510(k) · Cleared
ClearedZavation VariSync Plate System and VariSync Spacer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zavation Medical Products, LLC · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Aug 12, 2022 as substantially equivalent to K202305 (Zavation Medical Products, LLC, 2020) and 4 other predicates after a 123-day review. Its family tree reaches back 24 generations to 1984. 1 of the 507 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it.
- Decided
- Aug 12, 2022
- Review
- 123 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 24 generations to K841189 (1984). 500 ancestors in all, the oldest K792352 (1979). 6 later devices descend from it, 2 citing it directly. 1 of the 507 devices in this family, counting this one, has a Class I recall.
- Root · 24 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 20 generations between
- 3 generations backK172941 CASCADIA Interbody SystemK2m · 2018
- 2 generations backK191354 Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2019
- 1 generation backK202305 Zavation IBF SystemZavation Medical Products, LLC · 2020
- This deviceK221049 Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC · 2022
- Descendant · cites it directly · 3 of its ownK231766 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2023
- Descendant · 2 generations on · 2 of its ownK243015 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc. · 2024
- Descendant · 3 generations on · 1 of its ownK250486 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2025
- Descendant · cites it directly · 1 of its ownK233509 Zavation IBF System, Zavation Varisync Plate System and Varisync…Zavation Medical Products, LLC · 2024
- Descendant · 4 generations on · 0 of its ownK261451 ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026
Show all 24 generations
- Root · 24 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 23 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 22 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 21 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 20 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 19 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 18 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 17 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 16 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 15 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 14 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 13 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 12 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 11 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 10 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 9 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 8 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 7 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 6 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 5 generations backK160125 Cascadia Interbody SystemK2m · 2016
- 4 generations backK162264 Cascadia Interbody SystemK2m, Inc. · 2016
- 3 generations backK172941 CASCADIA Interbody SystemK2m · 2018
- 2 generations backK191354 Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2019
- 1 generation backK202305 Zavation IBF SystemZavation Medical Products, LLC · 2020
- This deviceK221049 Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer6 generations back · 2008
Most influential descendants
Showing 5 of 6 · See all- K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2023 · cites it directly3descendants
- K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc. · 2024 · 2 generations on2descendants
- K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2025 · 3 generations on1descendant
- K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC · 2024 · cites it directly1descendant
- K261451ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −24 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −23 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −22 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −21 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −20 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −19 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −18 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −17 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −16 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −15 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −14 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −13 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −12 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −11 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −10 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −9 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −8 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −7 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −6 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −5 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| −4 | K162264 | Cascadia Interbody System | K2m, Inc. | 2016 | — |
| −3 | K172941 | CASCADIA Interbody System | K2m | 2018 | — |
| −2 | K191354 | Ti3Z Cervical Interbody System | Zavation Medical Products, LLC | 2019 | — |
| −1 | K202305 | Zavation IBF System | Zavation Medical Products, LLC | 2020 | — |
| 0 (this device) | K221049 | Zavation VariSync Plate System and VariSync Spacer System | Zavation Medical Products, LLC | 2022 | — |
| +1 | K231766 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | 2023 | — |
| +2 | K243015 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies, Inc. | 2024 | — |
| +3 | K250486 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | 2025 | — |
| +1 | K233509 | Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer… | Zavation Medical Products, LLC | 2024 | — |
| +4 | K261451 | ZSAlign Cervical Interbody System | ZSFab, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 7 | 0 |
| 1997 | 5 | 0 |
| 1998 | 5 | 0 |
| 1999 | 7 | 0 |
| 2000 | 11 | 0 |
| 2001 | 17 | 0 |
| 2002 | 15 | 0 |
| 2003 | 22 | 0 |
| 2004 | 32 | 0 |
| 2005 | 26 | 0 |
| 2006 | 18 | 0 |
| 2007 | 22 | 0 |
| 2008 | 52 | 1 |
| 2009 | 40 | 0 |
| 2010 | 29 | 0 |
| 2011 | 38 | 0 |
| 2012 | 23 | 0 |
| 2013 | 24 | 0 |
| 2014 | 28 | 0 |
| 2015 | 14 | 0 |
| 2016 | 15 | 0 |
| 2017 | 7 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 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.
