510(k) · Cleared
ClearedFLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SeaSpine Orthopedics Corporation · OLO Orthopedic Stereotaxic Instrument
Cleared on Apr 2, 2025 as substantially equivalent to K222753 (SeaSpine Orthopedics Corporation, 2022) and 1 other predicate after a 126-day review. Its family tree reaches back 21 generations to 2001. 4 of the 336 devices in its family, counting itself, have a Class I recall.
- Decided
- Apr 2, 2025
- Review
- 126 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 21 generations to K003155 (2001). 335 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet. 4 of the 336 devices in this family, counting this one, have a Class I recall.
- Root · 21 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 17 generations between
- 3 generations backK192336 Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2019
- 2 generations backK211441 Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2021
- 1 generation backK240625 CORUS Navigation Access SystemProvidence Medical Technology, Inc. · 2024
- This deviceK243659 FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation · 2025
Show all 21 generations
- Root · 21 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 20 generations backK012254 VBROsteotech, Inc. · 2001
- 19 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 18 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 17 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 16 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 12 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 11 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 10 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 9 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 8 generations backK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
- 7 generations backK122037 Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion…Medtronic Sofamor Danek, Inc. · 2013
- 6 generations backK142559 ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 5 generations backK163581 Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2017
- 4 generations backK191039 Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc. · 2019
- 3 generations backK192336 Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2019
- 2 generations backK211441 Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2021
- 1 generation backK240625 CORUS Navigation Access SystemProvidence Medical Technology, Inc. · 2024
- This deviceK243659 FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −20 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −19 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −18 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −17 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −16 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −15 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −14 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −13 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −12 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −11 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −10 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −9 | K100214 | Cornerstone PSR Cervical Interbody Fusion Device | Medtronic Sofamor Danek | 2010 | — |
| −8 | K111264 | Cornerstone (R) PSR Cervical Fusion System | Medtronic Sofamor Danek USA | 2011 | — |
| −7 | K122037 | Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System… | Medtronic Sofamor Danek, Inc. | 2013 | — |
| −6 | K142559 | ELEVATE Spinal System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −5 | K163581 | Navigated ELEVATE Inserter, Navigated Disc Prep Instruments | Medtronic Sofamor Danek USA, Inc. | 2017 | — |
| −4 | K191039 | Navigated T2 STRATOSPHERE Inserters and Navigated Templates | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| −3 | K192336 | Navigated Anterolateral Disc Prep Instruments | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| −2 | K211441 | Navigated Anterolateral Disc Prep Instruments | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| −1 | K240625 | CORUS Navigation Access System | Providence Medical Technology, Inc. | 2024 | — |
| 0 (this device) | K243659 | FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments | SeaSpine Orthopedics Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1984 | 3 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 7 | 0 |
| 1995 | 15 | 0 |
| 1996 | 6 | 0 |
| 1997 | 9 | 0 |
| 1998 | 9 | 0 |
| 1999 | 13 | 0 |
| 2000 | 13 | 0 |
| 2001 | 22 | 1 |
| 2002 | 19 | 0 |
| 2003 | 21 | 0 |
| 2004 | 27 | 0 |
| 2005 | 15 | 0 |
| 2006 | 10 | 0 |
| 2007 | 14 | 0 |
| 2008 | 24 | 0 |
| 2009 | 11 | 0 |
| 2010 | 9 | 0 |
| 2011 | 13 | 0 |
| 2012 | 6 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 1 |
| 2016 | 2 | 1 |
| 2017 | 4 | 1 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K222753 | SeaSpine 7D Navigation InstrumentsSummary page 5…ade Name(s) Manufacturer Primary Predicate Device SeaSpine Orthopedics K222753 OLO SeaSpine 7D Navigation Instruments… | 2022 |
| * | K240625 | CORUS Navigation Access SystemSummary page 5…Corporation Additional Device(s) Providence Medical K240625 OLO CORUS™ Navigation Access System… | 2024 |
| † | K192140 | 7D Surgical System | 2019 |
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.
- K162309StealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc. · 2017 · 6 generations back · ◆ in the 2017 ancestors bar of FIG. 12 Class I recalls
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 7 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 8 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
- K003837Flexiview 8800 Digital Mobile Imaging SystemGe Oec Medical Systems · 2001 · 14 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
- 46 of the 335 ancestors have a recall of any class; 4 have a Class I recall.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 FLASH™ Facet Fusion Instruments are intended to be used during spinal surgery to assist the surgeon in precisely locating and preparing anatomical structures, specifically the lumbar facet joints, in either open or minimally invasive procedures. The FLASH™ Facet Fusion Instruments are specifically designed for use with the 7D Surgical System™ which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and…
Read the full statement (158 words)
The FLASH™ Facet Fusion Instruments are intended to be used during spinal surgery to assist the surgeon in precisely locating and preparing anatomical structures, specifically the lumbar facet joints, in either open or minimally invasive procedures. The FLASH™ Facet Fusion Instruments are specifically designed for use with the 7D Surgical System™ which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure can be identified.
The IsoTis® Facet Fusion Instruments are intended to be used during spinal surgery to assist the surgeon in precisely locating and preparing anatomical structures, specifically the lumbar facet joints, in either open or minimally invasive procedures. The IsoTis® Facet Fusion Instruments are specifically designed for use with the 7D Surgical System™ which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure can be identified.
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/K243659 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243659: FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243659
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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