510(k) Report

510(k) · Cleared

Cleared

Life Spine SIMPACT Sacroiliac Joint Fixation System

K201538510(k) TraditionalCleared Sep 18, 2020101-day reviewClass II21 CFR 888.3040

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

Life Spine, Inc. · OUR Sacroiliac Joint Fixation

Cleared on Sep 18, 2020 as substantially equivalent to K141246 (Life Spine, Inc., 2015) and 3 other predicates after a 101-day review. Its family tree reaches back 16 generations to 1993. 13 later devices descend from it.

Decided
Sep 18, 2020
Review
101 days
Class
Class II
Product code
OUR
Recalls
None
Predicates
4

Its longest line of descent runs back 16 generations to K930834 (1993). 36 ancestors in all, the oldest K903810 (1990). 13 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2018: 1 other ancestor2015: 3 other ancestors2013: 1 other ancestor2011: 3 other ancestors2010: 2 other ancestors2009: 1 other ancestor2002: 2 other ancestors2005: 1 other ancestor2001: 2 other ancestors1996: 1 other ancestor2000: 1 other ancestor1990: 1 other ancestor1995: 1 other ancestor2024: 2 descendants cleared2026: 3 descendants cleared2021: 2 descendants cleared2023: 5 descendants cleared2025: 1 descendant clearedK930834 · Acutract · Acu Med, Inc. · 1993K051309 · Roi Fusion Rods & Plates · Reiley Orthopaedics, Inc. · 2005 · recalledK080398 · SI Joint Fusion System · SI-BONE, Inc. · 2008K110838 · Ifuse Implant System · SI-BONE, Inc. · 2011K122074 · Ifuse Implant System · SI-BONE, Inc. · 2012K123850 · Ifuse Implant System · SI-BONE, Inc. · 2013K131405 · Ifuse Implant System · SI-BONE, Inc. · 2013K141049 · Ifuse Implant System · SI-BONE, Inc. · 2014K150714 · SI-BONE iFuse Implant System · SI-BONE, Inc. · 2015×3: 3 generations cleared close together, K151718 (2015), K152681 (2016), K160652 (2016) K162733 · iFuse Implant System® - iFuse-3D implant · SI-BONE, Inc. · 2017×2: 2 generations cleared close together, K182983 (2018), K190230 (2019) K193524 · SI-BONE iFuse Implant System® · SI-BONE, Inc. · 20201990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 5 other ancestors3 generations back: 5 other ancestors4 generations back: 4 other ancestors5 generations back: 2 other ancestors6 generations back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 3 descendants3 generations forward: 3 descendants4 generations forward: 2 descendants K193524 · SI-BONE iFuse Implant System® · SI-BONE, Inc. · 2020K190230 · iFuse Implant System® · SI-BONE, Inc. · 2019K182983 · iFuse Implant System® · SI-BONE, Inc. · 2018K162733 · iFuse Implant System® - iFuse-3D implant · SI-BONE, Inc. · 2017K160652 · iFUSE Implant System · SI-BONE, Inc. · 2016K152681 · iFuse Implant System (R) · SI-BONE, Inc. · 2016K151718 · iFuse Implant System · SI-BONE, Inc. · 2015K150714 · SI-BONE iFuse Implant System · SI-BONE, Inc. · 2015K141049 · Ifuse Implant System · SI-BONE, Inc. · 2014K131405 · Ifuse Implant System · SI-BONE, Inc. · 2013K123850 · Ifuse Implant System · SI-BONE, Inc. · 2013K122074 · Ifuse Implant System · SI-BONE, Inc. · 2012K110838 · Ifuse Implant System · SI-BONE, Inc. · 2011K080398 · SI Joint Fusion System · SI-BONE, Inc. · 2008K051309 · Roi Fusion Rods & Plates · Reiley Orthopaedics, Inc. · 2005 · recalledK930834 · Acutract · Acu Med, Inc. · 1993−15−10−50
  1. Root · 16 generations backK930834 AcutractAcu Med, Inc. · 1993
  2. 12 generations between
  3. 3 generations backK182983 iFuse Implant System®SI-BONE, Inc. · 2018
  4. 2 generations backK190230 iFuse Implant System®SI-BONE, Inc. · 2019
  5. 1 generation backK193524 SI-BONE iFuse Implant System®SI-BONE, Inc. · 2020
  6. This deviceK201538 Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc. · 2020
  7. Descendant · cites it directly · 8 of its ownK212903 SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc. · 2021
  8. Descendant · 2 generations on · 3 of its ownK223708 Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC · 2023
  9. Descendant · 2 generations on · 2 of its ownK223819 SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC · 2023
  10. Descendant · cites it directly · 1 of its ownK241464 ARx® SAI Implant SystemLife Spine, Inc. · 2024
  11. Descendant · 3 generations on · 1 of its ownK240505 Eminent Spine SI Screw SystemEminent Spine, LLC · 2024
Show all 16 generations
  1. Root · 16 generations backK930834 AcutractAcu Med, Inc. · 1993
  2. 15 generations backK051309 Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 2005 · Recalled
  3. 14 generations backK080398 SI Joint Fusion SystemSI-BONE, Inc. · 2008
  4. 13 generations backK110838 Ifuse Implant SystemSI-BONE, Inc. · 2011
  5. 12 generations backK122074 Ifuse Implant SystemSI-BONE, Inc. · 2012
  6. 11 generations backK123850 Ifuse Implant SystemSI-BONE, Inc. · 2013
  7. 10 generations backK131405 Ifuse Implant SystemSI-BONE, Inc. · 2013
  8. 9 generations backK141049 Ifuse Implant SystemSI-BONE, Inc. · 2014
  9. 8 generations backK150714 SI-BONE iFuse Implant SystemSI-BONE, Inc. · 2015
  10. 7 generations backK151718 iFuse Implant SystemSI-BONE, Inc. · 2015
  11. 6 generations backK152681 iFuse Implant System (R)SI-BONE, Inc. · 2016
  12. 5 generations backK160652 iFUSE Implant SystemSI-BONE, Inc. · 2016
  13. 4 generations backK162733 iFuse Implant System® - iFuse-3D implantSI-BONE, Inc. · 2017
  14. 3 generations backK182983 iFuse Implant System®SI-BONE, Inc. · 2018
  15. 2 generations backK190230 iFuse Implant System®SI-BONE, Inc. · 2019
  16. 1 generation backK193524 SI-BONE iFuse Implant System®SI-BONE, Inc. · 2020
  17. This deviceK201538 Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc. · 2020