1 device in this family has a Class I recall. 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 OVE device
- #1 K241846 E3D™-C Interbody Systemscore 32.1 · 32 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K202305 | Zavation IBF SystemSummary page 5…6) with a Tantalum alloy position marker (ASTM F560). The plate and screws are titanium alloy (ASTM F136). Predicate Device: Primary -Zavation IBF System, Zavation LLC (K202305) Primary – Zavation Cervical Plate System (181244) Additional – Globus COALITION AGX (K142218) Additional – Elevation Spine Saber… | 2020 |
| * | K181244 | Zavation Cervical Plate SystemSummary page 5…). The plate and screws are titanium alloy (ASTM F136). Predicate Device: Primary -Zavation IBF System, Zavation LLC (K202305) Primary – Zavation Cervical Plate System (181244) Additional – Globus COALITION AGX (K142218) Additional – Elevation Spine Saber-C (K190885) Additional – Zavation Ti3Z Cervical I… | 2018 |
| * | K142218 | Coalition AGX Plate and Coalition AGX SpacerSummary page 5…(ASTM F136). Predicate Device: Primary -Zavation IBF System, Zavation LLC (K202305) Primary – Zavation Cervical Plate System (181244) Additional – Globus COALITION AGX (K142218) Additional – Elevation Spine Saber-C (K190885) Additional – Zavation Ti3Z Cervical Interbody System (K202398) Technological Ch… | 2015 |
| * | K190885 | Elevation Spine Saber-C SystemSummary page 5…on IBF System, Zavation LLC (K202305) Primary – Zavation Cervical Plate System (181244) Additional – Globus COALITION AGX (K142218) Additional – Elevation Spine Saber-C (K190885) Additional – Zavation Ti3Z Cervical Interbody System (K202398) Technological Characteristics: The Zavation VariSync Plate and… | 2019 |
| * | K202398 | Ti3Z Cervical Interbody SystemSummary page 5…al Plate System (181244) Additional – Globus COALITION AGX (K142218) Additional – Elevation Spine Saber-C (K190885) Additional – Zavation Ti3Z Cervical Interbody System (K202398) Technological Characteristics: The Zavation VariSync Plate and the Zavation VariSync Spacer possesses the same technological c… | 2021 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 6 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 38 years and passes through 15 companies; a new generation was cleared every 11 months on median.
- 61 of the 500 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K231766 (Kyocera Medical Technologies Inc. (KMTI), 2023) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K202305.
How does its category compare?
All OVE devicesOVE Intervertebral Fusion Device With Integrated Fixation, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · OVE
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVE
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVE
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVE
132in 2025
MAUDE reports naming product code OVE, 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 | 1 | — | 0 | 0 |
| 2008 | 4 | 131 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 210 | 0 | 2 |
| 2011 | 8 | 139 | 0 | 19 |
| 2012 | 7 | 125 | 0 | 59 |
| 2013 | 5 | 71 | 1 | 250 |
| 2014 | 11 | 168 | 1 | 150 |
| 2015 | 12 | 113 | 1 | 173 |
| 2016 | 15 | 149 | 1 | 145 |
| 2017 | 9 | 100 | 1 | 134 |
| 2018 | 7 | 105 | 0 | 210 |
| 2019 | 7 | 87 | 0 | 169 |
| 2020 | 13 | 149 | 0 | 162 |
| 2021 | 10 | 93 | 2 | 186 |
| 2022 | 10 | 144 | 0 | 200 |
| 2023 | 16 | 97 | 0 | 148 |
| 2024 | 6 | 56 | 0 | 142 |
| 2025 | 10 | 105 | 0 | 132 |
| 2026 | 13 | 66 | 0 | — |
What is it indicated for?
The VariSync Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis. The…
Read the full statement (198 words)
The VariSync Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
The VariSync Spacer is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The VariSync Spacer is to be filled with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft in skeletally mature patients. These devices are intended to be used with supplemental fixation such as the Zavation VariSync Plate, Zavation Midline Plate, Zavation EZ Plate, or Zavation Cervical Plate Systems. When used with the VariSync Plate, the assembly takes on the indications of the VariSync Spacer, with the VariSync Plate acting as the supplemental fixation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K221049 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221049: Zavation VariSync Plate System and VariSync Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221049
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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