or with Perla by Spineart software and based on intra-operative 3D images provided by a compatible imaging system. eCential Op.n PERLA® TL Nav device is intended to be used for thoracolumbar vertebrae surgery. eCential Perla by Spineart device is intended to be used for thoracolumbar + S1 vertebrae surgery.
The SPINEART Robotic reusable instruments are intended to be used during the preparation and placement of SPINEART PERLA TL screws during thoracolumbar spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SPINEART Robotic reusable instruments are specifically designed for use with eCential Perla by Spineart device. It is indicated for population with medical conditions requiring the placement of thoracolumbar spinal screws and for which the use of stereotactic surgery with robotic arm guidance, may be considered to be appropriate and where reference to a rigid anatomical structure, such as a vertebra, can be identified. The guidance is based on an intra-operative surgical plan developed with Perla by Spineart software, followed by related robotic arm positioning and instrument guiding, and checked on intra-operative 3D images provided by a compatible imaging system.
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/K261205 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261205: SPINEART Navigation Instrument System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261205
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026