510(k) · Cleared
ClearedCorelink 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 Dec 13, 2019 as substantially equivalent to K161210 (Medtronic Sofamor Danek, 2016) and 3 other predicates after a 441-day review. Its family tree reaches back 17 generations to 2004. 5 later devices descend from it.
- Decided
- Dec 13, 2019
- Review
- 441 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 17 generations to K040583 (2004). 219 ancestors in all, the oldest K841189 (1984). 5 later devices descend from it, 1 citing it directly.
- Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations between
- 3 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 2 generations backK143375 CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- 1 generation backK153203 Navigation InstrumentsGlobus Medical, Inc. · 2016
- This deviceK182731 Corelink Navigation InstrumentsCorelink, LLC · 2019
- Descendant · cites it directly · 4 of its ownK212825 CoreLink Navigation InstrumentsCorelink, LLC · 2021
- Descendant · 2 generations on · 1 of its ownK220973 CoreLink Navigation InstrumentsCorelink, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK232116 CoreLink Navigation InstrumentsCorelink, LLC · 2023
- Descendant · 3 generations on · 0 of its ownK230880 CoreLink Navigation InstrumentsCorelink, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK214059 CoreLink Navigation InstrumentsCorelink, LLC · 2022
Show all 17 generations
- Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 16 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 14 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 13 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 12 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 11 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 10 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 9 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 8 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 7 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 6 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 5 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 4 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 3 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 2 generations backK143375 CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- 1 generation backK153203 Navigation InstrumentsGlobus Medical, Inc. · 2016
- This deviceK182731 Corelink Navigation InstrumentsCorelink, LLC · 2019
Most influential descendants
Showing 5 of 5 · See all- K212825CoreLink Navigation InstrumentsCorelink, LLC · 2021 · cites it directly4descendants
- K220973CoreLink Navigation InstrumentsCorelink, LLC · 2022 · 2 generations on1descendant
- K232116CoreLink Navigation InstrumentsCorelink, LLC · 2023 · 2 generations on0descendants
- K230880CoreLink Navigation InstrumentsCorelink, LLC · 2023 · 3 generations on0descendants
- K214059CoreLink Navigation InstrumentsCorelink, LLC · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −16 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −15 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −14 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −13 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −12 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −11 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −10 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −9 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −8 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −7 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −6 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −5 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −4 | K122862 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −3 | K141605 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| −2 | K143375 | CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −1 | K153203 | Navigation Instruments | Globus Medical, Inc. | 2016 | — |
| 0 (this device) | K182731 | Corelink Navigation Instruments | Corelink, LLC | 2019 | — |
| +1 | K212825 | CoreLink Navigation Instruments | Corelink, LLC | 2021 | — |
| +2 | K220973 | CoreLink Navigation Instruments | Corelink, LLC | 2022 | — |
| +2 | K232116 | CoreLink Navigation Instruments | Corelink, LLC | 2023 | — |
| +3 | K230880 | CoreLink Navigation Instruments | Corelink, LLC | 2023 | — |
| +2 | K214059 | CoreLink Navigation Instruments | Corelink, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 8 | 0 |
| 1996 | 5 | 0 |
| 1997 | 5 | 0 |
| 1998 | 6 | 0 |
| 1999 | 6 | 0 |
| 2000 | 12 | 0 |
| 2001 | 15 | 0 |
| 2002 | 13 | 0 |
| 2003 | 12 | 0 |
| 2004 | 25 | 0 |
| 2005 | 17 | 0 |
| 2006 | 8 | 0 |
| 2007 | 5 | 0 |
| 2008 | 8 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 8 | 0 |
| 2012 | 3 | 0 |
| 2013 | 6 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 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? (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 |
|---|---|---|---|
| * | K161210 | RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Summary page 4…560 and Number Common Name Navigation Instruments Product Code / Panel OLO, Orthopedic Predicate Device Medtronic Navigated Reusable Instruments, K161210 (Primary) Globus Navigation Instruments, K153203 Alphatec… | 2016 |
| * | K153203 | Navigation InstrumentsSummary page 4…pedic Predicate Device Medtronic Navigated Reusable Instruments, K161210 (Primary) Globus Navigation Instruments, K153203 Alphatec Navigation Instruments, K153603 SI-BONE iFuse Navigation, K172268 Speci… | 2016 |
| * | K153603 | Alphatec Navigation InstrumentsSummary page 4…uments, K161210 (Primary) Globus Navigation Instruments, K153203 Alphatec Navigation Instruments, K153603 SI-BONE iFuse Navigation, K172268 Special Controls N/A Device Description CoreLink Navigation… | 2016 |
| * | K172268 | iFuse Implant System- iFuse NavigationSummary page 4…Globus Navigation Instruments, K153203 Alphatec Navigation Instruments, K153603 SI-BONE iFuse Navigation, K172268 Special Controls N/A Device Description CoreLink Navigation Instruments are non-sterile, re-… | 2017 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212825 | CoreLink Navigation Instruments | 2021 | 4 |
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 15 years and passes through 5 companies; a new generation was cleared every 5 months on median.
- 30 of the 219 ancestors have a recall of any class.
- Of its descendants, K212825 (Corelink, LLC, 2021) has gone furthest, with 4 descendants of its own.
- 26 other devices also cite its predicate K161210.
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?
CoreLink Navigation Instruments are intended to be used in the preparation and placement of CoreLink screws (Tiger and Entasis) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® 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, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182731 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182731: Corelink Navigation Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182731
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