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2021: 22023: 52024: 22025: 12026: 3
2021high 5 (2023) · low 0 (2022)2026

Most influential descendants

Showing 5 of 13 · See all
  • K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc. · 2021 · cites it directly8descendants
  • K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC · 2023 · 2 generations on3descendants
  • K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC · 2023 · 2 generations on2descendants
  • K241464ARx® SAI Implant SystemLife Spine, Inc. · 2024 · cites it directly1descendant
  • K240505Eminent Spine SI Screw SystemEminent Spine, LLC · 2024 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−16K930834AcutractAcu Med, Inc.1993—
−15K051309Roi Fusion Rods & PlatesReiley Orthopaedics, Inc.20052
−14K080398SI Joint Fusion SystemSI-BONE, Inc.2008—
−13K110838Ifuse Implant SystemSI-BONE, Inc.2011—
−12K122074Ifuse Implant SystemSI-BONE, Inc.2012—
−11K123850Ifuse Implant SystemSI-BONE, Inc.2013—
−10K131405Ifuse Implant SystemSI-BONE, Inc.2013—
−9K141049Ifuse Implant SystemSI-BONE, Inc.2014—
−8K150714SI-BONE iFuse Implant SystemSI-BONE, Inc.2015—
−7K151718iFuse Implant SystemSI-BONE, Inc.2015—
−6K152681iFuse Implant System (R)SI-BONE, Inc.2016—
−5K160652iFUSE Implant SystemSI-BONE, Inc.2016—
−4K162733iFuse Implant System® - iFuse-3D implantSI-BONE, Inc.2017—
−3K182983iFuse Implant System®SI-BONE, Inc.2018—
−2K190230iFuse Implant System®SI-BONE, Inc.2019—
−1K193524SI-BONE iFuse Implant System®SI-BONE, Inc.2020—
0 (this device)K201538Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.2020—
+1K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.2021—
+2K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC2023—
+2K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC2023—
+1K241464ARx® SAI Implant SystemLife Spine, Inc.2024—
+3K240505Eminent Spine SI Screw SystemEminent Spine, LLC2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199510
199610
200010
200120
200220
200510
200910
201020
201130
201310
201530
201810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202120
202350
202420
202510
202630
FIG. 1 — Lineage of K201538, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

Planning a device in OUR? 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 OUR device

