510(k) · Cleared
ClearedCervical Spinal Truss System (CSTS) Interbody Fusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
4Web, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Jan 8, 2018 as substantially equivalent to K121741 (4-Web, Inc., 2012) and 3 other predicates after a 101-day review. Its family tree reaches back 22 generations to 1984. 12 later devices descend from it.
- Decided
- Jan 8, 2018
- Review
- 101 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 22 generations to K841189 (1984). 257 ancestors in all. 12 later devices descend from it, 4 citing it directly.
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations between
- 3 generations backK160955 Tritanium® PL CageStryker · 2016
- 2 generations backK162262 Tritanium® PL CageStryker · 2016
- 1 generation backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- This deviceK173159 Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc. · 2018
- Descendant · cites it directly · 10 of its ownK190870 Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc. · 2019
- Descendant · cites it directly · 3 of its ownK223362 Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion…4Web Medical, Inc. · 2023
- Descendant · cites it directly · 3 of its ownK221266 Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc. · 2023
- Descendant · 2 generations on · 2 of its ownK231739 Cervical Spine Truss System (CSTS)4Web Medical, Inc. · 2023
- Descendant · 2 generations on · 2 of its ownK193153 SPIRA-C Integrated Fixation SystemCamber Spine Technologies · 2020
Show all 22 generations
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 20 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 19 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 18 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 16 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 15 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 14 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 12 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 11 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 10 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 9 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 8 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 7 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 6 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 5 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 4 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 3 generations backK160955 Tritanium® PL CageStryker · 2016
- 2 generations backK162262 Tritanium® PL CageStryker · 2016
- 1 generation backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- This deviceK173159 Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc. · 2018
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc. · 2019 · cites it directly10descendants
- K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc. · 2023 · cites it directly3descendants
- K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc. · 2023 · cites it directly3descendants
- K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc. · 2023 · 2 generations on2descendants
- K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies · 2020 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −21 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −20 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −19 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −18 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −16 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −15 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −14 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −12 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −11 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −10 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −9 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −8 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −7 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −6 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −5 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −4 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −3 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −2 | K162262 | Tritanium® PL Cage | Stryker | 2016 | — |
| −1 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| 0 (this device) | 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 | — |
| +1 | K223362 | Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device | 4Web Medical, Inc. | 2023 | — |
| +1 | K221266 | Cervical Spine Truss System (CSTS) Interbody Fusion Device | 4Web Medical, Inc. | 2023 | — |
| +2 | K231739 | Cervical Spine Truss System (CSTS) | 4Web Medical, Inc. | 2023 | — |
| +2 | K193153 | SPIRA-C Integrated Fixation System | Camber Spine Technologies | 2020 | — |
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 | 14 | 0 |
| 2004 | 22 | 0 |
| 2005 | 16 | 0 |
| 2006 | 7 | 0 |
| 2007 | 12 | 0 |
| 2008 | 36 | 0 |
| 2009 | 25 | 0 |
| 2010 | 15 | 0 |
| 2011 | 21 | 0 |
| 2012 | 10 | 0 |
| 2013 | 11 | 0 |
| 2014 | 12 | 0 |
| 2015 | 8 | 0 |
| 2016 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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.
Planning a device in ODP? 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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K121741 | 4-Web Cervical STS (Spinal Truss System)Summary page 5…Page 2 of 2 Predicate Device(s): The primary predicate device is the 4WEB CSTS (K121741). Additional predicates include K142112, K171496 and K111119. Performance Standards: Performance testing has been completed per… | 2012 |
| * | K142112 | 4WEB Spinal Implant ProductsSummary page 5…Page 2 of 2 Predicate Device(s): The primary predicate device is the 4WEB CSTS (K121741). Additional predicates include K142112, K171496 and K111119. Performance Standards: Performance testing has been completed per the following standards: ASTMF2077 - St… | 2014 |
| * | K171496 | Tritanium C Anterior Cervical CageSummary page 5…Page 2 of 2 Predicate Device(s): The primary predicate device is the 4WEB CSTS (K121741). Additional predicates include K142112, K171496 and K111119. Performance Standards: Performance testing has been completed per the following standards: ASTMF2077 - Static and… | 2017 |
| * | K111119 | Trabecular Metal (TM) Fusion DeviceSummary page 5…Page 2 of 2 Predicate Device(s): The primary predicate device is the 4WEB CSTS (K121741). Additional predicates include K142112, K171496 and K111119. Performance Standards: Performance testing has been completed per the following standards: ASTMF2077 - Static and dynamic axia… | 2011 |
What descends from it? (12)
See all 124 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190870 | Cervical Spinal Truss System-Stand Alone (CSTS-SA) | 2019 | 10 |
| K223362 | Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device | 2023 | 3 |
| K221266 | Cervical Spine Truss System (CSTS) Interbody Fusion Device | 2023 | 3 |
| K212527 | Cervical Spine Truss System Plating Solution (CSTS-PS) | 2022 | 0 |
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 34 years and passes through 14 companies; a new generation was cleared every 9 months on median.
- 30 of the 257 ancestors have a recall of any class.
- Of its descendants, K190870 (4Web, Inc., 2019) has gone furthest, with 10 descendants of its own.
- 3 other devices also cite its predicate K121741.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
The Cervical Spine Truss System (CSTS) 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. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. CSTS Interbody Fusion Devices are used as an adjunct to fusion in the cervical spine and are placed via an anterior…
Read the full statement (118 words)
The Cervical Spine Truss System (CSTS) 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. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. CSTS 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. The device must be used with supplement fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173159 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173159: Cervical Spinal Truss System (CSTS) Interbody Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173159
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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