510(k) Report

510(k) · Cleared

Cleared

Zyston Straight Spacer System

K112014510(k) TraditionalCleared Oct 17, 201195-day reviewClass II21 CFR 888.3080

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biomet Spine · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Oct 17, 2011 as substantially equivalent to K091381 (Ebi, L.P., 2009) and 9 other predicates after a 95-day review. Its family tree reaches back 8 generations to 2001. 174 later devices descend from it.

Decided
Oct 17, 2011
Review
95 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
10

Its longest line of descent runs back 8 generations to K003155 (2001). 44 ancestors in all, the oldest K841189 (1984). 174 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 1 other ancestor2009: 2 other ancestors2008: 5 other ancestors2005: 1 other ancestor2004: 6 other ancestors2007: 2 other ancestors2006: 1 other ancestor2003: 2 other ancestors2002: 4 other ancestors2001: 6 other ancestors1999: 2 other ancestors1996: 2 other ancestors2000: 1 other ancestor1984: 1 other ancestor2012: 1 descendant cleared2017: 5 descendants cleared2024: 29 descendants cleared2016: 2 descendants cleared2021: 14 descendants cleared2019: 12 descendants cleared2020: 12 descendants cleared2023: 22 descendants cleared2022: 16 descendants cleared2018: 4 descendants cleared2026: 28 descendants cleared2025: 29 descendants clearedK003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001K012254 · VBR · Osteotech, Inc. · 2001×2: 2 generations cleared close together, K021791 (2002), K023570 (2002) K031780 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2003K040731 · Stryker Spine Vertebral Spacer · Stryker Spine · 2004×2: 2 generations cleared close together, K042571 (2005), K050624 (2005) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 9 other ancestors2 generations back: 12 other ancestors3 generations back: 10 other ancestors4 generations back: 4 other ancestors5 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 3 descendants4 generations forward: 9 descendants5 generations forward: 22 descendants6 generations forward: 25 descendants7 generations forward: 13 descendants8 generations forward: 8 descendants9 generations forward: 13 descendants10 generations forward: 24 descendants11 generations forward: 29 descendants12 generations forward: 16 descendants13 generations forward: 6 descendants14 generations forward: 1 descendant K050624 · Stryker Spine Avs PL Peek Spacer · Stryker Spine · 2005K042571 · Stryker Spine Avs TL Peek Spacer · Stryker Spine · 2005K040731 · Stryker Spine Vertebral Spacer · Stryker Spine · 2004K031780 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2003K023570 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K021791 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K012254 · VBR · Osteotech, Inc. · 2001K003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001−50+5+10
  1. Root · 8 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 7 generations backK012254 VBROsteotech, Inc. · 2001
  3. 6 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 5 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 4 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 3 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
  7. 2 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
  8. 1 generation backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
  9. This deviceK112014 Zyston Straight Spacer SystemBiomet Spine · 2011
  10. Descendant · cites it directly · 171 of its ownK122989 Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC) · 2012
  11. Descendant · 2 generations on · 169 of its ownK151310 Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
  12. Descendant · 3 generations on · 166 of its ownK160924 Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
  13. Descendant · 4 generations on · 129 of its ownK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
  14. Descendant · 5 generations on · 106 of its ownK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018

Showing 5 of 174 descendants. See all descendants

Descendants cleared per year

2012: 12016: 22017: 52018: 42019: 122020: 122021: 142022: 162023: 222024: 292025: 292026: 28
2012high 29 (2024) · low 0 (2013)2026

