510(k) · Cleared
ClearedZavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zavation Medical Products, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Apr 10, 2024 as substantially equivalent to K201367 (Integrity Implants, Inc., 2020) and 4 other predicates after a 162-day review. Its family tree reaches back 26 generations to 1984. 1 of the 590 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Apr 10, 2024
- Review
- 162 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 26 generations to K841189 (1984). 588 ancestors in all, the oldest K792352 (1979). 1 later device descends from it, 1 citing it directly. 1 of the 590 devices in this family, counting this one, has a Class I recall.
- Root · 26 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 22 generations between
- 3 generations backK202305 Zavation IBF SystemZavation Medical Products, LLC · 2020
- 2 generations backK211306 LabyrinthZavation Medical Products, LLC · 2021
- 1 generation backK230731 Zavation ALIF SystemZavation Medical Products, LLC · 2023
- This deviceK233509 Zavation IBF System, Zavation Varisync Plate System and Varisync…Zavation Medical Products, LLC · 2024
- Descendant · cites it directly · 0 of its ownK250769 Dakota LP SystemPrecision Spine, Inc. · 2025
Show all 26 generations
- Root · 26 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 25 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 24 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 23 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 22 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 21 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 20 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 19 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 18 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 17 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 16 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 15 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 14 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 13 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 12 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 11 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 10 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 9 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 8 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 7 generations backK160125 Cascadia Interbody SystemK2m · 2016
- 6 generations backK162264 Cascadia Interbody SystemK2m, Inc. · 2016
- 5 generations backK172941 CASCADIA Interbody SystemK2m · 2018
- 4 generations backK191354 Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2019
- 3 generations backK202305 Zavation IBF SystemZavation Medical Products, LLC · 2020
- 2 generations backK211306 LabyrinthZavation Medical Products, LLC · 2021
- 1 generation backK230731 Zavation ALIF SystemZavation Medical Products, LLC · 2023
- This deviceK233509 Zavation IBF System, Zavation Varisync Plate System and Varisync…Zavation Medical Products, LLC · 2024
Class I recalls in this family
- K073202 Ardis Spacer7 generations back · 2008
Most influential descendants
Showing 1 of 1 · See all- K250769Dakota LP SystemPrecision Spine, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −26 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −25 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −24 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −23 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −22 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −21 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −20 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −19 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −18 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −17 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −16 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −15 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −14 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −13 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −12 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −11 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −10 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −9 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −8 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −7 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| −6 | K162264 | Cascadia Interbody System | K2m, Inc. | 2016 | — |
| −5 | K172941 | CASCADIA Interbody System | K2m | 2018 | — |
| −4 | K191354 | Ti3Z Cervical Interbody System | Zavation Medical Products, LLC | 2019 | — |
| −3 | K202305 | Zavation IBF System | Zavation Medical Products, LLC | 2020 | — |
| −2 | K211306 | Labyrinth | Zavation Medical Products, LLC | 2021 | — |
| −1 | K230731 | Zavation ALIF System | Zavation Medical Products, LLC | 2023 | — |
| 0 (this device) | K233509 | Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer… | Zavation Medical Products, LLC | 2024 | — |
| +1 | 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 | 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 | 33 | 0 |
| 2005 | 28 | 0 |
| 2006 | 20 | 0 |
| 2007 | 24 | 0 |
| 2008 | 56 | 1 |
| 2009 | 43 | 0 |
| 2010 | 31 | 0 |
| 2011 | 46 | 0 |
| 2012 | 25 | 0 |
| 2013 | 32 | 0 |
| 2014 | 36 | 0 |
| 2015 | 26 | 0 |
| 2016 | 23 | 0 |
| 2017 | 15 | 0 |
| 2018 | 8 | 0 |
| 2019 | 6 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (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 |
|---|---|---|---|
| * | K201367 | FlareHawk TiHawk9 Interbody Fusion SystemSummary page 11…1580). The (IBAD) coating is made from Grade 2 Commercially Pure Titanium coating that meets chemical composition requirements of (ASTM F67). Primary Predicate Device: K201367 FlareHawk Interbody Fusion System [Integrity Implants Inc.] Additional Predicate Device: K200084 Zavation IBF System [Zavation]… | 2020 |
| * | K200084 | Zavation IBF SystemSummary page 11…cal composition requirements of (ASTM F67). Primary Predicate Device: K201367 FlareHawk Interbody Fusion System [Integrity Implants Inc.] Additional Predicate Device: K200084 Zavation IBF System [Zavation] K221049 Zavation Varisync Plate System and Varisync Spacer System [Zavation] K211306 LABYRINTH Sys… | 2020 |
| * | K221049 | Zavation VariSync Plate System and VariSync Spacer SystemSummary page 11…67). Primary Predicate Device: K201367 FlareHawk Interbody Fusion System [Integrity Implants Inc.] Additional Predicate Device: K200084 Zavation IBF System [Zavation] K221049 Zavation Varisync Plate System and Varisync Spacer System [Zavation] K211306 LABYRINTH System [Zavation] K230731 Zavation ALIF Sy… | 2022 |
| * | K211306 | LabyrinthSummary page 11…ntegrity Implants Inc.] Additional Predicate Device: K200084 Zavation IBF System [Zavation] K221049 Zavation Varisync Plate System and Varisync Spacer System [Zavation] K211306 LABYRINTH System [Zavation] K230731 Zavation ALIF System [Zavation] Technological Characteristics: The subject device is identic… | 2021 |
| * | K230731 | Zavation ALIF SystemSummary page 11…Predicate Device: K200084 Zavation IBF System [Zavation] K221049 Zavation Varisync Plate System and Varisync Spacer System [Zavation] K211306 LABYRINTH System [Zavation] K230731 Zavation ALIF System [Zavation] Technological Characteristics: The subject device is identical in indications for use, surgical… | 2023 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250769 | Dakota LP System | 2025 | 0 |
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 · 7 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 40 years and passes through 15 companies; a new generation was cleared every 10 months on median.
- 68 of the 588 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K250769 (Precision Spine, Inc., 2025) has gone furthest, with 0 descendants of its own.
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. 2024, 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?
When used as a cervical intervertebral body fusion device, the Zavation IBF implants are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed…
Read the full statement (859 words)
When used as a cervical intervertebral body fusion device, the Zavation IBF implants are
intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.
When used as a lumbar intervertebral body fusion device, the Zavation IBF implants are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.
For all the above indications the Zavation IBF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Pedicle Screw System and Zavation Cervical Plate System.
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 corticancellous 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.
When used as a cervical intervertebral body fusion device, the LABYRINTH implants are
intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.
When used as a lumbar intervertebral body fusion device, the LABYRINTH implants are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.
For all the above indications the LABYRINTH implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Pedicle Screw System and Zavation Cervical Plate System.
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/K233509 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233509: Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, 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/K233509
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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