510(k) · Cleared
ClearedSTGC-Lordotic
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 Jan 23, 2015 as substantially equivalent to K121176 (Cardinal Spine, LLC, 2012) and 2 other predicates after a 182-day review. Its family tree reaches back 11 generations to 1984. 58 later devices descend from it.
- Decided
- Jan 23, 2015
- Review
- 182 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K841189 (1984). 38 ancestors in all. 58 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 2 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 1 generation backK121176 STGCCardinal Spine, LLC · 2012
- This deviceK142030 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
- Descendant · 5 generations on · 21 of its ownK191066 CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2019
Show all 11 generations
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 8 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 5 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 4 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 3 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 2 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 1 generation backK121176 STGCCardinal Spine, LLC · 2012
- This deviceK142030 STGC-LordoticCardinal Spine, LLC · 2015
Showing 5 of 58 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 58 · See all- 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
- K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2019 · 5 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −10 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −9 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −8 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −5 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −4 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −3 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| −2 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| −1 | K121176 | STGC | Cardinal Spine, LLC | 2012 | — |
| 0 (this device) | 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 | — |
| +5 | K191066 | CD Horizon™ Astute™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 5 | 0 |
| 2003 | 5 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K121176 | STGCSummary page 5…n (subsidence). Static expulsion testing also was performed. The performance data included in this submission demonstrate substantial equivalence to the predicate device K121176 and K003043. Clinical data were not submitted in this premarket notification. EQUIVALENCE TO MARKETED DEVICE Cardinal Spine, L… | 2012 |
| * | K131724 | Pioneer Maxfuse Vertebral Body Replacement DeviceSummary page 5…d design principles to the following legally marketed predicate devices: STGC, Cardinal Spine LLC, K121176, MaxFuse VBR System, Pioneer Surgical Technology, Inc., K131724, and Surgical Titanium Mesh System, DePuy AcroMed, K003043. The primary predicate device is K121176.… | 2013 |
| * | K003043 | Surgical Titanium Mesh SystemSummary page 5…e). Static expulsion testing also was performed. The performance data included in this submission demonstrate substantial equivalence to the predicate device K121176 and K003043. Clinical data were not submitted in this premarket notification. EQUIVALENCE TO MARKETED DEVICE Cardinal Spine, LLC has submi… | 2001 |
What descends from it? (58)
See all 581 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152568 | C-VBR | 2016 | 57 |
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 31 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 38 ancestors have a recall of any class.
- Of its descendants, K152568 (Cardinal Spine, LLC, 2016) has gone furthest, with 57 descendants of its own.
- 1 other device also cites its predicate K121176.
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. 2015, 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?
STGC-Lordotic 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). STGC-Lordotic 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/K142030 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142030: STGC-Lordotic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142030
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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