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 Oct 19, 2020 as substantially equivalent to K181246 (Zavation Medical Products, LLC, 2018) and 1 other predicate after a 278-day review. Its family tree reaches back 16 generations to 1984. 8 later devices descend from it.
- Decided
- Oct 19, 2020
- Review
- 278 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 16 generations to K841189 (1984). 91 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations between
- 3 generations backK120576 Zavation Ibf SystemZavation, LLC · 2012
- 2 generations backK162206 Zavation IBFZavation, LLC · 2017
- 1 generation backK181246 Zavation IBF SystemZavation Medical Products, LLC · 2018
- This deviceK200084 Zavation IBF SystemZavation Medical Products, LLC · 2020
- Descendant · cites it directly · 4 of its ownK220581 Zavation eZspand Interbody SystemZavation Medical Products, LLC · 2022
- Descendant · 2 generations on · 3 of its ownK223174 X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc. · 2023
- Descendant · cites it directly · 2 of its ownK230731 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 16 generations
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 14 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 13 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 10 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 9 generations backK051454 Aleutian Spacer SystemK2m, LLC · 2005
- 8 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- 7 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- 6 generations backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
- 5 generations backK110843 Aleutian Spacer SystemK2m, Inc. · 2011
- 4 generations backK112664 Zavation Ibf SystemsZavation, LLC · 2011
- 3 generations backK120576 Zavation Ibf SystemZavation, LLC · 2012
- 2 generations backK162206 Zavation IBFZavation, LLC · 2017
- 1 generation backK181246 Zavation IBF SystemZavation Medical Products, LLC · 2018
- This deviceK200084 Zavation IBF SystemZavation Medical Products, LLC · 2020
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC · 2022 · cites it directly4descendants
- K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc. · 2023 · 2 generations on3descendants
- K230731Zavation ALIF SystemZavation Medical Products, LLC · 2023 · cites it directly2descendants
- K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC · 2024 · cites it directly1descendant
- K250769Dakota LP SystemPrecision Spine, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −15 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −14 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −13 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −10 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −9 | K051454 | Aleutian Spacer System | K2m, LLC | 2005 | — |
| −8 | K063399 | Aleutian Spacer System | K2m, Inc. | 2007 | — |
| −7 | K082698 | Aleutian Ibf System | K2m, Inc. | 2009 | — |
| −6 | K101302 | Aleutian Ibf System | K2m, Inc. | 2010 | — |
| −5 | K110843 | Aleutian Spacer System | K2m, Inc. | 2011 | — |
| −4 | K112664 | Zavation Ibf Systems | Zavation, LLC | 2011 | — |
| −3 | K120576 | Zavation Ibf System | Zavation, LLC | 2012 | — |
| −2 | K162206 | Zavation IBF | Zavation, LLC | 2017 | — |
| −1 | K181246 | Zavation IBF System | Zavation Medical Products, LLC | 2018 | — |
| 0 (this device) | K200084 | Zavation IBF System | Zavation Medical Products, LLC | 2020 | — |
| +1 | K220581 | Zavation eZspand Interbody System | Zavation Medical Products, LLC | 2022 | — |
| +2 | K223174 | X-Pac Expandable LLIF Cage System | Expanding Innovations, Inc. | 2023 | — |
| +1 | 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 |
|---|---|---|
| 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 | 5 | 0 |
| 2008 | 9 | 0 |
| 2009 | 7 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 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? (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 |
|---|---|---|---|
| * | K181246 | Zavation IBF SystemSummary 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: K181246 Zavation IBF System [Zavation] Additional Predicate Device: K150061 Lucent Ti-Bond® [Spinal Elements] Additional References: K1… | 2018 |
| * | K150061 | Lucent; Lucent Ti-Bond SystemsSummary page 5…plasma coating is made from commercially pure titanium per (ASTM F1580). Primary Predicate Device: K181246 Zavation IBF System [Zavation] Additional Predicate Device: K150061 Lucent Ti-Bond® [Spinal Elements] Additional References: K180076 Zavation Ti-3Z IBF System TLIF [Zavation] K122097 Globus Medica… | 2015 |
| † | K180076 | Ti 3Z Interbody System | 2018 |
| † | K122097 | Patriot Spacers | 2012 |
What descends from it? (8)
3 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 36 years and passes through 10 companies; a new generation was cleared every 1.3 years on median.
- 10 of the 91 ancestors have a recall of any class.
- Of its descendants, K220581 (Zavation Medical Products, LLC, 2022) has gone furthest, with 4 descendants of its own.
- 6 other devices also cite its predicate K181246.
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. 2020, 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 (242 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200084 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200084: 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/K200084
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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