510(k) Report

510(k) · Cleared

Cleared

GX Navigation Instrument System

K202836510(k) TraditionalCleared Aug 19, 2021328-day reviewClass II21 CFR 882.4560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Life Spine, Inc. · OLO Orthopedic Stereotaxic Instrument

Cleared on Aug 19, 2021 as substantially equivalent to K170679 (Medtronic Sofamor Danek, 2017) and 5 other predicates after a 328-day review. Its family tree reaches back 22 generations to 2004. 1 of the 585 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.

Decided
Aug 19, 2021
Review
328 days
Class
Class II
Product code
OLO
Recalls
None
Predicates
6

Its longest line of descent runs back 22 generations to K040583 (2004). 583 ancestors in all, the oldest K781443 (1978). 1 later device descends from it, 1 citing it directly. 1 of the 585 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2017: 2 other ancestors2015: 11 other ancestors2013: 14 other ancestors2012: 13 other ancestors2014: 11 other ancestors2011: 21 other ancestors2008: 32 other ancestors2007: 30 other ancestors2006: 36 other ancestors2018: 1 other ancestor2010: 23 other ancestors, 1 with a Class I recall12009: 26 other ancestors2005: 43 other ancestors2004: 55 other ancestors1996: 11 other ancestors1995: 16 other ancestors2016: 3 other ancestors2003: 32 other ancestors2002: 27 other ancestors2001: 37 other ancestors2000: 30 other ancestors1999: 19 other ancestors1998: 21 other ancestors1997: 14 other ancestors1994: 7 other ancestors1991: 1 other ancestor1988: 2 other ancestors1987: 1 other ancestor1993: 4 other ancestors1992: 7 other ancestors1990: 3 other ancestors1989: 1 other ancestor1986: 2 other ancestors1984: 2 other ancestors1978: 1 other ancestor1985: 2 other ancestors2026: 1 descendant cleared×7: 7 generations cleared close together, K040583 (2004), K041118 (2004), K042025 (2004), K043151 (2005), K050809 (2005), K052187 (2005), K053101 (2006) ×2: 2 generations cleared close together, K091442 (2009), K091974 (2009) K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010×2: 2 generations cleared close together, K112473 (2011), K113174 (2011) K121680 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012×2: 2 generations cleared close together, K131321 (2013), K132111 (2013) ×2: 2 generations cleared close together, K141604 (2014), K143684 (2015) K160989 · NuVasive® Reline® System · Nu Vasive, Incorporated · 2016K170126 · NuVasive® Reline® 4.5-5.0 System · Nu Vasive, Incorporated · 2017×2: 2 generations cleared close together, K182974 (2019), K191575 (2019) K200070 · ARx Spinal System · Life Spine, Inc. · 202019801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 18 other ancestors3 generations back: 32 other ancestors4 generations back: 82 other ancestors, 1 with a Class I recall15 generations back: 152 other ancestors6 generations back: 109 other ancestors7 generations back: 68 other ancestors8 generations back: 46 other ancestors9 generations back: 14 other ancestors10 generations back: 9 other ancestors11 generations back: 7 other ancestors12 generations back: 8 other ancestors13 generations back: 6 other ancestors14 generations back: 4 other ancestors15 generations back: 2 other ancestors 1 generation forward: 1 descendant K200070 · ARx Spinal System · Life Spine, Inc. · 2020K191575 · ARx Spinal System · Life Spine, Inc. · 2019K182974 · NuVasive Reline System · Nu Vasive, Incorporated · 2019K170126 · NuVasive® Reline® 4.5-5.0 System · Nu Vasive, Incorporated · 2017K160989 · NuVasive® Reline® System · Nu Vasive, Incorporated · 2016K143684 · NuVasive Reline System · Nu Vasive, Incorporated · 2015K141604 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2014K132111 · CD Horizon Spinal System · Medtronic Sofamor Danek USA · 2013K131321 · CD Horizon Spinal System · Medtronic Sofamor Danek USA · 2013K121680 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012K113174 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2011 · recalledK112473 · CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2011K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010K091974 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2009 · recalledK091442 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2009K053101 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2006K052187 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K050809 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2005K043151 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K042025 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2004 · recalledK041118 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek · 2004K040583 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2004−20−15−10−50
  1. Root · 22 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 18 generations between
  3. 3 generations backK182974 NuVasive Reline SystemNu Vasive, Incorporated · 2019
  4. 2 generations backK191575 ARx Spinal SystemLife Spine, Inc. · 2019
  5. 1 generation backK200070 ARx Spinal SystemLife Spine, Inc. · 2020
  6. This deviceK202836 GX Navigation Instrument SystemLife Spine, Inc. · 2021
  7. Descendant · cites it directly · 0 of its ownK260571 SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc. · 2026
Show all 22 generations
  1. Root · 22 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 21 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 20 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 19 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 18 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 17 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 16 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 15 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 14 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 13 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 12 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 11 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 10 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 9 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  15. 8 generations backK132111 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  16. 7 generations backK141604 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
  17. 6 generations backK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
  18. 5 generations backK160989 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
  19. 4 generations backK170126 NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated · 2017
  20. 3 generations backK182974 NuVasive Reline SystemNu Vasive, Incorporated · 2019
  21. 2 generations backK191575 ARx Spinal SystemLife Spine, Inc. · 2019
  22. 1 generation backK200070 ARx Spinal SystemLife Spine, Inc. · 2020
  23. This deviceK202836 GX Navigation Instrument SystemLife Spine, Inc. · 2021

