510(k) Report

510(k) · Cleared

Cleared

MONDRIAN Lumbar Interbody Fusion Cage System

K192863510(k) TraditionalCleared Aug 26, 2020324-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

Ctl Medical Corporation · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Aug 26, 2020 as substantially equivalent to K121567 (Accel Spine, 2012) and 9 other predicates after a 324-day review. Its family tree reaches back 21 generations to 1984. 3 later devices descend from it.

Decided
Aug 26, 2020
Review
324 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
10

Its longest line of descent runs back 21 generations to K841189 (1984). 245 ancestors in all. 3 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2016: 4 other ancestors2015: 6 other ancestors2014: 10 other ancestors2013: 11 other ancestors2012: 11 other ancestors2010: 15 other ancestors2008: 35 other ancestors2011: 17 other ancestors2009: 20 other ancestors2007: 12 other ancestors2005: 15 other ancestors1999: 2 other ancestors1996: 2 other ancestors2006: 8 other ancestors2004: 21 other ancestors2003: 14 other ancestors2002: 9 other ancestors2001: 10 other ancestors2000: 2 other ancestors2022: 1 descendant cleared2023: 1 descendant cleared2024: 1 descendant 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) ×2: 2 generations cleared close together, K041888 (2004), K042930 (2004) K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K073291 · Capstone Spinal System · Medtronic Sofamor Danek USA, Inc. · 2008K094025 · Crescent Spinal System · Medtronic Sofamor Danek · 2010K110543 · Crescent (R) Spinal System Titanium · Medtronic Sofamor Danek USA, Inc. · 2011K121683 · Acculif TL Cage · Coalign Innovations, Inc. · 2012K123752 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013K132505 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013 · recalledK141217 · Acculif TL and PL Cage · Stryker Corporation · 2014 · recalledK143163 · AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System · Stryker Corporation · 2015×2: 2 generations cleared close together, K153782 (2016), K161230 (2016) ×2: 2 generations cleared close together, K170962 (2017), K171633 (2017) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 9 other ancestors2 generations back: 30 other ancestors3 generations back: 40 other ancestors4 generations back: 50 other ancestors5 generations back: 43 other ancestors6 generations back: 28 other ancestors7 generations back: 16 other ancestors8 generations back: 7 other ancestors9 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 1 descendant K171633 · NuVasive TLX Interbody System · Nu Vasive, Incorporated · 2017K170962 · NuVasive® CoRoent® Thoracolumbar System · Nu Vasive, Incorporated · 2017K161230 · NuVasive Lumbar Interbody Implants · Nu Vasive, Incorporated · 2016K153782 · NuVasive® Lumbar Interbody Implants · Nu Vasive, Incorporated · 2016K143163 · AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System · Stryker Corporation · 2015K141217 · Acculif TL and PL Cage · Stryker Corporation · 2014 · recalledK132505 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013 · recalledK123752 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013K121683 · Acculif TL Cage · Coalign Innovations, Inc. · 2012K110543 · Crescent (R) Spinal System Titanium · Medtronic Sofamor Danek USA, Inc. · 2011K094025 · Crescent Spinal System · Medtronic Sofamor Danek · 2010K073291 · Capstone Spinal System · Medtronic Sofamor Danek USA, Inc. · 2008K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K042930 · Spacevision Cage System · Spine Vision, Inc. · 2004K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 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. · 1984−20−15−10−50
  1. Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 17 generations between
  3. 3 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
  4. 2 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
  5. 1 generation backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
  6. This deviceK192863 MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation · 2020
  7. Descendant · cites it directly · 1 of its ownK213641 MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation · 2022
  8. Descendant · 2 generations on · 0 of its ownK231715 MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation · 2024
  9. Descendant · cites it directly · 0 of its ownK220513 NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation · 2023
Show all 21 generations
  1. Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 20 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 19 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 18 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 17 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 16 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 15 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 14 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 13 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 12 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
  11. 11 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
  12. 10 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
  13. 9 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
  14. 8 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
  15. 7 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
  16. 6 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
  17. 5 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
  18. 4 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
  19. 3 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
  20. 2 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
  21. 1 generation backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
  22. This deviceK192863 MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation · 2020

Most influential descendants

Showing 3 of 3 · See all
  • K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation · 2022 · cites it directly1descendant
  • K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation · 2024 · 2 generations on0descendants
  • K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation · 2023 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−21K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−20K990148Stackable Cage SystemDepuy Motech Acromed1999—
−19K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−18K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−17K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−16K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−15K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−14K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−13K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−12K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008—
−11K094025Crescent Spinal SystemMedtronic Sofamor Danek2010—
−10K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011—
−9K121683Acculif TL CageCoalign Innovations, Inc.2012—
−8K123752Acculif TL and PL CageCoalign Innovations, Inc.2013—
−7K132505Acculif TL and PL CageCoalign Innovations, Inc.20133
−6K141217Acculif TL and PL CageStryker Corporation20143
−5K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK…Stryker Corporation2015—
−4K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016—
−3K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016—
−2K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017—
−1K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017—
0 (this device)K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation2020—
+1K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation2022—
+2K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation2024—
+1K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
199920
200020
2001100
200290
2003140
2004210
2005150
200680
2007120
2008350
2009200
2010150
2011170
2012110
2013110
2014100
201560
201640

