510(k) · Cleared
ClearedC-Thru Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ebi, L.P. · MQP Spinal Vertebral Body Replacement Device
Cleared on Oct 15, 2009 as substantially equivalent to K040928 (Interpore Cross Intl., 2004) and 3 other predicates after a 72-day review. Its family tree reaches back 7 generations to 2001. 1 of the 508 devices in its family, counting itself, has a Class I recall. 492 later devices descend from it.
- Decided
- Oct 15, 2009
- Review
- 72 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K010530 (2001). 15 ancestors in all, the oldest P950002 (1996). 492 later devices descend from it, 7 citing it directly. 1 of the 508 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 6 generations backK062083 Synfix -LRSynthes Spine Co.Lp · 2007
- 5 generations backK072253 Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · Recalled
- 4 generations backK073470 Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine · 2008
- 3 generations backK080758 Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp. · 2008
- 2 generations backK081636 Peek-Optima Alif SpacerBiomet Spine · 2008
- 1 generation backK082406 Expandable Peek-Optima ImplantEbi, L.P. · 2009
- This deviceK092336 C-Thru Spinal SystemEbi, L.P. · 2009
- Descendant · cites it directly · 389 of its ownK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- Descendant · 2 generations on · 331 of its ownK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
- Descendant · 2 generations on · 324 of its ownK112444 Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc. · 2011
- Descendant · 2 generations on · 281 of its ownK122037 Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion…Medtronic Sofamor Danek, Inc. · 2013
- Descendant · 3 generations on · 228 of its ownK150135 DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015
Showing 5 of 492 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 492 · See all- K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010 · cites it directly389descendants
- K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011 · 2 generations on331descendants
- K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc. · 2011 · 2 generations on324descendants
- K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc. · 2013 · 2 generations on281descendants
- K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015 · 3 generations on228descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −6 | K062083 | Synfix -LR | Synthes Spine Co.Lp | 2007 | — |
| −5 | K072253 | Synfix-LR Spacer | Synthes Spine Co.Lp | 2007 | 1 |
| −4 | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXX | Stryker Spine | 2008 | — |
| −3 | K080758 | Avs PL Peek Spacers, Models 48351 and 48353 | Stryker Corp. | 2008 | — |
| −2 | K081636 | Peek-Optima Alif Spacer | Biomet Spine | 2008 | — |
| −1 | K082406 | Expandable Peek-Optima Implant | Ebi, L.P. | 2009 | — |
| 0 (this device) | K092336 | C-Thru Spinal System | Ebi, L.P. | 2009 | — |
| +1 | K100214 | Cornerstone PSR Cervical Interbody Fusion Device | Medtronic Sofamor Danek | 2010 | — |
| +2 | K111264 | Cornerstone (R) PSR Cervical Fusion System | Medtronic Sofamor Danek USA | 2011 | — |
| +2 | K112444 | Anatomic Peek Cervical Fusion System | Medtronic Sofamor Danck USA, Inc. | 2011 | — |
| +2 | K122037 | Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System… | Medtronic Sofamor Danek, Inc. | 2013 | — |
| +3 | K150135 | DIVERGENCE-L Anterior/Oblique Lumbar Fusion System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 6 | 0 |
| 2014 | 10 | 0 |
| 2015 | 8 | 0 |
| 2016 | 13 | 0 |
| 2017 | 27 | 0 |
| 2018 | 19 | 0 |
| 2019 | 33 | 0 |
| 2020 | 31 | 0 |
| 2021 | 50 | 1 |
| 2022 | 47 | 0 |
| 2023 | 54 | 0 |
| 2024 | 62 | 0 |
| 2025 | 63 | 0 |
| 2026 | 60 | 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 MQP device
- #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 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 |
|---|---|---|---|
| * | K040928 | Expandable Peek VBR ImplantSummary page 1…ues of safety or effectiveness. An example of a predicate intervertebral body fusion device distributed for the similar indications includes the Expandable PEEK Implant (K040928 and K082406), and Novel® Spinal Spacer System (K081730), while the Small Stature Spacer System (K063393) has similar design featu… | 2004 |
