510(k) Report

510(k) · Cleared

Cleared

Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion Cervical

K161710510(k) TraditionalCleared Jun 29, 2017373-day reviewClass II21 CFR 888.3080

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

Spinal Analytics & Geometrical Impant Co, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Jun 29, 2017 as substantially equivalent to K102293 (Globus Medical, Inc., 2011) and 3 other predicates after a 373-day review. Its family tree reaches back 12 generations to 1984. 41 later devices descend from it.

Decided
Jun 29, 2017
Review
373 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
4

Its longest line of descent runs back 12 generations to K841189 (1984). 49 ancestors in all. 41 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 1 other ancestor2008: 3 other ancestors2014: 1 other ancestor2009: 2 other ancestors2013: 1 other ancestor2007: 2 other ancestors2002: 5 other ancestors2001: 10 other ancestors2005: 2 other ancestors2004: 4 other ancestors2000: 1 other ancestor2003: 4 other ancestors1999: 1 other ancestor2018: 1 descendant cleared2023: 6 descendants cleared2019: 1 descendant cleared2025: 11 descendants cleared2026: 12 descendants cleared2020: 1 descendant cleared2022: 1 descendant cleared2021: 1 descendant cleared2024: 7 descendants clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) K033109 · Ellys and Aurys Vertebral Body Replacements · Scient'X · 2004K043479 · MC+ Partial VBR · Ldr Spine USA · 2005K080728 · LDR Spine Roi-C Implant · Ldr Spine USA · 2008×2: 2 generations cleared close together, K083857 (2009), K091088 (2009) K113559 · LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants · Ldr Spine USA, Inc. · 2011K150765 · LDR Spine ROI-C Cervical Cage System · Ldr Spine USA · 201519801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors3 generations back: 5 other ancestors4 generations back: 9 other ancestors5 generations back: 9 other ancestors6 generations back: 7 other ancestors7 generations back: 2 other ancestors 1 generation forward: 4 descendants2 generations forward: 1 descendant3 generations forward: 12 descendants4 generations forward: 12 descendants5 generations forward: 7 descendants6 generations forward: 3 descendants7 generations forward: 1 descendant8 generations forward: 1 descendant K150765 · LDR Spine ROI-C Cervical Cage System · Ldr Spine USA · 2015K113559 · LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants · Ldr Spine USA, Inc. · 2011K091088 · LDR Spine Cervical Interbody Fusion System · Ldr Spine USA · 2009K083857 · LDR Spine Roi-C Implant · Ldr Spine USA · 2009K080728 · LDR Spine Roi-C Implant · Ldr Spine USA · 2008K043479 · MC+ Partial VBR · Ldr Spine USA · 2005K033109 · Ellys and Aurys Vertebral Body Replacements · Scient'X · 2004K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−10−50+5
  1. Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 8 generations between
  3. 3 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
  4. 2 generations backK113559 LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsLdr Spine USA, Inc. · 2011
  5. 1 generation backK150765 LDR Spine ROI-C Cervical Cage SystemLdr Spine USA · 2015
  6. This deviceK161710 Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC · 2017
  7. Descendant · cites it directly · 37 of its ownK180909 REVEL SpacersGlobus Medical, Inc. · 2018
  8. Descendant · 2 generations on · 36 of its ownK191243 HEDRON Cervical SpacersGlobus Medical, Inc. · 2019
  9. Descendant · 3 generations on · 23 of its ownK222270 HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable…Globus Medical, Inc. · 2022
  10. Descendant · 4 generations on · 6 of its ownK241846 E3D™-C Interbody SystemEvolution Spine · 2024
  11. Descendant · 4 generations on · 5 of its ownK243635 aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc. · 2024
Show all 12 generations
  1. Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 11 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 10 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 9 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 8 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 7 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
  7. 6 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
  8. 5 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
  9. 4 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
  10. 3 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
  11. 2 generations backK113559 LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsLdr Spine USA, Inc. · 2011
  12. 1 generation backK150765 LDR Spine ROI-C Cervical Cage SystemLdr Spine USA · 2015
  13. This deviceK161710 Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC · 2017

Showing 5 of 41 descendants. See all descendants

Descendants cleared per year

2018: 12019: 12020: 12021: 12022: 12023: 62024: 72025: 112026: 12
2018high 12 (2026) · low 1 (2018)2026

Most influential descendants

Showing 5 of 41 · See all
  • K180909REVEL SpacersGlobus Medical, Inc. · 2018 · cites it directly37descendants
  • K191243HEDRON Cervical SpacersGlobus Medical, Inc. · 2019 · 2 generations on36descendants
  • K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc. · 2022 · 3 generations on23descendants
  • K241846E3D™-C Interbody SystemEvolution Spine · 2024 · 4 generations on6descendants
  • K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc. · 2024 · 4 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−11K990148Stackable Cage SystemDepuy Motech Acromed1999—
−10K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−9K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−8K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−7K033109Ellys and Aurys Vertebral Body ReplacementsScient'X2004—
−6K043479MC+ Partial VBRLdr Spine USA2005—
−5K080728LDR Spine Roi-C ImplantLdr Spine USA2008—
−4K083857LDR Spine Roi-C ImplantLdr Spine USA2009—
−3K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA2009—
−2K113559LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsLdr Spine USA, Inc.2011—
−1K150765LDR Spine ROI-C Cervical Cage SystemLdr Spine USA2015—
0 (this device)K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC2017—
+1K180909REVEL SpacersGlobus Medical, Inc.2018—
+2K191243HEDRON Cervical SpacersGlobus Medical, Inc.2019—
+3K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer…Globus Medical, Inc.2022—
+4K241846E3D™-C Interbody SystemEvolution Spine2024—
+4K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200010
2001100
200250
200340
200440
200520
200720
200830
200920
201110
201310
201410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
201910
202010
202110
202210
202360
202470
2025110
2026120
FIG. 1 — Lineage of K161710, 1984–2026Source: 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.