Most influential descendants

Showing 5 of 174 · See all
  • K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC) · 2012 · cites it directly171descendants
  • K151310Amendia Interbody Fusion DevicesAmendia, Inc. · 2016 · 2 generations on169descendants
  • K160924Amendia Interbody Fusion DevicesAmendia, Inc. · 2016 · 3 generations on166descendants
  • K171496Tritanium C Anterior Cervical CageStryker Spine · 2017 · 4 generations on129descendants
  • K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018 · 5 generations on106descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−7K012254VBROsteotech, Inc.2001—
−6K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−5K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−4K031780Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−3K040731Stryker Spine Vertebral SpacerStryker Spine2004—
−2K042571Stryker Spine Avs TL Peek SpacerStryker Spine2005—
−1K050624Stryker Spine Avs PL Peek SpacerStryker Spine2005—
0 (this device)K112014Zyston Straight Spacer SystemBiomet Spine2011—
+1K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012—
+2K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016—
+3K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016—
+4K171496Tritanium C Anterior Cervical CageStryker Spine2017—
+5K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199620
199920
200010
200160
200240
200320
200460
200510
200610
200720
200850
200920
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201620
201750
201840
2019120
2020120
2021140
2022160
2023220
2024290
2025290
2026280
FIG. 1 — Lineage of K112014, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (10)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K091381Ibex Spinal System
Summary page 2
…zing) of the Zyston Straight Spacer System is the same as, or similar to, the predicate devices. Examples of predicate devices include: * Ibex Spinal Spacer System (K091381, K050861) * Expandable PEEK Implant (K082406, K040928) * ESL Spacer (K092574, K040482) * Novel LCC Spacer System (…
Ebi, L.P.2009—
*K050861Peek Cas
Summary page 2
…the Zyston Straight Spacer System is the same as, or similar to, the predicate devices. Examples of predicate devices include: * Ibex Spinal Spacer System (K091381, K050861) * Expandable PEEK Implant (K082406, K040928) * ESL Spacer (K092574, K040482) * Novel LCC Spacer System (K080699)…
Interpore Cross Intl.2005—
*K082406Expandable Peek-Optima Implant
Summary page 2
…same as, or similar to, the predicate devices. Examples of predicate devices include: * Ibex Spinal Spacer System (K091381, K050861) * Expandable PEEK Implant (K082406, K040928) * ESL Spacer (K092574, K040482) * Novel LCC Spacer System (K080699) * AVS PL PEEK Spacer System (K050624…
Ebi, L.P.2009—
*K040928Expandable Peek VBR Implant
Summary page 2
…or similar to, the predicate devices. Examples of predicate devices include: * Ibex Spinal Spacer System (K091381, K050861) * Expandable PEEK Implant (K082406, K040928) * ESL Spacer (K092574, K040482) * Novel LCC Spacer System (K080699) * AVS PL PEEK Spacer System (K050624, K073470…
Interpore Cross Intl.2004—
*K092574Esl Spinal System
Summary page 2
…devices. Examples of predicate devices include: * Ibex Spinal Spacer System (K091381, K050861) * Expandable PEEK Implant (K082406, K040928) * ESL Spacer (K092574, K040482) * Novel LCC Spacer System (K080699) * AVS PL PEEK Spacer System (K050624, K073470, K0820 14) Performance Dat…
Ebi, L.P.2010—
*K040482Ebi Esl Spine Spacer System
Summary page 2
…Examples of predicate devices include: * Ibex Spinal Spacer System (K091381, K050861) * Expandable PEEK Implant (K082406, K040928) * ESL Spacer (K092574, K040482) * Novel LCC Spacer System (K080699) * AVS PL PEEK Spacer System (K050624, K073470, K0820 14) Performance Data Mechani…
Ebi, L.P.2004—
*K080699Novel Spinal Spacer System
Summary page 2
…* Ibex Spinal Spacer System (K091381, K050861) * Expandable PEEK Implant (K082406, K040928) * ESL Spacer (K092574, K040482) * Novel LCC Spacer System (K080699) * AVS PL PEEK Spacer System (K050624, K073470, K0820 14) Performance Data Mechanical testing recommended in the special co…
Alphatec Spine, Inc.20081
*K050624Stryker Spine Avs PL Peek Spacer
Summary page 2
…050861) * Expandable PEEK Implant (K082406, K040928) * ESL Spacer (K092574, K040482) * Novel LCC Spacer System (K080699) * AVS PL PEEK Spacer System (K050624, K073470, K0820 14) Performance Data Mechanical testing recommended in the special controls guidance document entitled "Class II…
Stryker Spine2005—
*K073470Avs PL Peek Spacers, Models 48351XXX and 48353XXX
Summary page 2
…* Expandable PEEK Implant (K082406, K040928) * ESL Spacer (K092574, K040482) * Novel LCC Spacer System (K080699) * AVS PL PEEK Spacer System (K050624, K073470, K0820 14) Performance Data Mechanical testing recommended in the special controls guidance document entitled "Class II Special…
Stryker Spine2008—
*K082014Stryker Spine Avs PL Peek Spacers
Summary page 2
…andable PEEK Implant (K082406, K040928) * ESL Spacer (K092574, K040482) * Novel LCC Spacer System (K080699) * AVS PL PEEK Spacer System (K050624, K073470, K0820 14) Performance Data Mechanical testing recommended in the special controls guidance document entitled "Class II Special Controls G…
Stryker Corp.2008—