Class I recalls in this family

  • K100952 Modification to Synthes Matrix System4 generations back · 2010

Most influential descendants

Showing 1 of 1 · See all
  • K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−22K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−21K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−20K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−19K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−18K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−17K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−16K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−15K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−14K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−13K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−12K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−11K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−10K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−9K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013—
−8K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013—
−7K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014—
−6K143684NuVasive Reline SystemNu Vasive, Incorporated2015—
−5K160989NuVasive® Reline® SystemNu Vasive, Incorporated2016—
−4K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated2017—
−3K182974NuVasive Reline SystemNu Vasive, Incorporated2019—
−2K191575ARx Spinal SystemLife Spine, Inc.2019—
−1K200070ARx Spinal SystemLife Spine, Inc.2020—
0 (this device)K202836GX Navigation Instrument SystemLife Spine, Inc.2021—
+1K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198420
198520
198620
198710
198820
198910
199030
199110
199270
199340
199470
1995160
1996110
1997140
1998210
1999190
2000300
2001370
2002270
2003320
2004550
2005430
2006360
2007300
2008320
2009260
2010231
2011210
2012130
2013140
2014110
2015110
201630
201720
201810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202610
FIG. 1 — Lineage of K202836, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K240662 Spine Guidance Software (version 5.0); Xia 3/…score 23.7 · 15 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…
Summary page 4
…struments Classification: CFR 882.4560, Class II, Stereotaxic instrument Product Code: OLO Primary Predicate: Medtronic CD Horizon (K170679) Additional Predicates: Life Spine Avatar/Nautilus & Centerline (K111953, K132760 & K151196) Lif…
Medtronic Sofamor Danek2017—
*K111953Nautilus Spinal System
Summary page 4
…trument Product Code: OLO Primary Predicate: Medtronic CD Horizon (K170679) Additional Predicates: Life Spine Avatar/Nautilus & Centerline (K111953, K132760 & K151196) Life Spine ARx Spinal System (K200070 & K191575) De…
Life Spine2012—
*K132760Nautilus Spinal System
Summary page 4
…Product Code: OLO Primary Predicate: Medtronic CD Horizon (K170679) Additional Predicates: Life Spine Avatar/Nautilus & Centerline (K111953, K132760 & K151196) Life Spine ARx Spinal System (K200070 & K191575) Device Desc…
Life Spine, Inc.2013—
*K151196Nautilus Spinal System
Summary page 4
…ry Predicate: Medtronic CD Horizon (K170679) Additional Predicates: Life Spine Avatar/Nautilus & Centerline (K111953, K132760 & K151196) Life Spine ARx Spinal System (K200070 & K191575) Device Description: The GX Navigation instruments…
Life Spine, Inc.2015—
*K200070ARx Spinal System
Summary page 4
…izon (K170679) Additional Predicates: Life Spine Avatar/Nautilus & Centerline (K111953, K132760 & K151196) Life Spine ARx Spinal System (K200070 & K191575) Device Description: The GX Navigation instruments are manufactured from Stainless Steel…
Life Spine, Inc.2020—
*K191575ARx Spinal System
Summary page 4
…Life Spine Avatar/Nautilus & Centerline (K111953, K132760 & K151196) Life Spine ARx Spinal System (K200070 & K191575) Device Description: The GX Navigation instruments are manufactured from Stainless Steel as specified in ASTM F899, non-sterile…
Life Spine, Inc.2019—

Also cleared against K170679: 15 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260

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 · 4 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 17 years and passes through 6 companies; a new generation was cleared every 7 months on median.
  • 72 of the 583 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K260571 (Life Spine, Inc., 2026) has gone furthest, with 0 descendants of its own.
  • 15 other devices also cite its predicate K170679.

