510(k) · Cleared
ClearedZavation eZspand Interbody 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 Aug 19, 2019 as substantially equivalent to K172696 (Orthofix, Inc., 2018) and 2 other predicates after a 91-day review. Its family tree reaches back 20 generations to 1984. 1 of the 191 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Aug 19, 2019
- Review
- 91 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 20 generations to K841189 (1984). 185 ancestors in all. 5 later devices descend from it, 1 citing it directly. 1 of the 191 devices in this family, counting this one, has a Class I recall.
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations between
- 3 generations backK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
- 2 generations backK162918 Atlas Spine Expandable Interbody SystemAtlas Spine, Inc. · 2017
- 1 generation backK172696 FORZA® XP Expandable Spacer SystemOrthofix, Inc. · 2018
- This deviceK191339 Zavation eZspand Interbody SystemZavation Medical Products, LLC · 2019
- 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 · 3 generations on · 0 of its ownK251003 X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK251617 X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable…Expanding Innovations, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK250602 X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc. · 2025
Show all 20 generations
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 19 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 18 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 17 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 16 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 14 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 13 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 12 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 10 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 9 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 8 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 7 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 6 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 5 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 4 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 3 generations backK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
- 2 generations backK162918 Atlas Spine Expandable Interbody SystemAtlas Spine, Inc. · 2017
- 1 generation backK172696 FORZA® XP Expandable Spacer SystemOrthofix, Inc. · 2018
- This deviceK191339 Zavation eZspand Interbody SystemZavation Medical Products, LLC · 2019
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
Most influential descendants
Showing 5 of 5 · 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
- K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc. · 2025 · 3 generations on0descendants
- K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc. · 2025 · 3 generations on0descendants
- K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −19 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −18 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −17 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −16 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −14 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −13 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −12 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −10 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −9 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −8 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| −7 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| −6 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| −5 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| −4 | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | Centinel Spine, Inc. | 2015 | — |
| −3 | K152475 | FORZA PTC Spacer System | Orthofix, Inc. | 2016 | — |
| −2 | K162918 | Atlas Spine Expandable Interbody System | Atlas Spine, Inc. | 2017 | — |
| −1 | K172696 | FORZA® XP Expandable Spacer System | Orthofix, Inc. | 2018 | — |
| 0 (this device) | K191339 | Zavation eZspand Interbody System | Zavation Medical Products, LLC | 2019 | — |
| +1 | K220581 | Zavation eZspand Interbody System | Zavation Medical Products, LLC | 2022 | — |
| +2 | K223174 | X-Pac Expandable LLIF Cage System | Expanding Innovations, Inc. | 2023 | — |
| +3 | K251003 | X-PAC® LLIF Expandable Lateral Cage System | Expanding Innovations, Inc. | 2025 | — |
| +3 | K251617 | X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral… | Expanding Innovations, Inc. | 2025 | — |
| +3 | K250602 | X-PAC® N-GAGE™ Lumbar Plate System | Expanding Innovations, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 13 | 0 |
| 2004 | 16 | 0 |
| 2005 | 15 | 0 |
| 2006 | 4 | 0 |
| 2007 | 11 | 0 |
| 2008 | 26 | 1 |
| 2009 | 14 | 0 |
| 2010 | 12 | 0 |
| 2011 | 10 | 0 |
| 2012 | 6 | 0 |
| 2013 | 5 | 0 |
| 2014 | 6 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 3 | 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? (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 |
|---|---|---|---|
| * | K172696 | FORZA® XP Expandable Spacer SystemSummary page 5…tem. Materials: The Zavation eZspand™ Interbody System components are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136. Primary Predicate Device: K172696 Forza XP Expandable Spacer System [Orthofix] Additional Predicate Devices: K181246 Zavation IBF System [Zavation] K142271 Zavati… | 2018 |
| * | K181246 | Zavation IBF SystemSummary page 5…from titanium alloy (Ti-6Al-4V) as described by ASTM F136. Primary Predicate Device: K172696 Forza XP Expandable Spacer System [Orthofix] Additional Predicate Devices: K181246 Zavation IBF System [Zavation] K142271 Zavation Z-Link Lumbar [Zavation] Technological Characteristics: The Zavation eZspand™ In… | 2018 |
| * | K142271 | Zavation Z-Link LumbarSummary page 5…ribed by ASTM F136. Primary Predicate Device: K172696 Forza XP Expandable Spacer System [Orthofix] Additional Predicate Devices: K181246 Zavation IBF System [Zavation] K142271 Zavation Z-Link Lumbar [Zavation] Technological Characteristics: The Zavation eZspand™ Interbody System possesses the same techn… | 2014 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220581 | Zavation eZspand Interbody System | 2022 | 4 |
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 · 5 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 35 years and passes through 16 companies; a new generation was cleared every 1.0 years on median.
- 24 of the 185 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K220581 (Zavation Medical Products, LLC, 2022) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K172696.
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. 2019, 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?
The Zavation eZspand™ PLIF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The Zavation eZspand PLIF 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…
Read the full statement (122 words)
The Zavation eZspand™ PLIF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The Zavation eZspand PLIF 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.
The Zavation eZspand™ PLIF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Spinal System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191339 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191339: Zavation eZspand Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191339
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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