510(k) · Cleared
ClearedSTGC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Spine, LLC · MQP Spinal Vertebral Body Replacement Device
Cleared on Aug 17, 2012 as substantially equivalent to K003043 (Depuyacromed, 2001) and 2 other predicates after a 121-day review. Its family tree reaches back 10 generations to 1984. 59 later devices descend from it.
- Decided
- Aug 17, 2012
- Review
- 121 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K841189 (1984). 28 ancestors in all. 59 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 6 generations between
- 3 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 2 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 1 generation backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- This deviceK121176 STGCCardinal Spine, LLC · 2012
- Descendant · cites it directly · 58 of its ownK142030 STGC-LordoticCardinal Spine, LLC · 2015
- Descendant · cites it directly · 57 of its ownK152568 C-VBRCardinal Spine, LLC · 2016
- Descendant · 2 generations on · 55 of its ownK162315 FORTIFY Corpectomy SpacersGlobus Medical, Inc. · 2017
- Descendant · 3 generations on · 28 of its ownK181328 T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc. · 2018
- Descendant · 4 generations on · 27 of its ownK183510 T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc. · 2019
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 backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 4 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 3 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 2 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 1 generation backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- This deviceK121176 STGCCardinal Spine, LLC · 2012
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K142030STGC-LordoticCardinal Spine, LLC · 2015 · cites it directly58descendants
- K152568C-VBRCardinal Spine, LLC · 2016 · cites it directly57descendants
- K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc. · 2017 · 2 generations on55descendants
- K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc. · 2018 · 3 generations on28descendants
- K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc. · 2019 · 4 generations on27descendants
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 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −4 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −3 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −2 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| −1 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| 0 (this device) | K121176 | STGC | Cardinal Spine, LLC | 2012 | — |
| +1 | K142030 | STGC-Lordotic | Cardinal Spine, LLC | 2015 | — |
| +1 | K152568 | C-VBR | Cardinal Spine, LLC | 2016 | — |
| +2 | K162315 | FORTIFY Corpectomy Spacers | Globus Medical, Inc. | 2017 | — |
| +3 | K181328 | T2 STRATOSPHERE™ Expandable Corpectomy System | Medtronic Sofamor Danek USA, Inc. | 2018 | — |
| +4 | K183510 | T2 STRATOSPHERE Expandable Corpectomy System | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 5 | 0 |
| 2019 | 7 | 0 |
| 2020 | 5 | 0 |
| 2022 | 3 | 0 |
| 2023 | 8 | 0 |
| 2024 | 9 | 0 |
| 2025 | 7 | 0 |
| 2026 | 12 | 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 MQP? 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? (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 |
|---|---|---|---|
| * | K003043 | Surgical Titanium Mesh SystemSummary page 2…s substantially equivalent in indications and design principles to the following legally marketed predicate devices: DePuy AcroMed, Surgical Titanium MeshTM System, K003043; Synthes (USA), Synthes SynMeshT Im Spacer, K003275; and LDR Spine USA, LDR Spine Cervical Interbody Fusion System, K09… | 2001 |
| * | K003275 | Synthes Synmesh Spacer SystemSummary page 2…ciples to the following legally marketed predicate devices: DePuy AcroMed, Surgical Titanium MeshTM System, K003043; Synthes (USA), Synthes SynMeshT Im Spacer, K003275; and LDR Spine USA, LDR Spine Cervical Interbody Fusion System, K091088. The subject and predicate devices all are intended… | 2001 |
| * | K091088 | LDR Spine Cervical Interbody Fusion SystemSummary page 2…d, Surgical Titanium MeshTM System, K003043; Synthes (USA), Synthes SynMeshT Im Spacer, K003275; and LDR Spine USA, LDR Spine Cervical Interbody Fusion System, K091088. The subject and predicate devices all are intended to be used to provide support after resection or removal of a damaged, colla… | 2009 |
What descends from it? (59)
See all 592 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 28 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 28 ancestors have a recall of any class.
- Of its descendants, K142030 (Cardinal Spine, LLC, 2015) has gone furthest, with 58 descendants of its own.
- 25 other devices also cite its predicate K003043.
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. 2012, 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 STGC is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). The STGC is intended to be used with autograft or allograft in combination with supplemental fixation indicated for use in the thoracolumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121176 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121176: STGC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121176
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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