510(k) · Cleared
Recalled · Class II · 2016K2M Navigation Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K2m · OLO Orthopedic Stereotaxic Instrument
Cleared on Aug 30, 2017 as substantially equivalent to K143375 (Medtronic Sofamor Danek USA, Inc., 2015) and 5 other predicates after a 118-day review. Its family tree reaches back 22 generations to 1985. 1 later device descends from it. It has been recalled once.
- Decided
- Aug 30, 2017
- Review
- 118 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 22 generations to K853033 (1985). 421 ancestors in all, the oldest K781443 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 22 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 18 generations between
- 3 generations backK150325 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
- 2 generations backK151727 Everest Spinal SystemK2m, Inc. · 2015
- 1 generation backK161369 EVEREST Spinal SystemK2m, Incorporated · 2016
- This deviceK171321 K2M Navigation InstrumentsK2m · 2017
- Descendant · cites it directly · 0 of its ownK201006 K2M Navigation InstrumentsK2m, Inc. · 2020
Show all 22 generations
- Root · 22 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 21 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 20 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 19 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 18 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 17 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 16 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 15 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 14 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 13 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 12 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 11 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 10 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 9 generations backK121016 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
- 8 generations backK130330 Range Spinal SystemK2m, Inc. · 2013
- 7 generations backK131784 Range Spinal SystemK2m, Inc. · 2013
- 6 generations backK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
- 5 generations backK141873 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
- 4 generations backK143334 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
- 3 generations backK150325 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
- 2 generations backK151727 Everest Spinal SystemK2m, Inc. · 2015
- 1 generation backK161369 EVEREST Spinal SystemK2m, Incorporated · 2016
- This deviceK171321 K2M Navigation InstrumentsK2m · 2017
Most influential descendants
Showing 1 of 1 · See all- K201006K2M Navigation InstrumentsK2m, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −21 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −20 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −19 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −18 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −17 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −16 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −15 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −14 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −13 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −12 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −11 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −10 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| −9 | K121016 | Range Spinal System (Mesa and Denali) | K2m, Inc. | 2012 | — |
| −8 | K130330 | Range Spinal System | K2m, Inc. | 2013 | — |
| −7 | K131784 | Range Spinal System | K2m, Inc. | 2013 | — |
| −6 | K133944 | Range, Spinal System, Everest Spinal System | K2m, Inc. | 2014 | — |
| −5 | K141873 | Range/Mesa/Denali Spinal System | K2m, Inc. | 2014 | — |
| −4 | K143334 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2015 | — |
| −3 | K150325 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2015 | — |
| −2 | K151727 | Everest Spinal System | K2m, Inc. | 2015 | — |
| −1 | K161369 | EVEREST Spinal System | K2m, Incorporated | 2016 | — |
| 0 (this device) | K171321 | K2M Navigation Instruments | K2m | 2017 | — |
| +1 | K201006 | K2M Navigation Instruments | K2m, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 4 | 0 |
| 1992 | 7 | 0 |
| 1993 | 3 | 0 |
| 1994 | 6 | 0 |
| 1995 | 14 | 0 |
| 1996 | 9 | 0 |
| 1997 | 9 | 0 |
| 1998 | 17 | 0 |
| 1999 | 14 | 0 |
| 2000 | 23 | 0 |
| 2001 | 31 | 0 |
| 2002 | 21 | 0 |
| 2003 | 22 | 0 |
| 2004 | 44 | 0 |
| 2005 | 34 | 0 |
| 2006 | 21 | 0 |
| 2007 | 15 | 0 |
| 2008 | 21 | 0 |
| 2009 | 14 | 0 |
| 2010 | 12 | 0 |
| 2011 | 17 | 0 |
| 2012 | 11 | 0 |
| 2013 | 11 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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.
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? (6)
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 |
|---|---|---|---|
| * | K143375 | CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsSummary page 4…Class II Classification Name(s): Stereotaxic instrument (21 CFR 882.4560, Product Code OLO) Predicate Device(s) Primary Predicate: Medtronic Navigated Instruments (K143375) Additional Predicates: Medtronic Medtronic Navigated Instruments (K143628, K143375) K2M Range/Mesa/Denali Spinal System (K070229… | 2015 |
| * | K143628 | Navigated Vertex Select InstrumentsSummary page 4…0, Product Code OLO) Predicate Device(s) Primary Predicate: Medtronic Navigated Instruments (K143375) Additional Predicates: Medtronic Medtronic Navigated Instruments (K143628, K143375) K2M Range/Mesa/Denali Spinal System (K070229, K153031) K2M Everest Spinal System (K103440, K161369) Device Description… | 2015 |
| * | K070229 | Range Spinal SystemSummary page 4…icate: Medtronic Navigated Instruments (K143375) Additional Predicates: Medtronic Medtronic Navigated Instruments (K143628, K143375) K2M Range/Mesa/Denali Spinal System (K070229, K153031) K2M Everest Spinal System (K103440, K161369) Device Description K2M Navigation Instruments are manual surgical instrum… | 2007 |
| * | K153031 | RANGE/DENALI/MESA Spinal SystemSummary page 4…dtronic Navigated Instruments (K143375) Additional Predicates: Medtronic Medtronic Navigated Instruments (K143628, K143375) K2M Range/Mesa/Denali Spinal System (K070229, K153031) K2M Everest Spinal System (K103440, K161369) Device Description K2M Navigation Instruments are manual surgical instruments inte… | 2015 |
| * | K103440 | Everest Spinal SystemSummary page 4…75) Additional Predicates: Medtronic Medtronic Navigated Instruments (K143628, K143375) K2M Range/Mesa/Denali Spinal System (K070229, K153031) K2M Everest Spinal System (K103440, K161369) Device Description K2M Navigation Instruments are manual surgical instruments intended be used when implanting previou… | 2011 |
| * | K161369 | EVEREST Spinal SystemSummary page 4…ional Predicates: Medtronic Medtronic Navigated Instruments (K143628, K143375) K2M Range/Mesa/Denali Spinal System (K070229, K153031) K2M Everest Spinal System (K103440, K161369) Device Description K2M Navigation Instruments are manual surgical instruments intended be used when implanting previously clear… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201006 | K2M Navigation Instruments | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 2, 2016 | Class II | Z-0052-2020 | Nonconforming Material/Component | Instruments were developed without adequate consideration given to the need for a new regulatory filing. This event was reported to FDA as part of Stryker's retrospective review of K2M product field actions; recall actions were completed… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 9 companies; a new generation was cleared every 10 months on median.
- 43 of the 421 ancestors have a recall of any class.
- Of its descendants, K201006 (K2m, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 13 other devices also cite its predicate K143375.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
K2M Navigation Instruments are intended to be used in the preparation and placement of K2M screws (DENALI, MESA, EVEREST) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. MESA screw navigation is intended for open procedures only. The K2M Navigation Instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition…
Read the full statement (113 words)
K2M Navigation Instruments are intended to be used in the preparation and placement of K2M screws (DENALI, MESA, EVEREST) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. MESA screw navigation is intended for open procedures only. The K2M Navigation 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 a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy
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/K171321 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171321: K2M 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/K171321
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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