510(k) Report

510(k) · Cleared

Cleared

SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments

K260571510(k) TraditionalCleared Jun 2, 2026103-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 Jun 2, 2026 as substantially equivalent to K252088 (Orthofix US, LLC, 2025) and 7 other predicates after a 103-day review. Its family tree reaches back 23 generations to 2004. 3 of the 705 devices in its family, counting itself, have a Class I recall.

Decided
Jun 2, 2026
Review
103 days
Class
Class II
Product code
OLO
Recalls
None
Predicates
8

Its longest line of descent runs back 23 generations to K040583 (2004). 704 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 3 of the 705 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year cleared 2025: 2 other ancestors2021: 3 other ancestors2020: 7 other ancestors2018: 6 other ancestors2016: 11 other ancestors, 1 with a Class I recall12015: 24 other ancestors, 1 with a Class I recall12017: 7 other ancestors2014: 12 other ancestors2013: 18 other ancestors2012: 19 other ancestors2011: 28 other ancestors2019: 2 other ancestors2010: 28 other ancestors, 1 with a Class I recall12009: 28 other ancestors2008: 39 other ancestors2007: 30 other ancestors2006: 37 other ancestors2005: 45 other ancestors2002: 37 other ancestors1996: 14 other ancestors1991: 2 other ancestors2004: 58 other ancestors2003: 36 other ancestors2001: 41 other ancestors2000: 33 other ancestors1999: 21 other ancestors1997: 16 other ancestors1995: 18 other ancestors1994: 8 other ancestors1990: 4 other ancestors1998: 24 other ancestors1993: 5 other ancestors1988: 2 other ancestors1987: 1 other ancestor1992: 7 other ancestors1989: 1 other ancestor1986: 2 other ancestors1985: 2 other ancestors1984: 2 other ancestors1978: 1 other ancestor×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. · 2020K202836 · GX Navigation Instrument System · Life Spine, Inc. · 202119801990200020102020
Other ancestors, by generation 1 generation back: 7 other ancestors2 generations back: 16 other ancestors3 generations back: 46 other ancestors4 generations back: 67 other ancestors, 1 with a Class I recall15 generations back: 119 other ancestors, 2 with a Class I recall26 generations back: 154 other ancestors7 generations back: 116 other ancestors8 generations back: 83 other ancestors9 generations back: 42 other ancestors10 generations back: 13 other ancestors11 generations back: 10 other ancestors12 generations back: 4 other ancestors13 generations back: 3 other ancestors14 generations back: 1 other ancestor K202836 · GX Navigation Instrument System · Life Spine, Inc. · 2021K200070 · 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 · 23 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 19 generations between
  3. 3 generations backK191575 ARx Spinal SystemLife Spine, Inc. · 2019
  4. 2 generations backK200070 ARx Spinal SystemLife Spine, Inc. · 2020
  5. 1 generation backK202836 GX Navigation Instrument SystemLife Spine, Inc. · 2021
  6. This deviceK260571 SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc. · 2026
Show all 23 generations
  1. Root · 23 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 22 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 21 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 20 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 19 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 18 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 17 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 16 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 15 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 14 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 13 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 12 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 11 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 10 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  15. 9 generations backK132111 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  16. 8 generations backK141604 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
  17. 7 generations backK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
  18. 6 generations backK160989 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
  19. 5 generations backK170126 NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated · 2017
  20. 4 generations backK182974 NuVasive Reline SystemNu Vasive, Incorporated · 2019
  21. 3 generations backK191575 ARx Spinal SystemLife Spine, Inc. · 2019
  22. 2 generations backK200070 ARx Spinal SystemLife Spine, Inc. · 2020
  23. 1 generation backK202836 GX Navigation Instrument SystemLife Spine, Inc. · 2021
  24. This deviceK260571 SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc. · 2026

Class I recalls in this family

  • K153660 StealthStation System with Cranial Software4 generations back · 2016
  • K150216 Synergy Cranial5 generations back · 2015
  • K100952 Modification to Synthes Matrix System5 generations back · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−23K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−22K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−21K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−20K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−19K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−18K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−17K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−16K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−15K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−14K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−13K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−12K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−11K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−10K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013—
−9K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013—
−8K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014—
−7K143684NuVasive Reline SystemNu Vasive, Incorporated2015—
−6K160989NuVasive® Reline® SystemNu Vasive, Incorporated2016—
−5K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated2017—
−4K182974NuVasive Reline SystemNu Vasive, Incorporated2019—
−3K191575ARx Spinal SystemLife Spine, Inc.2019—
−2K200070ARx Spinal SystemLife Spine, Inc.2020—
−1K202836GX Navigation Instrument SystemLife Spine, Inc.2021—
0 (this device)K260571SIMPACT 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
199040
199120
199270
199350
199480
1995180
1996140
1997160
1998240
1999210
2000330
2001410
2002370
2003360
2004580
2005450
2006370
2007300
2008390
2009280
2010281
2011280
2012190
2013180
2014120
2015241
2016111
201770
201860
201920
202070
202130
202520
FIG. 1 — Lineage of K260571, 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.

