510(k) · Cleared
ClearedZavation ALIF System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zavation Medical Products, LLC · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Jun 14, 2023 as substantially equivalent to K170157 (Globus Medical, Inc., 2017) and 5 other predicates after a 90-day review. Its family tree reaches back 25 generations to 1984. 1 of the 518 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Jun 14, 2023
- Review
- 90 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 25 generations to K841189 (1984). 515 ancestors in all, the oldest K792352 (1979). 2 later devices descend from it, 1 citing it directly. 1 of the 518 devices in this family, counting this one, has a Class I recall.
- Root · 25 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations between
- 3 generations backK191354 Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2019
- 2 generations backK202305 Zavation IBF SystemZavation Medical Products, LLC · 2020
- 1 generation backK211306 LabyrinthZavation Medical Products, LLC · 2021
- This deviceK230731 Zavation ALIF SystemZavation Medical Products, LLC · 2023
- Descendant · cites it directly · 1 of its ownK233509 Zavation IBF System, Zavation Varisync Plate System and Varisync…Zavation Medical Products, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK250769 Dakota LP SystemPrecision Spine, Inc. · 2025
Show all 25 generations
- Root · 25 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 24 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 23 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 22 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 21 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 20 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 19 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 18 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 17 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 16 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 15 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 14 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 13 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 12 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 11 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 10 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 9 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 8 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 7 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 6 generations backK160125 Cascadia Interbody SystemK2m · 2016
- 5 generations backK162264 Cascadia Interbody SystemK2m, Inc. · 2016
- 4 generations backK172941 CASCADIA Interbody SystemK2m · 2018
- 3 generations backK191354 Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2019
- 2 generations backK202305 Zavation IBF SystemZavation Medical Products, LLC · 2020
- 1 generation backK211306 LabyrinthZavation Medical Products, LLC · 2021
- This deviceK230731 Zavation ALIF SystemZavation Medical Products, LLC · 2023
Class I recalls in this family
- K073202 Ardis Spacer6 generations back · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −25 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −24 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −23 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −22 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −21 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −20 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −19 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −18 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −17 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −16 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −15 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −14 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −13 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −12 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −11 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −10 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −9 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −8 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −7 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −6 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| −5 | K162264 | Cascadia Interbody System | K2m, Inc. | 2016 | — |
| −4 | K172941 | CASCADIA Interbody System | K2m | 2018 | — |
| −3 | K191354 | Ti3Z Cervical Interbody System | Zavation Medical Products, LLC | 2019 | — |
| −2 | K202305 | Zavation IBF System | Zavation Medical Products, LLC | 2020 | — |
| −1 | K211306 | Labyrinth | Zavation Medical Products, LLC | 2021 | — |
| 0 (this device) | K230731 | Zavation ALIF System | Zavation Medical Products, LLC | 2023 | — |
| +1 | K233509 | Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer… | Zavation Medical Products, LLC | 2024 | — |
| +2 | K250769 | Dakota LP System | Precision Spine, Inc. | 2025 | — |
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 | 2 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 7 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 8 | 0 |
| 2001 | 15 | 0 |
| 2002 | 13 | 0 |
| 2003 | 20 | 0 |
| 2004 | 31 | 0 |
| 2005 | 27 | 0 |
| 2006 | 17 | 0 |
| 2007 | 19 | 0 |
| 2008 | 53 | 1 |
| 2009 | 41 | 0 |
| 2010 | 28 | 0 |
| 2011 | 42 | 0 |
| 2012 | 23 | 0 |
| 2013 | 27 | 0 |
| 2014 | 32 | 0 |
| 2015 | 22 | 0 |
| 2016 | 19 | 0 |
| 2017 | 12 | 0 |
| 2018 | 6 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 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 |
|---|---|---|---|
| * | K170157 | INDEPENDENCE® SpacersSummary page 5…available with or without titanium plasma coating on the device. The plasma coating is made from commercially pure titanium per (ASTM F1580). Primary Predicate Device: K170157 Independence Spacers [Globus] Additional Predicate Device: K142271 Zavation Z-Link Lumbar [Zavation] K212811 T1 3Z Lumbar Inter… | 2017 |
| * | K142271 | Zavation Z-Link LumbarSummary page 5…plasma coating is made from commercially pure titanium per (ASTM F1580). Primary Predicate Device: K170157 Independence Spacers [Globus] Additional Predicate Device: K142271 Zavation Z-Link Lumbar [Zavation] K212811 T1 3Z Lumbar Interbody System [Zavation] K200084 Zavation IBF System [Zavation] K211306… | 2014 |
| * | K212811 | Ti3Z Lumbar Interbody SystemSummary page 5…ure titanium per (ASTM F1580). Primary Predicate Device: K170157 Independence Spacers [Globus] Additional Predicate Device: K142271 Zavation Z-Link Lumbar [Zavation] K212811 T1 3Z Lumbar Interbody System [Zavation] K200084 Zavation IBF System [Zavation] K211306 LABYRINTH [Zavation] K214047 El Capitan A… | 2022 |
| * | K200084 | Zavation IBF SystemSummary page 5…e Device: K170157 Independence Spacers [Globus] Additional Predicate Device: K142271 Zavation Z-Link Lumbar [Zavation] K212811 T1 3Z Lumbar Interbody System [Zavation] K200084 Zavation IBF System [Zavation] K211306 LABYRINTH [Zavation] K214047 El Capitan Anterior Interbody Fusion System [Astura Medical]… | 2020 |
| * | K211306 | LabyrinthSummary page 5…[Globus] Additional Predicate Device: K142271 Zavation Z-Link Lumbar [Zavation] K212811 T1 3Z Lumbar Interbody System [Zavation] K200084 Zavation IBF System [Zavation] K211306 LABYRINTH [Zavation] K214047 El Capitan Anterior Interbody Fusion System [Astura Medical] Performance Data: A comparison of the… | 2021 |
| * | K214047 | EL CAPITAN Anterior Lumbar Interbody Fusion SystemSummary page 5…te Device: K142271 Zavation Z-Link Lumbar [Zavation] K212811 T1 3Z Lumbar Interbody System [Zavation] K200084 Zavation IBF System [Zavation] K211306 LABYRINTH [Zavation] K214047 El Capitan Anterior Interbody Fusion System [Astura Medical] Performance Data: A comparison of the test results indicates that… | 2022 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233509 | Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System… | 2024 | 1 |
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 39 years and passes through 15 companies; a new generation was cleared every 10 months on median.
- 58 of the 515 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K233509 (Zavation Medical Products, LLC, 2024) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K170157.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
The Zavation ALIF System is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These DDD patients may also have up to Grade I…
Read the full statement (184 words)
The Zavation ALIF System is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the Zavation ALIF System is to be filled with autogenous bone graft material.
The Zavation ALIF System spacer and plate assembly are an integrated fusion device intended for stand-alone use when used with screws. When used with anchors only the recessed plate may be used, and the assembly is intended for use with additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine.
Hyperlordotic interbody devices (>20 degrees) must be used with supplemental fixation (e.g. posterior fixation) that has been cleared by the FDA for the use in the lumbar spine.
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/K230731 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230731: Zavation ALIF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230731
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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