  1. #1 K233508 iFuse Bedrock Granite® Implant Systemscore 30.7 · 31 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K141246Life Spine Sacroiliac Joint Fixation System
Summary page 4
…: HWC, CFR 888.3040, Class II OUR, CFR 888.3040, Class II Primary Predicate: Life Spine Sacroiliac Joint Fixation Screw System (K141246) Additional Predicates: Life Spine Sacroiliac Joint Fixation Screw System (K180749) Zyga Tech. Si…
Life Spine, Inc.2015—
*K180749Life Spine SIMPACT Sacroiliac Joint Fixation System
Summary page 4
…II Primary Predicate: Life Spine Sacroiliac Joint Fixation Screw System (K141246) Additional Predicates: Life Spine Sacroiliac Joint Fixation Screw System (K180749) Zyga Tech. Simmetry Sacroiliac Joint Fixation Screw System (K141549) Si-Bo…
Life Spine, Inc.2018—
*K141549SImmetry Sacroiliac Joint Fusion System
Summary page 4
…tional Predicates: Life Spine Sacroiliac Joint Fixation Screw System (K180749) Zyga Tech. Simmetry Sacroiliac Joint Fixation Screw System (K141549) Si-Bone iFuse Implant System (K193524) Device Description: The Life Spine SIMPACT Sacroiliac Join…
Zyga Technology, Inc.2015—
*K193524SI-BONE iFuse Implant System®
Summary page 4
…System (K180749) Zyga Tech. Simmetry Sacroiliac Joint Fixation Screw System (K141549) Si-Bone iFuse Implant System (K193524) Device Description: The Life Spine SIMPACT Sacroiliac Joint Fixation System consists of fully threaded screws and partially…
SI-BONE, Inc.2020—

Also cleared against K141246: 6 other devices →

What descends from it? (13)

See all 13

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218
K241464ARx® SAI Implant SystemLife Spine, Inc.20241
K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260
K253611Falco Fusion SystemMcnicoll Surgical, Inc.20260
K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 9 months on median.
  • 4 of the 36 ancestors have a recall of any class.
  • Of its descendants, K212903 (Life Spine, Inc., 2021) has gone furthest, with 8 descendants of its own.
  • 6 other devices also cite its predicate K141246.

How does its category compare?

All OUR devices

OUR Sacroiliac Joint Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.

FDA decisions per year · OUR

14in 2025

2008: 12009: 12010: 12011: 32012: 22013: 42014: 32015: 82016: 62017: 42018: 72019: 72020: 72021: 92022: 142023: 202024: 152025: 142026 (partial year): 6
2007high 20 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OUR

97in 2025

2011: 27 days median2013: 103 days median2014: 91 days median2015: 111 days median2016: 168 days median2017: 120 days median2018: 82 days median2019: 89 days median2020: 88 days median2021: 85 days median2022: 149 days median2023: 55 days median2024: 74 days median2025: 97 days median2026 (partial year): 98 days median
2007high 168 (2016) · low 27 (2011)2026

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

Recalls per year · OUR

1in 2025

2025: 12026 (partial year): 1
2007high 1 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OUR

10in 2025

2011: 62012: 812013: 962014: 1462015: 1192016: 1222017: 1572018: 1372019: 1752020: 1482021: 1542022: 232023: 72024: 152025: 10
2007high 175 (2019) · low 0 (2007)2025

MAUDE reports naming product code OUR, 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
20081—00
20091—00
20101—00
201132706
20122—081
20134103096
20143910146
201581110119
201661680122
201741200157
20187820137
20197890175
20207880148
20219850154
202214149023
2023205507
20241574015
20251497110
20266981—

What is it indicated for?

The Life Spine SIMPACT Sacroiliac Joint Fixation System is intended for sacroiliac fusion for the following conditions:

• Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.

• To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

• Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

Indications for use as stated in the FDA summary.

Also cleared against K141246

6 other devices cite the same predicate.

  • K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc. · 2026
  • K254274ARx® SAI Implant SystemLife Spine, Inc. · 2026
  • K241464ARx® SAI Implant SystemLife Spine, Inc. · 2024
  • K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc. · 2021
  • K180749Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc. · 2018
  • K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd. · 2016

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 OUR

The OUR category page

  • K262522Odys-SI ScrewMedyssey Co, Ltd. · 2026
  • K261381TiLink-L™ SI Joint Fusion SystemSurGenTec, LLC · 2026
  • K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical · 2026
  • K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc. · 2026
  • K253611Falco Fusion SystemMcnicoll Surgical, Inc. · 2026

https://510kreport.com/device/K201538 · printed Nov 6, 2026

Cite this page

510(k) Report. “K201538: Life Spine SIMPACT Sacroiliac Joint Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201538

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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