510(k) · Cleared
ClearedTi 3Z 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 Jul 27, 2018 as substantially equivalent to K112664 (Zavation, LLC, 2011) and 2 other predicates after a 198-day review. Its family tree reaches back 19 generations to 1984. 4 later devices descend from it.
- Decided
- Jul 27, 2018
- Review
- 198 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 19 generations to K841189 (1984). 145 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations between
- 3 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 2 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 1 generation backK152304 Tritanium PL CageStryker · 2015 · Recalled
- This deviceK180076 Ti 3Z Interbody SystemZavation Medical Products, LLC · 2018
- Descendant · cites it directly · 3 of its ownK212811 Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC · 2022
- Descendant · 2 generations on · 2 of its ownK230731 Zavation ALIF SystemZavation Medical Products, LLC · 2023
- Descendant · 3 generations on · 1 of its ownK233509 Zavation IBF System, Zavation Varisync Plate System and Varisync…Zavation Medical Products, LLC · 2024
- Descendant · 4 generations on · 0 of its ownK250769 Dakota LP SystemPrecision Spine, Inc. · 2025
Show all 19 generations
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 17 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 16 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 13 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 12 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 9 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 8 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 7 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 6 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 5 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 4 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 3 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 2 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 1 generation backK152304 Tritanium PL CageStryker · 2015 · Recalled
- This deviceK180076 Ti 3Z Interbody SystemZavation Medical Products, LLC · 2018
Most influential descendants
Showing 4 of 4 · See all- K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC · 2022 · cites it directly3descendants
- K230731Zavation ALIF SystemZavation Medical Products, LLC · 2023 · 2 generations on2descendants
- K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC · 2024 · 3 generations on1descendant
- K250769Dakota LP SystemPrecision Spine, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −18 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −17 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −16 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −13 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −12 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −9 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −8 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −7 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −6 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −5 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −4 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −3 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −2 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −1 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| 0 (this device) | K180076 | Ti 3Z Interbody System | Zavation Medical Products, LLC | 2018 | — |
| +1 | K212811 | Ti3Z Lumbar Interbody System | Zavation Medical Products, LLC | 2022 | — |
| +2 | K230731 | Zavation ALIF System | Zavation Medical Products, LLC | 2023 | — |
| +3 | K233509 | Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer… | Zavation Medical Products, LLC | 2024 | — |
| +4 | K250769 | Dakota LP System | Precision Spine, 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 | 11 | 0 |
| 2004 | 17 | 0 |
| 2005 | 9 | 0 |
| 2006 | 2 | 0 |
| 2007 | 8 | 0 |
| 2008 | 20 | 0 |
| 2009 | 12 | 0 |
| 2010 | 9 | 0 |
| 2011 | 8 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 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.
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 |
|---|---|---|---|
| * | K112664 | Zavation Ibf SystemsSummary page 5…crew System. Materials: The devices are manufactured from medical grade Titanium Ti64ELI (ASTM F3001-14). Predicate Device: Primary -Zavation IBF System, Zavation LLC (K112664) Additional – Stryker Spine Tritanium® PL Cage (K152304) Additional – K122097 Globus Medical Patriot® Spacers (Continental™ ALIF… | 2011 |
| * | K152304 | Tritanium PL CageSummary page 5…om medical grade Titanium Ti64ELI (ASTM F3001-14). Predicate Device: Primary -Zavation IBF System, Zavation LLC (K112664) Additional – Stryker Spine Tritanium® PL Cage (K152304) Additional – K122097 Globus Medical Patriot® Spacers (Continental™ ALIF and TransContinental®) Technological Characteristics: T… | 2015 |
| * | K122097 | Patriot SpacersSummary page 5…ium Ti64ELI (ASTM F3001-14). Predicate Device: Primary -Zavation IBF System, Zavation LLC (K112664) Additional – Stryker Spine Tritanium® PL Cage (K152304) Additional – K122097 Globus Medical Patriot® Spacers (Continental™ ALIF and TransContinental®) Technological Characteristics: The Zavation Ti 3Z Inte… | 2012 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212811 | Ti3Z Lumbar Interbody System | 2022 | 3 |
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 13 companies; a new generation was cleared every 10 months on median.
- 17 of the 145 ancestors have a recall of any class.
- Of its descendants, K212811 (Zavation Medical Products, LLC, 2022) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K112664.
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 lumbar intervertebral body fusion device, the Zavation Ti 3Z Interbody System 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…
Read the full statement (139 words)
When used as a lumbar intervertebral body fusion device, the Zavation Ti 3Z Interbody System 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 Ti 3Z Interbody implants are intended to be used with supplemental internal
fixation appropriate for the implanted level, including Zavation Pedicle Screw System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180076 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180076: Ti 3Z Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180076
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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