510(k) · Cleared
ClearedZyston Strut Open Titanium Spacer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Biomet Spine, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Feb 12, 2018 as substantially equivalent to K143258 (4Web, Inc., 2015) and 2 other predicates after a 266-day review. Its family tree reaches back 21 generations to 1984. 1 of the 171 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Feb 12, 2018
- Review
- 266 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 21 generations to K841189 (1984). 169 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 171 devices in this family, counting this one, has a Class I recall.
- Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations between
- 3 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 2 generations backK160955 Tritanium® PL CageStryker · 2016
- 1 generation backK162262 Tritanium® PL CageStryker · 2016
- This deviceK171495 Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK251479 Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar…Mobarn Medical Devices, LLC · 2025
Show all 21 generations
- Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 20 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 19 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 18 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 16 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 15 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 14 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 12 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 11 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 10 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 9 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 8 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 7 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 6 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 5 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 4 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 3 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 2 generations backK160955 Tritanium® PL CageStryker · 2016
- 1 generation backK162262 Tritanium® PL CageStryker · 2016
- This deviceK171495 Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc. · 2018
Class I recalls in this family
- K073202 Ardis Spacer3 generations back · 2008
Most influential descendants
Showing 1 of 1 · See all- K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −20 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −19 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −18 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −16 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −15 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −14 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −12 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −11 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −10 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −9 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −8 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −7 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −6 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −5 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −4 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −3 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −2 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −1 | K162262 | Tritanium® PL Cage | Stryker | 2016 | — |
| 0 (this device) | K171495 | Zyston Strut Open Titanium Spacer System | Zimmer Biomet Spine, Inc. | 2018 | — |
| +1 | K251479 | Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion… | Mobarn Medical Devices, LLC | 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 | 17 | 0 |
| 2005 | 10 | 0 |
| 2006 | 3 | 0 |
| 2007 | 10 | 0 |
| 2008 | 25 | 1 |
| 2009 | 13 | 0 |
| 2010 | 7 | 0 |
| 2011 | 12 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 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? (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 |
|---|---|---|---|
| * | K143258 | PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)Summary page 4…r Product Code MAX Device Panel – Regulation No. Orthopedic – 21 CFR 888.3080 Primary Predicate K143258 - 4Web Spine Truss System (STS) Additional Predicates K162262 – Stryker Tritnaium PL Cage, K153695 – Biome… | 2015 |
| * | K162262 | Tritanium® PL CageSummary page 4…Orthopedic – 21 CFR 888.3080 Primary Predicate K143258 - 4Web Spine Truss System (STS) Additional Predicates K162262 – Stryker Tritnaium PL Cage, K153695 – Biomet Spine Fusion System Device Descriptio… | 2016 |
| * | K153695 | Biomet Spine Fusion SystemSummary page 4…80 Primary Predicate K143258 - 4Web Spine Truss System (STS) Additional Predicates K162262 – Stryker Tritnaium PL Cage, K153695 – Biomet Spine Fusion System Device Description & Technological Characteristics: Th… | 2016 |
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 |
|---|---|---|---|
| K251479 | Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage… | 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 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 11 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 9 months on median.
- 23 of the 169 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K251479 (Mobarn Medical Devices, LLC, 2025) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K143258.
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 Zyston Strut Open Titanium Interbody Spacer System is intended for spinal fusion procedures to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft in skeletally mature patients with degenerative disc disease (“DDD”) at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc…
Read the full statement (150 words)
When used as a lumbar intervertebral body fusion device, the Zyston Strut Open Titanium Interbody Spacer System is intended for spinal fusion procedures to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft in skeletally mature patients with degenerative disc disease (“DDD”) at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Zyston Strut Open Titanium Interbody Spacer System is to be implanted via a posterior approach and is to be combined with supplemental fixation. The titanium fusion devices are not indicated for vertebral body replacement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171495 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171495: Zyston Strut Open Titanium Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171495
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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