510(k) · Cleared
ClearedK2M Navigation Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K2m, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on Aug 7, 2020 as substantially equivalent to K171321 (K2m, 2017) and 2 other predicates after a 112-day review. Its family tree reaches back 23 generations to 1985. 1 of the 501 devices in its family, counting itself, has a Class I recall.
- Decided
- Aug 7, 2020
- Review
- 112 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 23 generations to K853033 (1985). 500 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 501 devices in this family, counting this one, has a Class I recall.
- Root · 23 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 19 generations between
- 3 generations backK151727 Everest Spinal SystemK2m, Inc. · 2015
- 2 generations backK161369 EVEREST Spinal SystemK2m, Incorporated · 2016
- 1 generation backK171321 K2M Navigation InstrumentsK2m · 2017 · Recalled
- This deviceK201006 K2M Navigation InstrumentsK2m, Inc. · 2020
Show all 23 generations
- Root · 23 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 22 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 21 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 20 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 19 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 18 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 17 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 16 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 15 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 14 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 13 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 12 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 11 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 10 generations backK121016 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
- 9 generations backK130330 Range Spinal SystemK2m, Inc. · 2013
- 8 generations backK131784 Range Spinal SystemK2m, Inc. · 2013
- 7 generations backK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
- 6 generations backK141873 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
- 5 generations backK143334 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
- 4 generations backK150325 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
- 3 generations backK151727 Everest Spinal SystemK2m, Inc. · 2015
- 2 generations backK161369 EVEREST Spinal SystemK2m, Incorporated · 2016
- 1 generation backK171321 K2M Navigation InstrumentsK2m · 2017 · Recalled
- This deviceK201006 K2M Navigation InstrumentsK2m, Inc. · 2020
Class I recalls in this family
- K070106 VV Fluoro 3D3 generations back · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −22 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −21 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −20 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −19 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −18 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −17 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −16 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −15 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −14 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −13 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −12 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −11 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| −10 | K121016 | Range Spinal System (Mesa and Denali) | K2m, Inc. | 2012 | — |
| −9 | K130330 | Range Spinal System | K2m, Inc. | 2013 | — |
| −8 | K131784 | Range Spinal System | K2m, Inc. | 2013 | — |
| −7 | K133944 | Range, Spinal System, Everest Spinal System | K2m, Inc. | 2014 | — |
| −6 | K141873 | Range/Mesa/Denali Spinal System | K2m, Inc. | 2014 | — |
| −5 | K143334 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2015 | — |
| −4 | K150325 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2015 | — |
| −3 | K151727 | Everest Spinal System | K2m, Inc. | 2015 | — |
| −2 | K161369 | EVEREST Spinal System | K2m, Incorporated | 2016 | — |
| −1 | K171321 | K2M Navigation Instruments | K2m | 2017 | 1 |
| 0 (this device) | 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 | 4 | 0 |
| 1994 | 6 | 0 |
| 1995 | 15 | 0 |
| 1996 | 9 | 0 |
| 1997 | 11 | 0 |
| 1998 | 18 | 0 |
| 1999 | 16 | 0 |
| 2000 | 24 | 0 |
| 2001 | 38 | 0 |
| 2002 | 26 | 0 |
| 2003 | 25 | 0 |
| 2004 | 48 | 0 |
| 2005 | 38 | 0 |
| 2006 | 25 | 0 |
| 2007 | 22 | 1 |
| 2008 | 27 | 0 |
| 2009 | 21 | 0 |
| 2010 | 16 | 0 |
| 2011 | 23 | 0 |
| 2012 | 13 | 0 |
| 2013 | 13 | 0 |
| 2014 | 4 | 0 |
| 2015 | 8 | 0 |
| 2016 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 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? (3)
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 |
|---|---|---|---|
| * | K171321 | K2M Navigation InstrumentsSummary page 4…xic Instruments Regulation Number: 21 CFR 882.4560 Product Code: OLO Predicate Devices: Primary Predicate: K2M Navigation Instruments (K171321) Additional Predicates: Brainlab Compatible K2M Navigation Instruments… | 2017 |
| * | K181890 | Brainlab Compatible K2M Navigation InstrumentsSummary page 4…e: K2M Navigation Instruments (K171321) Additional Predicates: Brainlab Compatible K2M Navigation Instruments (K181890) Stryker Navigation Enabled Instruments (K183381) Device Description: K2M Navigation Instru… | 2018 |
| * | K183381 | Navigation Enabled InstrumentsSummary page 4…al Predicates: Brainlab Compatible K2M Navigation Instruments (K181890) Stryker Navigation Enabled Instruments (K183381) Device Description: K2M Navigation Instruments are nonsterile, reusable surgical instruments… | 2019 |
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.
- K070106VV Fluoro 3DBrainlab AG · 2007 · 3 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 35 years and passes through 9 companies; a new generation was cleared every 10 months on median.
- 54 of the 500 ancestors have a recall of any class; 1 has 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. 2020, 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, and Yukon) 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. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition…
Read the full statement (132 words)
K2M Navigation Instruments are intended to be used in the preparation and placement of K2M screws (Denali, Mesa, Everest, and Yukon) 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. 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 a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Navigated Screw Inserters are also compatible with the Medtronic [IPC POWEREASE System. The K2M Navigation Instruments are not intended for navigation of occipital screws.
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/K201006 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201006: 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/K201006
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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