510(k) · Cleared
ClearedZyston Arc Interbody Spacer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Spine (Aka Ebi, LLC) · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jun 30, 2011 as substantially equivalent to K091381 (Ebi, L.P., 2009) and 4 other predicates after a 118-day review. Its family tree reaches back 10 generations to 1984. 177 later devices descend from it.
- Decided
- Jun 30, 2011
- Review
- 118 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K841189 (1984). 41 ancestors in all. 177 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 6 generations between
- 3 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 1 generation backK080401 Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG · 2008
- This deviceK110650 Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC) · 2011
- Descendant · cites it directly · 171 of its ownK122989 Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC) · 2012
- Descendant · 2 generations on · 169 of its ownK151310 Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
- Descendant · 3 generations on · 166 of its ownK160924 Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
- Descendant · 4 generations on · 129 of its ownK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- Descendant · 5 generations on · 106 of its ownK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
Show all 10 generations
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 8 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 7 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 5 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 4 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 3 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 1 generation backK080401 Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG · 2008
- This deviceK110650 Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC) · 2011
Showing 5 of 177 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 177 · 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −9 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −8 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −7 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −5 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −4 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −3 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −2 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −1 | K080401 | Shell Cage, Wave Cage, Loop Cage | Advanced Medical Technologies AG | 2008 | — |
| 0 (this device) | K110650 | Zyston Arc Interbody Spacer | Biomet Spine (Aka Ebi, LLC) | 2011 | — |
| +1 | K122989 | Biomet Lateral Spacer System | Biomet Spine (Aka Ebi, LLC) | 2012 | — |
| +2 | K151310 | Amendia Interbody Fusion Devices | Amendia, Inc. | 2016 | — |
| +3 | K160924 | Amendia Interbody Fusion Devices | Amendia, Inc. | 2016 | — |
| +4 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| +5 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 6 | 0 |
| 2018 | 5 | 0 |
| 2019 | 13 | 0 |
| 2020 | 12 | 0 |
| 2021 | 13 | 0 |
| 2022 | 16 | 0 |
| 2023 | 22 | 0 |
| 2024 | 29 | 0 |
| 2025 | 29 | 0 |
| 2026 | 28 | 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? (5)
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 |
|---|---|---|---|
| * | K091381 | Ibex Spinal SystemSummary page 2…ign and sizing) of the Zyston Curve Spacer is the same as, or similar to, the predicate devices. Examples of predicate devices include: " Ibex Spinal Spacer System (K0913 81) * Expandable PEEK Implant (K082406) * ESL Spacer (K092574) * Sig-nature Tm TLIF Spacer (K072970) " LoopTM In… | 2009 |
| * | K082406 | Expandable Peek-Optima ImplantSummary page 2…is the same as, or similar to, the predicate devices. Examples of predicate devices include: " Ibex Spinal Spacer System (K0913 81) * Expandable PEEK Implant (K082406) * ESL Spacer (K092574) * Sig-nature Tm TLIF Spacer (K072970) " LoopTM Interbody Fusion Device (K080401) Perform… | 2009 |
| * | K092574 | Esl Spinal SystemSummary page 2…to, the predicate devices. Examples of predicate devices include: " Ibex Spinal Spacer System (K0913 81) * Expandable PEEK Implant (K082406) * ESL Spacer (K092574) * Sig-nature Tm TLIF Spacer (K072970) " LoopTM Interbody Fusion Device (K080401) Performance Data Mechanical testing… | 2010 |
| * | K072970 | Patriot SpacersSummary page 2…icate devices include: " Ibex Spinal Spacer System (K0913 81) * Expandable PEEK Implant (K082406) * ESL Spacer (K092574) * Sig-nature Tm TLIF Spacer (K072970) " LoopTM Interbody Fusion Device (K080401) Performance Data Mechanical testing recommended in the special controls guidan… | 2008 |
| * | K080401 | Shell Cage, Wave Cage, Loop CageSummary page 2…System (K0913 81) * Expandable PEEK Implant (K082406) * ESL Spacer (K092574) * Sig-nature Tm TLIF Spacer (K072970) " LoopTM Interbody Fusion Device (K080401) Performance Data Mechanical testing recommended in the special controls guidance document entitled "Class 11 Special Controls… | 2008 |
What descends from it? (177)
See all 1773 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 27 years and passes through 9 companies; a new generation was cleared every 1.7 years on median.
- 5 of the 41 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 devicesMAX 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
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 Zyston Curve Interbody 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…
Read the full statement (139 words)
The Zyston Curve Interbody 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.
The Zyston Curve Interbody 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 Curve Interbody 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.
https://510kreport.com/device/K110650 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110650: Zyston Arc Interbody Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110650
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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