3 devices in this family have 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? (8)

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
*K252088Firebird SI Navigation System
Summary page 5
…n Name: Sacroiliac Joint Fixation Classification: OLO, CFR 882.4560, Class II Primary Predicate: Orthofix Firebird SI Navigation System K252088 Additional Predicates: Medtronic Rialto Navigation K251395 & K161210 Life Spine GX Navigation Ins…
Orthofix US, LLC2025—
*K251395The Rialto™ SI Fusion System
Summary page 5
…OLO, CFR 882.4560, Class II Primary Predicate: Orthofix Firebird SI Navigation System K252088 Additional Predicates: Medtronic Rialto Navigation K251395 & K161210 Life Spine GX Navigation Instruments K202836 Life Spine Simpact S…
Medtronic Sofamor Danek USA, Inc.2025—
*K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…
Summary page 5
…OLO, CFR 882.4560, Class II Primary Predicate: Orthofix Firebird SI Navigation System K252088 Additional Predicates: Medtronic Rialto Navigation K251395 & K161210 Life Spine GX Navigation Instruments K202836 Life Spine Simpact Sacroiliac…
Medtronic Sofamor Danek2016—
*K202836GX Navigation Instrument System
Summary page 5
…rd SI Navigation System K252088 Additional Predicates: Medtronic Rialto Navigation K251395 & K161210 Life Spine GX Navigation Instruments K202836 Life Spine Simpact Sacroiliac Joint Fixation System K212903, K201538, K1807…
Life Spine, Inc.2021—
*K212903SIMPACT Sacroiliac Joint Fixation System
Summary page 5
…K251395 & K161210 Life Spine GX Navigation Instruments K202836 Life Spine Simpact Sacroiliac Joint Fixation System K212903, K201538, K180749 & K141246 Device Description: The SIMPACT Sacroiliac Joint Fixation System GX Nav…
Life Spine, Inc.2021—
*K201538Life Spine SIMPACT Sacroiliac Joint Fixation System
Summary page 5
…& K161210 Life Spine GX Navigation Instruments K202836 Life Spine Simpact Sacroiliac Joint Fixation System K212903, K201538, K180749 & K141246 Device Description: The SIMPACT Sacroiliac Joint Fixation System GX Navigation I…
Life Spine, Inc.2020—
*K180749Life Spine SIMPACT Sacroiliac Joint Fixation System
Summary page 5
…Life Spine GX Navigation Instruments K202836 Life Spine Simpact Sacroiliac Joint Fixation System K212903, K201538, K180749 & K141246 Device Description: The SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments are manufactured from Sta…
Life Spine, Inc.2018—
*K141246Life Spine Sacroiliac Joint Fixation System
Summary page 5
…e GX Navigation Instruments K202836 Life Spine Simpact Sacroiliac Joint Fixation System K212903, K201538, K180749 & K141246 Device Description: The SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments are manufactured from Stainless Ste…
Life Spine, Inc.2015—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (3 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.

  • K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 4 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
  • K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 5 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
  • K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 5 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 7 months on median.
  • 92 of the 704 ancestors have a recall of any class; 3 have a Class I recall.

How does its category compare?

All OLO devices

OLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments are intended to be used during the preparation and placement of the SIMPACT Sacroiliac Joint Fixation System 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® S7 System, which is indicated for any medical condition in which…

Read the full statement (107 words)

The SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments are intended to be used during the preparation and placement of the SIMPACT Sacroiliac Joint Fixation System 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® S7 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 the pelvis 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.

More from Life Spine, Inc.

85 FDA decisions under this applicant name. See the company

  • K261430TruLift Expandable SystemLife 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
  • K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc. · 2025

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/K260571 · printed Nov 6, 2026

Cite this page

510(k) Report. “K260571: SIMPACT Sacroiliac Joint Fixation System GX 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/K260571

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Record history
  • FDA decision record loaded Oct 30, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026