510(k) Report

510(k) · Cleared

Cleared

Varian cage

K172756510(k) TraditionalCleared Dec 8, 201786-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

Medyssey USA, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Dec 8, 2017 as substantially equivalent to K151900 (Wenzel Spine, Inc., 2015) and 5 other predicates after an 86-day review. Its family tree reaches back 15 generations to 1984. 1 later device descends from it.

Decided
Dec 8, 2017
Review
86 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
6

Its longest line of descent runs back 15 generations to K841189 (1984). 80 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2015: 1 other ancestor2014: 2 other ancestors2012: 1 other ancestor2010: 4 other ancestors2013: 1 other ancestor2011: 4 other ancestors2009: 4 other ancestors1999: 2 other ancestors2008: 4 other ancestors2007: 3 other ancestors2005: 5 other ancestors1996: 2 other ancestors2004: 8 other ancestors2003: 7 other ancestors2001: 9 other ancestors2000: 2 other ancestors2002: 6 other ancestors2021: 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 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 5 other ancestors3 generations back: 8 other ancestors4 generations back: 9 other ancestors5 generations back: 8 other ancestors6 generations back: 11 other ancestors7 generations back: 12 other ancestors8 generations back: 6 other ancestors9 generations back: 1 other ancestor 1 generation forward: 1 descendant K132505 · 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. · 1984−15−10−50
  1. Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 11 generations between
  3. 3 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
  4. 2 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
  5. 1 generation backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
  6. This deviceK172756 Varian cageMedyssey USA, Inc. · 2017
  7. Descendant · cites it directly · 0 of its ownK203327 VERTACONNECT TLIF CageSignus Medizintechnik · 2021
Show all 15 generations
  1. Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 14 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 13 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 12 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 11 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 10 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 9 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 8 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 7 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 6 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
  11. 5 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
  12. 4 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
  13. 3 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
  14. 2 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
  15. 1 generation backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
  16. This deviceK172756 Varian cageMedyssey USA, Inc. · 2017

Most influential descendants

Showing 1 of 1 · See all
  • K203327VERTACONNECT TLIF CageSignus Medizintechnik · 2021 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−15K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−14K990148Stackable Cage SystemDepuy Motech Acromed1999—
−13K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−12K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−11K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−10K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−9K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−8K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−7K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−6K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008—
−5K094025Crescent Spinal SystemMedtronic Sofamor Danek2010—
−4K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011—
−3K121683Acculif TL CageCoalign Innovations, Inc.2012—
−2K123752Acculif TL and PL CageCoalign Innovations, Inc.2013—
−1K132505Acculif TL and PL CageCoalign Innovations, Inc.20133
0 (this device)K172756Varian cageMedyssey USA, Inc.2017—
+1K203327VERTACONNECT TLIF CageSignus Medizintechnik2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
199920
200020
200190
200260
200370
200480
200550
200730
200840
200940
201040
201140
201210
201310
201420
201510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
FIG. 1 — Lineage of K172756, 1984–2021Source: 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 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? (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
*K151900VariLift-L Interbody Fusion Device
Summary page 4
…Class: II Product Codes: MAX Primary Predicate Device: Wenzel Spine, Inc., VariLift®-L Interbody Fusion Device (K151900) Additional Predicates: CoAlign Innovations AccuLIF TL and PL Cage (K132505, K093669)…
Wenzel Spine, Inc.2015—
*K132505Acculif TL and PL Cage
Summary page 4
…Device: Wenzel Spine, Inc., VariLift®-L Interbody Fusion Device (K151900) Additional Predicates: CoAlign Innovations AccuLIF TL and PL Cage (K132505, K093669) Medyssey BN Cage (K140564) INNESIS PEEK TL C…
Coalign Innovations, Inc.20133
*K093669Sec Ibf Cage
Summary page 4
…ft®-L Interbody Fusion Device (K151900) Additional Predicates: CoAlign Innovations AccuLIF TL and PL Cage (K132505, K093669) Medyssey BN Cage (K140564) INNESIS PEEK TL Cage (K140577)…
Innvotec Surgical, Inc.2010—
*K140564BN Lumbar Cage System
Summary page 4
…(K151900) Additional Predicates: CoAlign Innovations AccuLIF TL and PL Cage (K132505, K093669) Medyssey BN Cage (K140564) INNESIS PEEK TL Cage (K140577) Medyssey LT Cage (K121246) Indications For Use…
Medyssey USA, Inc.2014—
*K140577Innesis Peek TL Cage
Summary page 4
…ons AccuLIF TL and PL Cage (K132505, K093669) Medyssey BN Cage (K140564) INNESIS PEEK TL Cage (K140577) Medyssey LT Cage (K121246) Indications For Use: The Varian cage is indicated for intervertebral bo…
Bk Meditech, Co., Ltd.2014—
*K121246Medyssy LT Cage System
Summary page 4
…K093669) Medyssey BN Cage (K140564) INNESIS PEEK TL Cage (K140577) Medyssey LT Cage (K121246) Indications For Use: The Varian cage is indicated for intervertebral body fusion of the lumbar spi…
Medyssey Co, Ltd.2012—

Also cleared against K151900: 1 other device →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K203327VERTACONNECT TLIF CageSignus Medizintechnik20210

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 11 companies; a new generation was cleared every 1.0 years on median.
  • 6 of the 80 ancestors have a recall of any class.
  • Of its descendants, K203327 (Signus Medizintechnik, 2021) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K151900.

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?

The Varian cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

Varian cage is designed to be implanted bi-laterally via a posterior (PLIF) approach. The device is intended for use with supplemental fixation and is intended for use with autograft to facilitate fusion.

Indications for use as stated in the FDA summary.

Also cleared against K151900

1 other device cites the same predicate.

  • K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc. · 2019

More from Medyssey USA, Inc.

19 FDA decisions under this applicant name. See the company

  • K232218Zenius™ Spinal SystemMedyssey USA, Inc. · 2023
  • K230301Athena III Cervical Plate SystemMedyssey USA, Inc. · 2023
  • K223654Medussa-PL CageMedyssey USA, Inc. · 2022
  • K200283Medussa-PL CageMedyssey USA, Inc. · 2020
  • K183407Triton CageMedyssey USA, 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/K172756 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172756: Varian cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172756

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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