Planning a device in MAX? 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 MAX device

  1. #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 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
*K102293Caliber Spacer
Summary page 5
…Product Code Caliber Spacer Globus Medical, Inc Primary MAX K102293 PATRIOT Lumbar Spacers Globus Medical, Inc Additional MAX K072970 LDR Spine ROI…
Globus Medical, Inc.2011—
*K072970Patriot Spacers
Summary page 5
…Medical, Inc Primary MAX K102293 PATRIOT Lumbar Spacers Globus Medical, Inc Additional MAX K072970 LDR Spine ROI-C Cervical Cage System LDR Spine USA Additional OVE K150765 Valeo Spacer…
Globus Medical, Inc.2008—
*K150765LDR Spine ROI-C Cervical Cage System
Summary page 5
…Medical, Inc Additional MAX K072970 LDR Spine ROI-C Cervical Cage System LDR Spine USA Additional OVE K150765 Valeo Spacer System Amedica Corporation Additional OVE K113559 These pr…
Ldr Spine USA2015—
*K113559LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants
Summary page 5
…ine USA Additional OVE K150765 Valeo Spacer System Amedica Corporation Additional OVE K113559 These predicate devices are cleared and legally marketed, distributed for similar indications, and/or have similar desig…
Ldr Spine USA, Inc.2011—

Also cleared against K102293: 30 other devices →

What descends from it? (41)

See all 41

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

NumberDeviceApplicantDecidedDescendants
K180909REVEL SpacersGlobus Medical, Inc.201837
K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231
K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230
K223143SAGICO Spinal SystemSagico VA USA, LLC20230

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 33 years and passes through 8 companies; a new generation was cleared every 1.8 years on median.
  • 4 of the 49 ancestors have a recall of any class.
  • Of its descendants, K180909 (Globus Medical, Inc., 2018) has gone furthest, with 37 descendants of its own.
  • 30 other devices also cite its predicate K102293.

How does its category compare?

All MAX devices

MAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · MAX

29in 2025

2007: 72008: 352009: 312010: 292011: 492012: 482013: 582014: 582015: 532016: 642017: 762018: 642019: 602020: 562021: 532022: 412023: 302024: 382025: 292026 (partial year): 18
2007high 76 (2017) · low 7 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAX

85in 2025

2007: 86 days median2008: 88 days median2009: 102 days median2010: 137 days median2011: 98 days median2012: 69 days median2013: 102 days median2014: 115 days median2015: 113 days median2016: 124 days median2017: 116 days median2018: 114 days median2019: 131 days median2020: 106 days median2021: 109 days median2022: 95 days median2023: 87 days median2024: 91 days median2025: 85 days median2026 (partial year): 95 days median
2007high 137 (2010) · low 69 (2012)2026

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

Recalls per year · MAX

5in 2025

2008: 22009: 92011: 32012: 11, 1 Class I2014: 32015: 12016: 62017: 12018: 42019: 12022: 12024: 12025: 5
2007high 11 (2012) · low 0 (2007)2026

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

Adverse event reports per year · MAX

811in 2025

2007: 122008: 192009: 902010: 1542011: 2012012: 3272013: 3802014: 3662015: 5242016: 6472017: 5962018: 6162019: 6992020: 6402021: 6222022: 6182023: 5762024: 7292025: 811
2007high 811 (2025) · low 12 (2007)2025

MAUDE reports naming product code MAX, 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
2007786012
20083588219
200931102990
2010291370154
201149983201
2012486911 (1)327
2013581020380
2014581153366
2015531131524
2016641246647
2017761161596
2018641144616
2019601311699
2020561060640
2021531090622
202241951618
202330870576
202438911729
202529855811
202618950—

What is it indicated for?

SAGICO IBF System - ARIA Lumbar implants are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may…

Read the full statement (250 words)

SAGICO IBF System - ARIA Lumbar implants are interbody fusion devices intended for use in patients with

degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as

discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients

should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients

may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

SAGICO IBF System - ARIA Lumbar are to be filled with autogenous bone graft material. The SAGICO IBF System -

ARIA Lumbar implant is intended to be used with supplemental fixation cleared by the FDA to properly utilize this

device.

The SAGICO IBF System – ARION Cervical implant is interbody fusion device intended for use in skeletally mature

patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one

disc level from (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and

radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative

treatment.

The SAGICO IBF System – ARION Cervical implant is to be filled with autogenous bone graft material and placed

via open anterior approach. The SAGICO IBF System – ARION Cervical implant must be used with additional

internal fixation (e.g. anterior plate or cervical pedicle screws) cleared by the FDA to properly utilize this device.

Indications for use as stated in the FDA summary.

Also cleared against K102293

30 other devices cite the same predicate.

  • K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc. · 2023
  • K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated · 2021
  • K191391HEDRON Lumbar SpacersGlobus Medical, Inc. · 2019
  • K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019
  • K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC · 2019
  • K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc. · 2019

Recent decisions in MAX

The MAX category page

  • K262646Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX…Alphatec Spine, Inc. · 2026
  • K261049Scala® TLSpineart SA · 2026
  • K261430TruLift Expandable SystemLife Spine, Inc. · 2026
  • K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2026
  • K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2026

https://510kreport.com/device/K161710 · printed Nov 6, 2026

Cite this page

510(k) Report. “K161710: Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion Cervical.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161710

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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