510(k) · Cleared
ClearedVarilift -C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wenzel Spine · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Jan 29, 2013 as substantially equivalent to K111123 (Wenzel Spine, 2011) and 1 other predicate after a 336-day review. Its family tree reaches back 11 generations to 1984. 193 later devices descend from it.
- Decided
- Jan 29, 2013
- Review
- 336 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K841189 (1984). 29 ancestors in all. 193 later devices descend from it, 4 citing it directly.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 2 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 1 generation backK111123 Varilift Cervical Interbody Fusion SystemWenzel Spine · 2011
- This deviceK120603 Varilift -CWenzel Spine · 2013
- Descendant · cites it directly · 125 of its ownK172676 NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated · 2017
- Descendant · 2 generations on · 104 of its ownK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- Descendant · 3 generations on · 102 of its ownK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- Descendant · cites it directly · 100 of its ownK181435 ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018
- Descendant · 2 generations on · 99 of its ownK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
Show all 11 generations
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 8 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 5 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 4 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 3 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 2 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 1 generation backK111123 Varilift Cervical Interbody Fusion SystemWenzel Spine · 2011
- This deviceK120603 Varilift -CWenzel Spine · 2013
Showing 5 of 193 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 193 · See all- K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated · 2017 · cites it directly125descendants
- K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc. · 2019 · 2 generations on104descendants
- K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc. · 2019 · 3 generations on102descendants
- K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018 · cites it directly100descendants
- K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019 · 2 generations on99descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −10 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −9 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −8 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −5 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −4 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −3 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| −2 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| −1 | K111123 | Varilift Cervical Interbody Fusion System | Wenzel Spine | 2011 | — |
| 0 (this device) | K120603 | Varilift -C | Wenzel Spine | 2013 | — |
| +1 | K172676 | NuVasive® Modulus-C Interbody System | Nu Vasive, Incorporated | 2017 | — |
| +2 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| +3 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
| +1 | K181435 | ATEC Cervical Spacer System | Alphatec Spine, Inc. | 2018 | — |
| +2 | K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 10 | 0 |
| 2020 | 14 | 0 |
| 2021 | 16 | 0 |
| 2022 | 23 | 0 |
| 2023 | 25 | 0 |
| 2024 | 32 | 0 |
| 2025 | 36 | 0 |
| 2026 | 35 | 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 ODP? 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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K111123 | Varilift Cervical Interbody Fusion SystemSummary page 1…s The VaniLift-C* was shown to be substantially equivalent to legally marketed predicate device. The predicate devices are the VaiL-ift Cervical Interbody Fusion System (K111123) and the BAK/C Interbody Fusion Device (P980048). SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES The VaniLift Cervical Int… | 2011 |
| * | P980048 | Bak/Cervical (Bak/C) Interbody Fusion SystemSummary page 1…equivalent to legally marketed predicate device. The predicate devices are the VaiL-ift Cervical Interbody Fusion System (K111123) and the BAK/C Interbody Fusion Device (P980048). SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES The VaniLift Cervical Interbody Fusion System is substantially equivalent… | 2001 |
What descends from it? (193)
See all 1934 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 29 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 29 ancestors have a recall of any class.
- Of its descendants, K172676 (Nu Vasive, Incorporated, 2017) has gone furthest, with 125 descendants of its own.
- 1 other device also cites its predicate K111123.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
The Wenzel Spine VaniLift® Cervical Interbody Fusion System is indicated use in skeletally mature patients with degenerative disc disease (ODD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DOD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. The Wenzel Spine…
Read the full statement (144 words)
The Wenzel Spine VaniLift® Cervical Interbody Fusion System is indicated use in skeletally mature patients with degenerative disc disease (ODD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DOD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level.
The Wenzel Spine VaniLift Cervical Interbody Fusion System is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral or a bilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft bone. The Wenzel Spine Varilift Cervical Interbody Fusion System may be used with or without supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral fusion device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120603 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120603: Varilift -C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120603
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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