How does its category compare?

All OLO devices

OLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

FDA decisions per year · OLO

40in 2025

2009: 112010: 92011: 112012: 72013: 72014: 102015: 102016: 142017: 332018: 242019: 352020: 342021: 282022: 402023: 452024: 442025: 402026 (partial year): 42
2007high 45 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OLO

119in 2025

2009: 126 days median2010: 113 days median2011: 138 days median2012: 129 days median2013: 137 days median2014: 119 days median2015: 176 days median2016: 120 days median2017: 91 days median2018: 97 days median2019: 95 days median2020: 89 days median2021: 91 days median2022: 89 days median2023: 90 days median2024: 90 days median2025: 119 days median2026 (partial year): 109 days median
2007high 176 (2015) · low 89 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OLO

1in 2025

2010: 12011: 12012: 12014: 32015: 22016: 32017: 22018: 12019: 12020: 62022: 52023: 7, 1 Class I2024: 42025: 12026 (partial year): 6
2007high 7 (2023) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · OLO

3,306in 2025

2008: 12009: 42010: 42011: 102012: 602013: 362014: 2452015: 4662016: 7502017: 1,0762018: 1,2302019: 1,5852020: 2,7462021: 1,6962022: 1,5682023: 1,4932024: 2,3532025: 3,306
2007high 3,306 (2025) · low 0 (2007)2025

MAUDE reports naming product code OLO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—01
20091112604
2010911314
201111138110
20127129160
20137137036
2014101193245
2015101762466
2016141203750
2017339121,076
2018249711,230
2019359511,585
2020348962,746
2021289101,696
2022408951,568
202345907 (1)1,493
2024449042,353
20254011913,306
2026421096—

What is it indicated for?

The GX Navigation Instruments are intended to be used during the preparation and placement of Life Spine screws 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…

Read the full statement (127 words)

The GX Navigation Instruments are intended to be used during the preparation and placement of Life Spine screws 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.

The GX Navigation Instruments are compatible with the following Life Spine implant systems:

ARX Spinal System, Avatar Extended Tab MIS System, Nautilus Thoracolumbar Spinal System, Centerline Thoracolumbar Spinal System and Centric-T System.

Indications for use as stated in the FDA summary.

Also cleared against K170679

15 other devices cite the same predicate.

  • K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc. · 2026
  • K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc. · 2026
  • K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc. · 2025
  • K243419Altus Spine Navigation SystemAltus Partners, LLC · 2025
  • K250182Innovasis Navigation InstrumentsInnovasis, Inc. · 20251 recall
  • K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC · 2023

More from Life Spine, Inc.

85 FDA decisions under this applicant name. See the company

  • K261430TruLift Expandable SystemLife Spine, Inc. · 2026
  • K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc. · 2026
  • K260837VersaLift Expandable SystemLife Spine, Inc. · 2026
  • K254274ARx® SAI Implant SystemLife Spine, Inc. · 2026
  • K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc. · 2026

Recent decisions in OLO

The OLO category page

  • K2604037D Surgical System (10-0001)7D Surgical ULC · 2026
  • K263234TMINI Miniature Robotic SystemTHINK Surgical, Inc. · 2026
  • K263154CarboClear® Cervical Navigated InstrumentsCarboFix Orhtopedics, Ltd. · 2026
  • K262257Spine Planning (3.0); Spine & Trauma Navigation; Alignment System SpineBrainlab SE · 2026
  • K262506Remex Spine Surgery Navigation - Universal InstrumentsRemex Medical Corp. · 2026

https://510kreport.com/device/K202836 · printed Nov 5, 2026

Cite this page

510(k) Report. “K202836: GX Navigation Instrument System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K202836

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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