510(k) · Cleared
ClearedZSAlign Cervical Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ZSFab, Inc. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Jul 31, 2026 as substantially equivalent to K212904 (SeaSpine Orthopedics Corporation, 2021) and 2 other predicates after a 91-day review. Its family tree reaches back 28 generations to 1984. 1 of the 734 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 31, 2026
- Review
- 91 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 28 generations to K841189 (1984). 733 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet. 1 of the 734 devices in this family, counting this one, has a Class I recall.
- Root · 28 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 24 generations between
- 3 generations backK231766 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2023
- 2 generations backK243015 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc. · 2024
- 1 generation backK250486 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2025
- This deviceK261451 ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026
Show all 28 generations
- Root · 28 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 27 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 26 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 25 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 24 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 23 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 22 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 21 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 20 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 19 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 18 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 17 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 16 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 15 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 14 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 13 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 12 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 11 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 10 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 9 generations backK160125 Cascadia Interbody SystemK2m · 2016
- 8 generations backK162264 Cascadia Interbody SystemK2m, Inc. · 2016
- 7 generations backK172941 CASCADIA Interbody SystemK2m · 2018
- 6 generations backK191354 Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2019
- 5 generations backK202305 Zavation IBF SystemZavation Medical Products, LLC · 2020
- 4 generations backK221049 Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC · 2022
- 3 generations backK231766 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2023
- 2 generations backK243015 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc. · 2024
- 1 generation backK250486 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2025
- This deviceK261451 ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026
Class I recalls in this family
- K073202 Ardis Spacer6 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −28 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −27 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −26 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −25 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −24 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −23 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −22 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −21 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −20 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −19 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −18 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −17 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −16 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −15 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −14 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −13 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −12 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −11 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −10 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −9 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| −8 | K162264 | Cascadia Interbody System | K2m, Inc. | 2016 | — |
| −7 | K172941 | CASCADIA Interbody System | K2m | 2018 | — |
| −6 | K191354 | Ti3Z Cervical Interbody System | Zavation Medical Products, LLC | 2019 | — |
| −5 | K202305 | Zavation IBF System | Zavation Medical Products, LLC | 2020 | — |
| −4 | K221049 | Zavation VariSync Plate System and VariSync Spacer System | Zavation Medical Products, LLC | 2022 | — |
| −3 | K231766 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | 2023 | — |
| −2 | K243015 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies, Inc. | 2024 | — |
| −1 | K250486 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | 2025 | — |
| 0 (this device) | K261451 | ZSAlign Cervical Interbody System | ZSFab, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 7 | 0 |
| 1997 | 7 | 0 |
| 1998 | 6 | 0 |
| 1999 | 8 | 0 |
| 2000 | 13 | 0 |
| 2001 | 17 | 0 |
| 2002 | 16 | 0 |
| 2003 | 25 | 0 |
| 2004 | 39 | 0 |
| 2005 | 32 | 0 |
| 2006 | 24 | 0 |
| 2007 | 27 | 0 |
| 2008 | 58 | 1 |
| 2009 | 47 | 0 |
| 2010 | 36 | 0 |
| 2011 | 57 | 0 |
| 2012 | 37 | 0 |
| 2013 | 35 | 0 |
| 2014 | 49 | 0 |
| 2015 | 38 | 0 |
| 2016 | 32 | 0 |
| 2017 | 32 | 0 |
| 2018 | 13 | 0 |
| 2019 | 12 | 0 |
| 2020 | 9 | 0 |
| 2021 | 7 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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 OVE device
- #1 K241846 E3D™-C Interbody Systemscore 32.1 · 32 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 |
|---|---|---|---|
| * | K212904 | SeaSpine WaveForm C Interbody SystemSummary page 6…Manufacturing and Biocompatibility Predicate Devices 510k Number Trade or Proprietary or Model Name Manufacturer Product Code Predicate Type K212904 SeaSpine WaveForm C Interbody SeaSpine Orthopedics OVE, ODP Primary System… | 2021 |
| * | K242734 | ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemSummary page 6…Product Code Predicate Type K212904 SeaSpine WaveForm C Interbody SeaSpine Orthopedics OVE, ODP Primary System K242734 ZSFab Cervical Interbody System ZSFab, Inc. ODP, MAX Additional K250486 Skywa… | 2024 |
| * | K250486 | Skyway Anterior Cervical Plate SystemSummary page 6…s OVE, ODP Primary System K242734 ZSFab Cervical Interbody System ZSFab, Inc. ODP, MAX Additional K250486 Skyway Anterior Cervical Plate System Kyocera Medical OVE, KWQ Additional… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 6 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 42 years and passes through 18 companies; a new generation was cleared every 1.0 years on median.
- 83 of the 733 ancestors have a recall of any class; 1 has a Class I recall.
- 5 other devices also cite its predicate K212904.
How does its category compare?
All OVE devicesOVE Intervertebral Fusion Device With Integrated Fixation, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · OVE
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVE
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVE
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVE
132in 2025
MAUDE reports naming product code OVE, 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 | 1 | — | 0 | 0 |
| 2008 | 4 | 131 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 210 | 0 | 2 |
| 2011 | 8 | 139 | 0 | 19 |
| 2012 | 7 | 125 | 0 | 59 |
| 2013 | 5 | 71 | 1 | 250 |
| 2014 | 11 | 168 | 1 | 150 |
| 2015 | 12 | 113 | 1 | 173 |
| 2016 | 15 | 149 | 1 | 145 |
| 2017 | 9 | 100 | 1 | 134 |
| 2018 | 7 | 105 | 0 | 210 |
| 2019 | 7 | 87 | 0 | 169 |
| 2020 | 13 | 149 | 0 | 162 |
| 2021 | 10 | 93 | 2 | 186 |
| 2022 | 10 | 144 | 0 | 200 |
| 2023 | 16 | 97 | 0 | 148 |
| 2024 | 6 | 56 | 0 | 142 |
| 2025 | 10 | 105 | 0 | 132 |
| 2026 | 13 | 66 | 0 | — |
What is it indicated for?
The ZSAlign Cervical Interbody System is a cervical interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at multiple contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment prior to treatment with…
Read the full statement (205 words)
The ZSAlign Cervical Interbody System is a cervical interbody fusion device intended for use in
skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at
multiple contiguous levels. DDD is defined as discogenic pain with degeneration of the disc
confirmed by history and radiographic studies. Patients should be skeletally mature and have had at
least six (6) weeks of non-operative treatment prior to treatment with this device.
The ZSAlign Cervical Interbody System consists of an interbody cage used in conjunction with an
anterior cervical plate, available in 2-, 3-, and 4-hole configurations, and bone screws. The interbody
cage component is not intended for cage-only use and must be implanted as part of the cage-plate-
screw construct. Plate and bone screw fixation are required for every use of this device.
The interbody cage is to be filled with autograft bone and/or allogenic bone graft composed of
cancellous, cortical, and/or corticocancellous bone, or a bone void filler cleared by FDA for use in
intervertebral body fusion, to facilitate fusion. The ZSAlign Cervical Interbody System is intended to
be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine
(C2-T1), with bone screw fixation at each treated level.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K261451 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261451: ZSAlign Cervical 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/K261451
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026