510(k) · Cleared
Recalled · Class II · 2025SeaSpine Navigation System
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 May 11, 2018 as substantially equivalent to K124004 (Medtronic Navigation, Inc., 2013) and 3 other predicates after a 263-day review. Its family tree reaches back 11 generations to 1986. 60 later devices descend from it. It has been recalled once.
- Decided
- May 11, 2018
- Review
- 263 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 11 generations to K862807 (1986). 65 ancestors in all, the oldest K842956 (1984). 60 later devices descend from it, 5 citing it directly.
- Root · 11 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 7 generations between
- 3 generations backK123270 Powerease SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 2 generations backK140454 Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 2014 · Recalled
- 1 generation backK143628 Navigated Vertex Select InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- This deviceK172517 SeaSpine Navigation SystemSeaSpine Orthopedics Corporation · 2018
- Descendant · cites it directly · 49 of its ownK191648 Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation · 2019
- Descendant · 2 generations on · 47 of its ownK211606 Mariner Deformity SystemSeaSpine Orthopedics Corporation · 2021 · Recalled
- Descendant · 3 generations on · 46 of its ownK212692 Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation · 2021
- Descendant · 4 generations on · 32 of its ownK220195 iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc. · 2022
- Descendant · 5 generations on · 20 of its ownK222774 iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. · 2022
Show all 11 generations
- Root · 11 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 10 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 9 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
- 8 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- 7 generations backK990524 E9000 SystemLinvatec Corp. · 1999
- 6 generations backK012456 Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001
- 5 generations backK081277 XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · Recalled
- 4 generations backK111520 Ipc Powerease SystemMedtronic Xomed, Inc. · 2011 · Recalled
- 3 generations backK123270 Powerease SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 2 generations backK140454 Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 2014 · Recalled
- 1 generation backK143628 Navigated Vertex Select InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- This deviceK172517 SeaSpine Navigation SystemSeaSpine Orthopedics Corporation · 2018
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 60 · See all- K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation · 2019 · cites it directly49descendants
- K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation · 2021 · 2 generations on47descendants
- K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation · 2021 · 3 generations on46descendants
- K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc. · 2022 · 4 generations on32descendants
- K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. · 2022 · 5 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −10 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −9 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| −8 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| −7 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| −6 | K012456 | Sodem High Speed System (Electric) (Ear, Nose, and Throat) | Sodemsystems | 2001 | — |
| −5 | K081277 | XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc) | Medtronic Xomed, Inc. | 2008 | 1 |
| −4 | K111520 | Ipc Powerease System | Medtronic Xomed, Inc. | 2011 | 2 |
| −3 | K123270 | Powerease System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −2 | K140454 | Navigated CD Horizon Solera Screwdriver/Taps | Medtronic Sofamor Danek USA, Inc. | 2014 | 1 |
| −1 | K143628 | Navigated Vertex Select Instruments | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| 0 (this device) | K172517 | SeaSpine Navigation System | SeaSpine Orthopedics Corporation | 2018 | — |
| +1 | K191648 | Mariner MIS Pedicle Screw System; SeaSpine Navigation System | SeaSpine Orthopedics Corporation | 2019 | — |
| +2 | K211606 | Mariner Deformity System | SeaSpine Orthopedics Corporation | 2021 | 1 |
| +3 | K212692 | Mariner Pedicle Screw System | SeaSpine Orthopedics Corporation | 2021 | — |
| +4 | K220195 | iFuse Bedrock Granite™ Implant System | SI-BONE, Inc. | 2022 | — |
| +5 | K222774 | iFuse Bedrock Granite® Implant System | SI-BONE, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2008 | 2 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 7 | 0 |
| 2024 | 9 | 0 |
| 2025 | 17 | 0 |
| 2026 | 17 | 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 |
|---|---|---|---|
| * | K124004 | Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy TapsSummary page 4…OLO Legally Marketed Predicate Devices 510(k) Product Code Trade Name Manufacturer Number PRIMARY PREDICATE Device K124004 Navigated CD Horizon Solera Medtronic Sofamor OLO, HBE K140454… | 2013 |
| * | K140454 | Navigated CD Horizon Solera Screwdriver/TapsSummary page 4…anufacturer Number PRIMARY PREDICATE Device K124004 Navigated CD Horizon Solera Medtronic Sofamor OLO, HBE K140454 Screwdrivers and Taps Danek, USA Inc. SECONDARY PREDICATE Devices… | 2014 |
| * | K143628 | Navigated Vertex Select InstrumentsSummary page 4…Screwdrivers and Taps Danek, USA Inc. SECONDARY PREDICATE Devices Navigated VERTEX SELECT Medtronic Sofamor K143628 OLO Instruments Danek, USA Inc.… | 2015 |
| * | K153603 | Alphatec Navigation InstrumentsSummary page 4…OLO Instruments Danek, USA Inc. Alphatec Navigation K153603 OLO Alphatec Spine Inc. Instru… | 2016 |
What descends from it? (60)
See all 605 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 17, 2025 | Class II | Z-0937-2026 | Labeling design | The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and Medtronic s Infinity system toolcards as compatible with the NorthStar OCT Navigation Instruments. However, the NorthStar OCT… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 10 of the 65 ancestors have a recall of any class.
- Of its descendants, K191648 (SeaSpine Orthopedics Corporation, 2019) has gone furthest, with 49 descendants of its own.
- 14 other devices also cite its predicate K124004.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 SeaSpine Navigation System reusable instruments are intended to be used during the preparation and placement of SeaSpine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SeaSpine Navigation reusable instruments are specifically designed for use with the Medtronic Stealth Station System, which is indicated for any medical condition in which the use of…
Read the full statement (107 words)
The SeaSpine Navigation System reusable instruments are intended to be used during the preparation and placement of SeaSpine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SeaSpine Navigation reusable instruments are specifically designed for use with the Medtronic Stealth Station 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 a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172517 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172517: SeaSpine Navigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172517
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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