| * | K082406 | Expandable Peek-Optima ImplantSummary page 1…y or effectiveness. An example of a predicate intervertebral body fusion device distributed for the similar indications includes the Expandable PEEK Implant (K040928 and K082406), and Novel® Spinal Spacer System (K081730), while the Small Stature Spacer System (K063393) has similar design features. Based u… | 2009 |
| * | K081730 | Novel Cervical Spinal Spacer SystemSummary page 1…te intervertebral body fusion device distributed for the similar indications includes the Expandable PEEK Implant (K040928 and K082406), and Novel® Spinal Spacer System (K081730), while the Small Stature Spacer System (K063393) has similar design features. Based upon the mechanical testing, C-ThruTM Anteri… | 2008 |
| * | K063393 | Small Stature SpacersSummary page 1…for the similar indications includes the Expandable PEEK Implant (K040928 and K082406), and Novel® Spinal Spacer System (K081730), while the Small Stature Spacer System (K063393) has similar design features. Based upon the mechanical testing, C-ThruTM Anterior Spinal System is substantially equivalent for… | 2007 |
What descends from it? (492)
See all 4927 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100214 | Cornerstone PSR Cervical Interbody Fusion Device | 2010 | 389 |
| K113796 | Solitaire-C Cervical Spacer System | 2012 | 142 |
| K111983 | Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-Xxxxxx | 2011 | 31 |
| K151064 | Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small… | 2015 | 17 |
| K132926 | Velofixtm Interbody Fusion System | 2014 | 10 |
| K121320 | C7 Anterior Cervical Intervertebral Fusion Cage | 2012 | 2 |
| K132483 | Innesis Peek Cervical Cage | 2014 | 0 |
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.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 8 years and passes through 6 companies; a new generation was cleared every 5 months on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K100214 (Medtronic Sofamor Danek, 2010) has gone furthest, with 389 descendants of its own.
- 9 other devices also cite its predicate K040928.
How does its category compare?
All MQP devicesMQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MQP
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQP
187in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQP
168in 2025
MAUDE reports naming product code MQP, 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 | 30 | 107 | 2 | 61 |
| 2008 | 17 | 47 | 0 | 76 |
| 2009 | 11 | 115 | 14 | 111 |
| 2010 | 6 | 174 | 2 | 166 |
| 2011 | 8 | 237 | 1 | 121 |
| 2012 | 7 | 82 | 2 | 141 |
| 2013 | 3 | 90 | 0 | 207 |
| 2014 | 5 | 125 | 0 | 216 |
| 2015 | 8 | 126 | 0 | 258 |
| 2016 | 0 | — | 0 | 129 |
| 2017 | 9 | 97 | 0 | 141 |
| 2018 | 6 | 152 | 0 | 130 |
| 2019 | 8 | 93 | 0 | 117 |
| 2020 | 3 | 103 | 15 | 157 |
| 2021 | 0 | — | 0 | 208 |
| 2022 | 1 | — | 1 | 137 |
| 2023 | 1 | — | 0 | 71 |
| 2024 | 4 | 187 | 0 | 98 |
| 2025 | 0 | — | 0 | 168 |
| 2026 | 3 | 102 | 0 | — |
What is it indicated for?
The C-ThruTM Anterior Spinal System is indicated for vertebral body replacement and intervertebral fusion. When used as a vertebral body replacement device, the C-ThruTM Spacers are indicated for use in the thoracolumbar spine (i.e., Ti to 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…
Read the full statement (212 words)
The C-ThruTM Anterior Spinal System is indicated for vertebral body replacement and intervertebral fusion. When used as a vertebral body replacement device, the C-ThruTM Spacers are indicated for use in the thoracolumbar spine (i.e., Ti to 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 C-ThruTM Spacers are also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The C-ThruTM Spacers are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
When used as a cervical intervertebral fusion device, the C-Thru Anterior Spinal System is intended for spinal fusion procedures at one level (C2 to Ti) in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. The C-Thru Spacers are intended for use with supplemental fixation and autogenous bone graft to facilitate the fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092336 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092336: C-Thru Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092336
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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