510(k) · Cleared
ClearedZavation IBF 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 Jul 10, 2018 as substantially equivalent to K162206 (Zavation, LLC, 2017) and 2 other predicates after a 61-day review. Its family tree reaches back 15 generations to 1984. 22 later devices descend from it.
- Decided
- Jul 10, 2018
- Review
- 61 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K841189 (1984). 83 ancestors in all. 22 later devices descend from it, 7 citing it directly.
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations between
- 3 generations backK112664 Zavation Ibf SystemsZavation, LLC · 2011
- 2 generations backK120576 Zavation Ibf SystemZavation, LLC · 2012
- 1 generation backK162206 Zavation IBFZavation, LLC · 2017
- This deviceK181246 Zavation IBF SystemZavation Medical Products, LLC · 2018
- Descendant · cites it directly · 13 of its ownK191354 Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2019
- Descendant · cites it directly · 9 of its ownK202398 Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2021
- Descendant · cites it directly · 9 of its ownK202305 Zavation IBF SystemZavation Medical Products, LLC · 2020
- Descendant · cites it directly · 8 of its ownK200084 Zavation IBF SystemZavation Medical Products, LLC · 2020
- Descendant · 2 generations on · 6 of its ownK221049 Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC · 2022
Show all 15 generations
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 13 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 12 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 9 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 8 generations backK051454 Aleutian Spacer SystemK2m, LLC · 2005
- 7 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- 6 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- 5 generations backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
- 4 generations backK110843 Aleutian Spacer SystemK2m, Inc. · 2011
- 3 generations backK112664 Zavation Ibf SystemsZavation, LLC · 2011
- 2 generations backK120576 Zavation Ibf SystemZavation, LLC · 2012
- 1 generation backK162206 Zavation IBFZavation, LLC · 2017
- This deviceK181246 Zavation IBF SystemZavation Medical Products, LLC · 2018
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2019 · cites it directly13descendants
- K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2021 · cites it directly9descendants
- K202305Zavation IBF SystemZavation Medical Products, LLC · 2020 · cites it directly9descendants
- K200084Zavation IBF SystemZavation Medical Products, LLC · 2020 · cites it directly8descendants
- K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC · 2022 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −14 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −13 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −12 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −9 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −8 | K051454 | Aleutian Spacer System | K2m, LLC | 2005 | — |
| −7 | K063399 | Aleutian Spacer System | K2m, Inc. | 2007 | — |
| −6 | K082698 | Aleutian Ibf System | K2m, Inc. | 2009 | — |
| −5 | K101302 | Aleutian Ibf System | K2m, Inc. | 2010 | — |
| −4 | K110843 | Aleutian Spacer System | K2m, Inc. | 2011 | — |
| −3 | K112664 | Zavation Ibf Systems | Zavation, LLC | 2011 | — |
| −2 | K120576 | Zavation Ibf System | Zavation, LLC | 2012 | — |
| −1 | K162206 | Zavation IBF | Zavation, LLC | 2017 | — |
| 0 (this device) | K181246 | Zavation IBF System | Zavation Medical Products, LLC | 2018 | — |
| +1 | K191354 | Ti3Z Cervical Interbody System | Zavation Medical Products, LLC | 2019 | — |
| +1 | K202398 | Ti3Z Cervical Interbody System | Zavation Medical Products, LLC | 2021 | — |
| +1 | K202305 | Zavation IBF System | Zavation Medical Products, LLC | 2020 | — |
| +1 | K200084 | Zavation IBF System | Zavation Medical Products, LLC | 2020 | — |
| +2 | K221049 | Zavation VariSync Plate System and VariSync Spacer System | Zavation Medical Products, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 7 | 0 |
| 2003 | 7 | 0 |
| 2004 | 9 | 0 |
| 2005 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 9 | 0 |
| 2009 | 6 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 0 |
| 2026 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K162206 | Zavation IBFSummary page 5…om medical grade PEEK Zeniva ZA-500 or Magnolia PEEK (ASTM F2026) with Tantalum alloy position markers (ASTM F560) or titanium per ASTM F136. Primary Predicate Device: K162206 Zavation IBF System [Zavation] Additional Predicate Device: K161407 Ascential IBD PEEKc Spacer [Stryker] K122097 Patriot® Spacer… | 2017 |
| * | K161407 | Ascential IBD PEEKc SpacerSummary page 5…h Tantalum alloy position markers (ASTM F560) or titanium per ASTM F136. Primary Predicate Device: K162206 Zavation IBF System [Zavation] Additional Predicate Device: K161407 Ascential IBD PEEKc Spacer [Stryker] K122097 Patriot® Spacers [Globus] Technological Characteristics: The Zavation IBF System po… | 2016 |
| * | K122097 | Patriot SpacersSummary page 5…or titanium per ASTM F136. Primary Predicate Device: K162206 Zavation IBF System [Zavation] Additional Predicate Device: K161407 Ascential IBD PEEKc Spacer [Stryker] K122097 Patriot® Spacers [Globus] Technological Characteristics: The Zavation IBF System possesses the same technological characteristic… | 2012 |
What descends from it? (22)
See all 227 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191354 | Ti3Z Cervical Interbody System | 2019 | 13 |
| K202398 | Ti3Z Cervical Interbody System | 2021 | 9 |
| K202305 | Zavation IBF System | 2020 | 9 |
| K200084 | Zavation IBF System | 2020 | 8 |
| K191339 | Zavation eZspand Interbody System | 2019 | 5 |
| K212811 | Ti3Z Lumbar Interbody System | 2022 | 3 |
| K190889 | Republic Spine Restore Cervical Interbody Fusion System | 2019 | 0 |
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 34 years and passes through 10 companies; a new generation was cleared every 1.3 years on median.
- 9 of the 83 ancestors have a recall of any class.
- Of its descendants, K191354 (Zavation Medical Products, LLC, 2019) has gone furthest, with 13 descendants of its own.
- 1 other device also cites its predicate K162206.
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. 2018, 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 indicated for spinal fusion procedures to be used with autogenous 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…
Read the full statement (230 words)
When used as a cervical intervertebral body fusion device, the Zavation IBF implants are indicated for spinal fusion procedures to be used with autogenous 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 indicated for spinal fusion procedures to be used with autogenous 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181246 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181246: Zavation IBF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181246
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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