510(k) · Cleared
ClearedWenzel Spine Varilift Interbody Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wenzel Spine · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Aug 5, 2010 as substantially equivalent to P950002 (Zimmer Spine, Inc., 1996) and 5 other predicates after a 135-day review. Its family tree reaches back 9 generations to 1984. 16 later devices descend from it.
- Decided
- Aug 5, 2010
- Review
- 135 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 9 generations to K841189 (1984). 29 ancestors in all. 16 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 5 generations between
- 3 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 2 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 1 generation backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- This deviceK100820 Wenzel Spine Varilift Interbody Fusion SystemWenzel Spine · 2010
- Descendant · cites it directly · 8 of its ownK151900 VariLift-L Interbody Fusion DeviceWenzel Spine, Inc. · 2015
- Descendant · 2 generations on · 5 of its ownK180822 VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion…Wenzel Spine, Inc. · 2019
- Descendant · cites it directly · 5 of its ownK151481 Sahara Stabilization SystemK2m, Inc. · 2015
- Descendant · 3 generations on · 4 of its ownK231076 VariLift®-C Interbody Fusion SystemWenzel Spine, Inc. · 2023
- Descendant · 2 generations on · 4 of its ownK201585 Monterey AL Interbody SystemStryker Corporation · 2020 · Recalled
Show all 9 generations
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 7 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 6 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 5 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 4 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 3 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 2 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 1 generation backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- This deviceK100820 Wenzel Spine Varilift Interbody Fusion SystemWenzel Spine · 2010
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K151900VariLift-L Interbody Fusion DeviceWenzel Spine, Inc. · 2015 · cites it directly8descendants
- K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc. · 2019 · 2 generations on5descendants
- K151481Sahara Stabilization SystemK2m, Inc. · 2015 · cites it directly5descendants
- K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc. · 2023 · 3 generations on4descendants
- K201585Monterey AL Interbody SystemStryker Corporation · 2020 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −8 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −7 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −6 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −5 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −4 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −3 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −2 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −1 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| 0 (this device) | K100820 | Wenzel Spine Varilift Interbody Fusion System | Wenzel Spine | 2010 | — |
| +1 | K151900 | VariLift-L Interbody Fusion Device | Wenzel Spine, Inc. | 2015 | — |
| +2 | K180822 | VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System | Wenzel Spine, Inc. | 2019 | — |
| +1 | K151481 | Sahara Stabilization System | K2m, Inc. | 2015 | — |
| +3 | K231076 | VariLift®-C Interbody Fusion System | Wenzel Spine, Inc. | 2023 | — |
| +2 | K201585 | Monterey AL Interbody System | Stryker Corporation | 2020 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 0 |
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 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | P950002 | Bak Interbody Fusion SystemSummary page 1…body Fusion System (VariLift-L and VaniLift-A) IDENTIFICATION OF PREDICATES - BAK® Cage (P950002) - RAY® Threaded Fusion Cage (P950019) -… | 1996 |
| * | P950019 | Ray Threaded Fusion Cage (TFC)(TM) with InstrumentationSummary page 1…) IDENTIFICATION OF PREDICATES - BAK® Cage (P950002) - RAY® Threaded Fusion Cage (P950019) - Lumbar I/F Cage (P960025) - Asfora Bul… | 1996 |
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 1…BAK® Cage (P950002) - RAY® Threaded Fusion Cage (P950019) - Lumbar I/F Cage (P960025) - Asfora Bullet Cage System (K090048) -… | 1999 |
| * | K090048 | Asfora Bullet Cage SystemSummary page 1…ed Fusion Cage (P950019) - Lumbar I/F Cage (P960025) - Asfora Bullet Cage System (K090048) - Paramount (K072120) -- L-Varlock (K0805… | 2009 |
| * | K072120 | Paramount Intervertebral Body Fusion DeviceSummary page 1…Lumbar I/F Cage (P960025) - Asfora Bullet Cage System (K090048) - Paramount (K072120) -- L-Varlock (K080537). DEVICE DESCRIPTION The proposed Wenzel Spine VaniLift Interbo… | 2007 |
| * | K080537 | L-VarlockSummary page 1…- Asfora Bullet Cage System (K090048) - Paramount (K072120) -- L-Varlock (K080537). DEVICE DESCRIPTION The proposed Wenzel Spine VaniLift Interbody Fusion System will be offered in two (2) configurations of vari… | 2008 |
What descends from it? (16)
See all 163 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 26 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 4 of the 29 ancestors have a recall of any class.
- Of its descendants, K151900 (Wenzel Spine, Inc., 2015) has gone furthest, with 8 descendants of its own.
- 34 other devices also cite its predicate P950002.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
The Wenzel Spine VariLift 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. DODD is defined as back pain of discogenic origin…
Read the full statement (139 words)
The Wenzel Spine VariLift 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. DODD 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-A may 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.
https://510kreport.com/device/K100820 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100820: Wenzel Spine Varilift Interbody Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100820
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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