510(k) Report

510(k) · Cleared

Cleared

Varilift-L Interbody Fusion Device

K131296510(k) TraditionalCleared Sep 3, 2013120-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

Wenzel Spine, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Sep 3, 2013 as substantially equivalent to K100820 (Wenzel Spine, 2010) and 5 other predicates after a 120-day review. Its family tree reaches back 12 generations to 1984.

Decided
Sep 3, 2013
Review
120 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
6

Its longest line of descent runs back 12 generations to K841189 (1984). 44 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2010: 1 other ancestor1999: 2 other ancestors1996: 2 other ancestors2009: 1 other ancestor2008: 2 other ancestors2004: 5 other ancestors2003: 4 other ancestors2002: 5 other ancestors2000: 2 other ancestors2005: 1 other ancestor2001: 7 other ancestorsK841189 · 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) K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 2004K042930 · Spacevision Cage System · Spine Vision, Inc. · 2004K062759 · 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. · 2008K090353 · Perimeter Interbody Fusion Device · Medtronic Sofamor Danek · 2009K111525 · Perimeter Interbody Fusion Device · Medtronic Sofamor Danek · 201119801985199019952000200520102015
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 5 other ancestors3 generations back: 5 other ancestors4 generations back: 6 other ancestors5 generations back: 5 other ancestors6 generations back: 4 other ancestors7 generations back: 2 other ancestors8 generations back: 1 other ancestor K111525 · Perimeter Interbody Fusion Device · Medtronic Sofamor Danek · 2011K090353 · Perimeter Interbody Fusion Device · Medtronic Sofamor Danek · 2009K073291 · 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. · 1984−10−50
  1. Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 8 generations between
  3. 3 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
  4. 2 generations backK090353 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2009
  5. 1 generation backK111525 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2011
  6. This deviceK131296 Varilift-L Interbody Fusion DeviceWenzel Spine, Inc. · 2013
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 backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 6 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 5 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 4 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 3 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
  11. 2 generations backK090353 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2009
  12. 1 generation backK111525 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2011
  13. This deviceK131296 Varilift-L Interbody Fusion DeviceWenzel Spine, Inc. · 2013
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—
−7K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−6K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−5K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−4K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−3K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008—
−2K090353Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2009—
−1K111525Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2011—
0 (this device)K131296Varilift-L Interbody Fusion DeviceWenzel Spine, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
199920
200020
200170
200250
200340
200450
200510
200820
200910
201010
FIG. 1 — Lineage of K131296, 1984–2013Source: 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? (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
*K100820Wenzel Spine Varilift Interbody Fusion System
Summary page 2
…cate Devices and Substantial Equivalence: The subject VariLift-LO Interbody Fusion Device is substantially equivalent to the predicate Vari~ift Interbody Fusion System (K100820, August 5, 2010) in terms of technology, design, and intended use. Additional predicate devices include down-classified cages and…
Wenzel Spine2010—
*P950002Bak Interbody Fusion System
Summary page 2
…in terms of technology, design, and intended use. Additional predicate devices include down-classified cages and other cleared interbody fusion devices such as BAK Cage (P950002), Ray Threaded Fusion Cage (P950019), Lumbar I/F Cage (P960025), and Perimeter Interbody Fusion Device (K111525, K090353). Summa…
Zimmer Spine, Inc.1996—
*P950019Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation
Summary page 2
…intended use. Additional predicate devices include down-classified cages and other cleared interbody fusion devices such as BAK Cage (P950002), Ray Threaded Fusion Cage (P950019), Lumbar I/F Cage (P960025), and Perimeter Interbody Fusion Device (K111525, K090353). Summary of Non-Clinical Performance Testi…
Stryker Spine19961
*P960025Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws
Summary page 2
…edicate devices include down-classified cages and other cleared interbody fusion devices such as BAK Cage (P950002), Ray Threaded Fusion Cage (P950019), Lumbar I/F Cage (P960025), and Perimeter Interbody Fusion Device (K111525, K090353). Summary of Non-Clinical Performance Testing: Design Modifications t…
Depuy Spine, Inc.1999—
*K111525Perimeter Interbody Fusion Device
Summary page 2
…other cleared interbody fusion devices such as BAK Cage (P950002), Ray Threaded Fusion Cage (P950019), Lumbar I/F Cage (P960025), and Perimeter Interbody Fusion Device (K111525, K090353). Summary of Non-Clinical Performance Testing: Design Modifications to Existing Sizes: Non-clinical testing was conduc…
Medtronic Sofamor Danek2011—
*K090353Perimeter Interbody Fusion Device
Summary page 2
…eared interbody fusion devices such as BAK Cage (P950002), Ray Threaded Fusion Cage (P950019), Lumbar I/F Cage (P960025), and Perimeter Interbody Fusion Device (K111525, K090353). Summary of Non-Clinical Performance Testing: Design Modifications to Existing Sizes: Non-clinical testing was conducted to de…
Medtronic Sofamor Danek2009—

Also cleared against K100820: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 29 years and passes through 10 companies; a new generation was cleared every 1.7 years on median.
  • 5 of the 44 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K100820.

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. 2013, 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 Wenzei Spine VaniLift Interbody Fusion System (VariLift-L and VaniLift-A) is indicated for intervertebral body fusion of the lumbar spine, from L2 to Si, 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 (DOD) with up to Grade I spondylolisthesis. DD is defined as back pain of discogenic origin…

Read the full statement (138 words)

The Wenzei Spine VaniLift Interbody Fusion System (VariLift-L and VaniLift-A) is indicated for intervertebral body fusion of the lumbar spine, from L2 to Si, 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 (DOD) with up to Grade I spondylolisthesis. DD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

VariLift-L is designed to be implanted bi-laterally via a posterior (PLIF) approach or as a single device via a transverse (TLIF) approach. VaniLift-A is designed to be implanted bi-laterally via an anterior (ALIF) approach. VariLift-L and VaniLift-Amay be implanted with or without supplemental fixation and are intended for use with autograft to facilitate fusion.

Indications for use as stated in the FDA summary.

Also cleared against K100820

2 other devices cite the same predicate.

  • K151481Sahara Stabilization SystemK2m, Inc. · 2015
  • K151900VariLift-L Interbody Fusion DeviceWenzel Spine, Inc. · 2015

More from Wenzel Spine, Inc.

7 FDA decisions under this applicant name. See the company

  • K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc. · 2026
  • K250247panaSIa SI Fusion SystemWenzel Spine, Inc. · 2025
  • K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc. · 2023
  • K231807primaLOK™ SP Interspinous Fusion SystemWenzel Spine, Inc. · 2023
  • K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, 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/K131296 · printed Nov 6, 2026

Cite this page

510(k) Report. “K131296: Varilift-L Interbody Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131296

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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