Also cleared against K091381: 1 other device →

What descends from it? (174)

See all 174

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171
K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.20171

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 10 years and passes through 4 companies; a new generation was cleared every 9 months on median.
  • 6 of the 44 ancestors have a recall of any class.
  • Of its descendants, K122989 (Biomet Spine (Aka Ebi, LLC), 2012) has gone furthest, with 171 descendants of its own.
  • 1 other device also cites its predicate K091381.

How does its category compare?

All MAX devices

MAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · MAX

29in 2025

2007: 72008: 352009: 312010: 292011: 492012: 482013: 582014: 582015: 532016: 642017: 762018: 642019: 602020: 562021: 532022: 412023: 302024: 382025: 292026 (partial year): 18
2007high 76 (2017) · low 7 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAX

85in 2025

2007: 86 days median2008: 88 days median2009: 102 days median2010: 137 days median2011: 98 days median2012: 69 days median2013: 102 days median2014: 115 days median2015: 113 days median2016: 124 days median2017: 116 days median2018: 114 days median2019: 131 days median2020: 106 days median2021: 109 days median2022: 95 days median2023: 87 days median2024: 91 days median2025: 85 days median2026 (partial year): 95 days median
2007high 137 (2010) · low 69 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MAX

5in 2025

2008: 22009: 92011: 32012: 11, 1 Class I2014: 32015: 12016: 62017: 12018: 42019: 12022: 12024: 12025: 5
2007high 11 (2012) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MAX

811in 2025

2007: 122008: 192009: 902010: 1542011: 2012012: 3272013: 3802014: 3662015: 5242016: 6472017: 5962018: 6162019: 6992020: 6402021: 6222022: 6182023: 5762024: 7292025: 811
2007high 811 (2025) · low 12 (2007)2025

MAUDE reports naming product code MAX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007786012
20083588219
200931102990
2010291370154
201149983201
2012486911 (1)327
2013581020380
2014581153366
2015531131524
2016641246647
2017761161596
2018641144616
2019601311699
2020561060640
2021531090622
202241951618
202330870576
202438911729
202529855811
202618950—

What is it indicated for?

The Zyston Straight Spacer System is indicated for vertebral body replacement and intervertebral body fusion. When used for vertebral body replacement, the Zyston Straight Spacer System is indicated for use in the thoracolumbar spine (i.e., T1 - L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height…

Read the full statement (310 words)

The Zyston Straight Spacer System is indicated for vertebral body replacement and intervertebral body fusion. When used for vertebral body replacement, the Zyston Straight Spacer System is indicated for use in the thoracolumbar spine (i.e., T1 - L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Zyston Straight Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The Zyston Straight Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. When used for vertebral body replacement, the Zyston Straight Spacer System is designed for use with bone graft and is intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.

As an intervertebral body fusion device, the Zyston Straight Spacer System is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. When used as an intervertebral body fusion device, the Zyston Straight Spacer System is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

The Zyston Straight Spacer System may also be implanted using the AccuVision System to provide the surgeon with a minimally invasive approach for posterior or posterolateral spinal surgery.

Indications for use as stated in the FDA summary.

Also cleared against K091381

1 other device cites the same predicate.

  • K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC) · 2011

More from Biomet Spine

19 FDA decisions under this applicant name. See the company

  • K152622Alta ACDF SystemBiomet Spine · 2016
  • K151974Polaris Spinal SystemBiomet Spine · 2015
  • K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body…Biomet Spine · 2015
  • K151224Lineum OCT Spine SystemBiomet Spine · 20151 recall
  • K141791Biomet Fusion SystemBiomet Spine · 2014

Recent decisions in MAX

The MAX category page

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  • K261049Scala® TLSpineart SA · 2026
  • K261430TruLift Expandable SystemLife Spine, Inc. · 2026
  • K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2026
  • K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2026

https://510kreport.com/device/K112014 · printed Nov 3, 2026

Cite this page

510(k) Report. “K112014: Zyston Straight Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112014

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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