510(k) · Cleared
ClearedCervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
4Web Medical, Inc. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Feb 2, 2023 as substantially equivalent to K190870 (4Web, Inc., 2019) and 2 other predicates after a 91-day review. Its family tree reaches back 24 generations to 1984. 3 later devices descend from it.
- Decided
- Feb 2, 2023
- Review
- 91 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 24 generations to K841189 (1984). 428 ancestors in all, the oldest K792352 (1979). 3 later devices descend from it, 2 citing it directly.
- Root · 24 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 20 generations between
- 3 generations backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- 2 generations backK173159 Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc. · 2018
- 1 generation backK190870 Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc. · 2019
- This deviceK223362 Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion…4Web Medical, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK233966 Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK253200 Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK243934 Stable-L Lumbar Interbody SystemNexus Spine, LLC · 2025
Show all 24 generations
- Root · 24 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 23 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 22 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 21 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 20 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 19 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 18 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 17 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 16 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 15 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 14 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 13 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 12 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 11 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 10 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 9 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 8 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 7 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 6 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 5 generations backK160955 Tritanium® PL CageStryker · 2016
- 4 generations backK162262 Tritanium® PL CageStryker · 2016
- 3 generations backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- 2 generations backK173159 Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc. · 2018
- 1 generation backK190870 Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc. · 2019
- This deviceK223362 Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion…4Web Medical, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See all- K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc. · 2024 · cites it directly1descendant
- K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc. · 2025 · cites it directly0descendants
- K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −24 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −23 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −22 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −21 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −20 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −19 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −18 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −17 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −16 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −15 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −14 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −13 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −12 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −11 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −10 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −9 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −8 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −7 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −6 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −5 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −4 | K162262 | Tritanium® PL Cage | Stryker | 2016 | — |
| −3 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| −2 | K173159 | Cervical Spinal Truss System (CSTS) Interbody Fusion Device | 4Web, Inc. | 2018 | — |
| −1 | K190870 | Cervical Spinal Truss System-Stand Alone (CSTS-SA) | 4Web, Inc. | 2019 | — |
| 0 (this device) | K223362 | Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device | 4Web Medical, Inc. | 2023 | — |
| +1 | K233966 | Anterior Spine Truss System-Stand Alone (ASTS-SA) | 4Web Medical, Inc. | 2024 | — |
| +1 | K253200 | Cervical Spine Truss System - Stand Alone (CSTS-SA) | 4Web Medical, Inc. | 2025 | — |
| +2 | K243934 | Stable-L Lumbar Interbody System | Nexus Spine, LLC | 2025 | — |
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 | 4 | 0 |
| 1993 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 7 | 0 |
| 1997 | 9 | 0 |
| 1998 | 6 | 0 |
| 1999 | 7 | 0 |
| 2000 | 13 | 0 |
| 2001 | 17 | 0 |
| 2002 | 17 | 0 |
| 2003 | 20 | 0 |
| 2004 | 36 | 0 |
| 2005 | 23 | 0 |
| 2006 | 19 | 0 |
| 2007 | 25 | 0 |
| 2008 | 48 | 0 |
| 2009 | 32 | 0 |
| 2010 | 24 | 0 |
| 2011 | 25 | 0 |
| 2012 | 16 | 0 |
| 2013 | 16 | 0 |
| 2014 | 13 | 0 |
| 2015 | 9 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 2 | 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 OVE? 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 |
|---|---|---|---|
| * | K190870 | Cervical Spinal Truss System-Stand Alone (CSTS-SA)Summary page 5…lant into adjacent vertebral bodies for bony fixation. Predicate Device(s): The primary predicate device is the 4WEB Medical Cervical Spine Truss System – Stand Alone (K190870). Additional predicates for this submission is the 4WEB Medical Cervical Spine Truss System (K173159) and the 4WEB Medical Latera… | 2019 |
| * | K173159 | Cervical Spinal Truss System (CSTS) Interbody Fusion DeviceSummary page 5…evice is the 4WEB Medical Cervical Spine Truss System – Stand Alone (K190870). Additional predicates for this submission is the 4WEB Medical Cervical Spine Truss System (K173159) and the 4WEB Medical Lateral Spine Truss System – Plating Solution (K203065). Performance Standards: Performance testing has b… | 2018 |
| * | K203065 | Lumbar Spine Truss System Plating Solution (LSTS-PS)Summary page 5…. Additional predicates for this submission is the 4WEB Medical Cervical Spine Truss System (K173159) and the 4WEB Medical Lateral Spine Truss System – Plating Solution (K203065). Performance Standards: Performance testing has been completed on the CSTS-SA implants per the following standards: • AS… | 2021 |
What descends from it? (3)
2 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 39 years and passes through 15 companies; a new generation was cleared every 10 months on median.
- 48 of the 428 ancestors have a recall of any class.
- Of its descendants, K233966 (4Web Medical, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K190870.
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. 2023, 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 Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level or two contiguous disc levels and is to be used with two titanium alloy screws or fixation anchors which accompany the device. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies.…
Read the full statement (146 words)
The Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level or two contiguous disc levels and is to be used with two titanium alloy screws or fixation anchors which accompany the device. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. CSTS-SA Interbody Fusion Devices are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. When using the CTST-SA interbody with fixation anchors, the device must be used with supplemental fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223362 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223362: Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223362
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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