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202210
202310
202410
FIG. 1 — Lineage of K192863, 1984–2024Source: 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? (10)

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
*K121567Oracle Lumbar Intervertebral Body Fusion Cage System
Summary page 5
…K192863 - Page 2 of 4 Predicate Device Primary Predicate Device • CEZANNE Lumbar Interbody Fusion Cage System, K121567 Additional Predicate Devices • CEZANNE-II Lumbar Interbody Fusion Cage System, K131981…
Accel Spine2012—
*K131981Cezanne II Interbody Fusion System
Summary page 5
…umbar Interbody Fusion Cage System, K121567 Additional Predicate Devices • CEZANNE-II Lumbar Interbody Fusion Cage System, K131981 • PHANTOM PLUS Cage System, K082801 • VALEO Spacer System…
Accel Spine20134
*K082801Phantom Plus Cage System
Summary page 5
…Predicate Devices • CEZANNE-II Lumbar Interbody Fusion Cage System, K131981 • PHANTOM PLUS Cage System, K082801 • VALEO Spacer System K091278, K142347, K143518 • VALEO-II IBF Device…
Us Spine2008—
*K091278Valeo Spacer System
Summary page 5
…e System, K131981 • PHANTOM PLUS Cage System, K082801 • VALEO Spacer System K091278, K142347, K143518 • VALEO-II IBF Device System K121892, K142347, K143518 • V…
Amedica Corp.2010—
*K142347Amedica Valeo II Interbody Fusion Device
Summary page 5
…K131981 • PHANTOM PLUS Cage System, K082801 • VALEO Spacer System K091278, K142347, K143518 • VALEO-II IBF Device System K121892, K142347, K143518 • VALEO-II I…
Amedica Corp.2014—
*K143518Valeo Spacer System and Valeo II Interbody Fusion Device System
Summary page 5
…31981 • PHANTOM PLUS Cage System, K082801 • VALEO Spacer System K091278, K142347, K143518 • VALEO-II IBF Device System K121892, K142347, K143518 • VALEO-II IBF Device…
Amedica Corp.2015—
*K121892Phantom Plus Ceramic Cage System
Summary page 5
…K082801 • VALEO Spacer System K091278, K142347, K143518 • VALEO-II IBF Device System K121892, K142347, K143518 • VALEO-II IBF Device System, LL K161405 • VALEO-II AL S…
Amedica Corp.2012—
*K161405Valeo II Interbody Fusion Device System
Summary page 5
…43518 • VALEO-II IBF Device System K121892, K142347, K143518 • VALEO-II IBF Device System, LL K161405 • VALEO-II AL System K143158 • VALEO-II OL/PL System…
Amedica Corp.2016—
*K143158Xenco Medical Lumbar Interbody System
Summary page 5
…K142347, K143518 • VALEO-II IBF Device System, LL K161405 • VALEO-II AL System K143158 • VALEO-II OL/PL System K143518 • Nuvasive TLX Interbody System…
Xenco Medical, LLC2015—
*K171633NuVasive TLX Interbody System
Summary page 5
…K143158 • VALEO-II OL/PL System K143518 • Nuvasive TLX Interbody System K171633 Intended Use / Indications for Use Indications for Use: The MONDRIAN™ Lumbar Interbody Fusion Cage is indicated for int…
Nu Vasive, Incorporated2017—

Also cleared against K121567: 1 other device →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221
K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230

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 36 years and passes through 13 companies; a new generation was cleared every 10 months on median.
  • 26 of the 245 ancestors have a recall of any class.
  • Of its descendants, K213641 (Ctl Medical Corporation, 2022) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K121567.

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. 2020, 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?

The MONDRIAN™ Lumbar Interbody Fusion Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. The system is to be used with supplemental fixation cleared for use in the lumbar spine. Hyperlordotic cage offerings (>20°) require the use of anterior fixation. DDD is defined as discogenic back pain with degeneration of the disc confirmed by…

Read the full statement (119 words)

The MONDRIAN™ Lumbar Interbody Fusion Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. The system is to be used with supplemental fixation cleared for use in the lumbar spine. Hyperlordotic cage offerings (>20°) require the use of anterior fixation. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Indications for use as stated in the FDA summary.

Also cleared against K121567

1 other device cites the same predicate.

  • K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC · 2021

More from Ctl Medical Corporation

14 FDA decisions under this applicant name. See the company

  • K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation · 2024
  • K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation · 2024
  • K231359RODIN™ Expandable Lumbar Cage SystemCtl Medical Corporation · 2023
  • K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation · 2023
  • K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation · 2022

Recent decisions in MAX

The MAX category page

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  • 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/K192863 · printed Nov 4, 2026

Cite this page

510(k) Report. “K192863: MONDRIAN Lumbar Interbody Fusion Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K192863

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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