510(k) · Cleared
ClearedCoreLink Robotic Navigation Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corelink, LLC · OLO Orthopedic Stereotaxic Instrument
Cleared on Oct 27, 2023 as substantially equivalent to K171651 (Globus Medical, Inc., 2017) and 3 other predicates after a 157-day review. Its family tree reaches back 22 generations to 2001. 1 of the 786 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 27, 2023
- Review
- 157 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 22 generations to K003155 (2001). 785 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 786 devices in this family, counting this one, has a Class I recall.
- Root · 22 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 18 generations between
- 3 generations backK173130 Reform® Midline Cortical Screw SystemPrecision Spine, Inc. · 2017
- 2 generations backK210539 CoreLink Midline Fixation SystemCorelink, LLC · 2021
- 1 generation backK221776 NextGen Pedicle Screw SystemCorelink, LLC · 2022
- This deviceK231494 CoreLink Robotic Navigation InstrumentsCorelink, LLC · 2023
Show all 22 generations
- Root · 22 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 21 generations backK012254 VBROsteotech, Inc. · 2001
- 20 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 19 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 18 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 17 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 16 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 13 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
- 12 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 11 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
- 10 generations backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 9 generations backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
- 8 generations backK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
- 7 generations backK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
- 6 generations backK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
- 5 generations backK143248 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014
- 4 generations backK150856 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015
- 3 generations backK173130 Reform® Midline Cortical Screw SystemPrecision Spine, Inc. · 2017
- 2 generations backK210539 CoreLink Midline Fixation SystemCorelink, LLC · 2021
- 1 generation backK221776 NextGen Pedicle Screw SystemCorelink, LLC · 2022
- This deviceK231494 CoreLink Robotic Navigation InstrumentsCorelink, LLC · 2023
Class I recalls in this family
- K100952 Modification to Synthes Matrix System2 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −21 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −20 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −19 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −18 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −17 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −16 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −15 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −14 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −13 | K061938 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2006 | — |
| −12 | K062427 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −11 | K070742 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | 2007 | — |
| −10 | K110522 | Vertex Reconstruction System, Vertex Select Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −9 | K113593 | Nextgen Altius Oct System | Biomet Spine (Aka Ebi, LLC) | 2012 | — |
| −8 | K123549 | Polaris Spinal System - Ballista II Percutaneous Screw Placement System | Biomet Spine (Aka Ebi, LLC) | 2013 | 2 |
| −7 | K131615 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2013 | — |
| −6 | K133746 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2014 | 1 |
| −5 | K143248 | Reform Pedicle Screw System | Precision Spine, Inc. | 2014 | — |
| −4 | K150856 | Reform Pedicle Screw System | Precision Spine, Inc. | 2015 | — |
| −3 | K173130 | Reform® Midline Cortical Screw System | Precision Spine, Inc. | 2017 | — |
| −2 | K210539 | CoreLink Midline Fixation System | Corelink, LLC | 2021 | — |
| −1 | K221776 | NextGen Pedicle Screw System | Corelink, LLC | 2022 | — |
| 0 (this device) | K231494 | CoreLink Robotic Navigation Instruments | Corelink, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 1 | 0 |
| 1981 | 2 | 0 |
| 1984 | 2 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 3 | 0 |
| 1988 | 2 | 0 |
| 1989 | 5 | 0 |
| 1990 | 4 | 0 |
| 1991 | 2 | 0 |
| 1992 | 8 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 21 | 0 |
| 1996 | 23 | 0 |
| 1997 | 17 | 0 |
| 1998 | 28 | 0 |
| 1999 | 26 | 0 |
| 2000 | 44 | 0 |
| 2001 | 50 | 0 |
| 2002 | 45 | 0 |
| 2003 | 38 | 0 |
| 2004 | 65 | 0 |
| 2005 | 54 | 0 |
| 2006 | 43 | 0 |
| 2007 | 28 | 0 |
| 2008 | 46 | 0 |
| 2009 | 33 | 0 |
| 2010 | 33 | 1 |
| 2011 | 33 | 0 |
| 2012 | 19 | 0 |
| 2013 | 18 | 0 |
| 2014 | 13 | 0 |
| 2015 | 16 | 0 |
| 2016 | 10 | 0 |
| 2017 | 5 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 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.
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? (4)
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 |
|---|---|---|---|
| * | K171651 | Excelsius GPSSummary page 5…anufacturer Product Code Predicate Name Type K171651 EXCELSIUS GPS Globus Medical Inc. OLO Primary K221776 NextG… | 2017 |
| * | K221776 | NextGen Pedicle Screw SystemSummary page 5…Type K171651 EXCELSIUS GPS Globus Medical Inc. OLO Primary K221776 NextGen Pedicle Screw System CoreLink, LLC NKB Additional K210539 Co… | 2022 |
| * | K210539 | CoreLink Midline Fixation SystemSummary page 5…s Medical Inc. OLO Primary K221776 NextGen Pedicle Screw System CoreLink, LLC NKB Additional K210539 CoreLink Midline Fixation System CoreLink, LLC NKB Additional K133369 Ti… | 2021 |
| * | K133369 | Tiger Spine SystemSummary page 5…, LLC NKB Additional K210539 CoreLink Midline Fixation System CoreLink, LLC NKB Additional K133369 Tiger Spine System CoreLink, LLC NKB, KWP, MNH, MNI Additional PERFORMANCE DATA The… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 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.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 2 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 7 companies; a new generation was cleared every 10 months on median.
- 101 of the 785 ancestors have a recall of any class; 1 has a Class I recall.
- 27 other devices also cite its predicate K171651.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
CoreLink Robotic Navigation Instruments are indicated to be used during the preparation screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures for skeletally mature patients, where reference to a rigid anatomical structure such as vertebra can be identified. These instruments are designed for use with the Globus ExcelsiusGPS system, which is indicated for use as an…
Read the full statement (135 words)
CoreLink Robotic Navigation Instruments are indicated to be used during the preparation screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures for skeletally mature patients, where reference to a rigid anatomical structure such as vertebra can be identified. These instruments are designed for use with the Globus ExcelsiusGPS system, which is indicated for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231494 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231494: CoreLink Robotic Navigation Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231494
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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