510(k) · Cleared
ClearedSTCC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Spine, LLC · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Mar 14, 2011 as substantially equivalent to K091088 (Ldr Spine USA, 2009) and 2 other predicates after a 368-day review. Its family tree reaches back 10 generations to 1984. 346 later devices descend from it.
- Decided
- Mar 14, 2011
- Review
- 368 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K841189 (1984). 34 ancestors in all. 346 later devices descend from it, 1 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 deviceK100698 STCCCardinal Spine, LLC · 2011
- Descendant · cites it directly · 345 of its ownK111439 Chesapeake (Cervical Components)K2m, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 330 of its ownK133494 Chesapeake Spinal SystemK2m, Inc. · 2014
- Descendant · 3 generations on · 315 of its ownK160125 Cascadia Interbody SystemK2m · 2016
- Descendant · 4 generations on · 169 of its ownK162264 Cascadia Interbody SystemK2m, Inc. · 2016
- Descendant · 4 generations on · 145 of its ownK171140 Matrixx SystemNexxt Spine, LLC · 2017
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 deviceK100698 STCCCardinal Spine, LLC · 2011
Showing 5 of 346 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 346 · See all- K111439Chesapeake (Cervical Components)K2m, Inc. · 2011 · cites it directly345descendants
- K133494Chesapeake Spinal SystemK2m, Inc. · 2014 · 2 generations on330descendants
- K160125Cascadia Interbody SystemK2m · 2016 · 3 generations on315descendants
- K162264Cascadia Interbody SystemK2m, Inc. · 2016 · 4 generations on169descendants
- K171140Matrixx SystemNexxt Spine, LLC · 2017 · 4 generations on145descendants
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) | K100698 | STCC | Cardinal Spine, LLC | 2011 | — |
| +1 | K111439 | Chesapeake (Cervical Components) | K2m, Inc. | 2011 | 1 |
| +2 | K133494 | Chesapeake Spinal System | K2m, Inc. | 2014 | — |
| +3 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| +4 | K162264 | Cascadia Interbody System | K2m, Inc. | 2016 | — |
| +4 | K171140 | Matrixx System | Nexxt Spine, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 6 | 0 |
| 2016 | 4 | 0 |
| 2017 | 11 | 0 |
| 2018 | 13 | 0 |
| 2019 | 19 | 0 |
| 2020 | 34 | 0 |
| 2021 | 31 | 0 |
| 2022 | 41 | 0 |
| 2023 | 49 | 0 |
| 2024 | 43 | 0 |
| 2025 | 47 | 0 |
| 2026 | 45 | 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? (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 |
|---|---|---|---|
| * | K091088 | LDR Spine Cervical Interbody Fusion SystemSummary page 2…substantially equivalent in indications, design principles, materials and performance to the following predicate devices: the LDR Spine Cervical Interbody Fusion System (K091088) from LDR Spine USA, the Synthes Zero-P (K07298 1) from Synthes Spine, and the Novel® Spinal Spacer System (K08 1730) from Alphat… | 2009 |
| * | K072981 | Synthes Zero-PSummary page 2…rinciples, materials and performance to the following predicate devices: the LDR Spine Cervical Interbody Fusion System (K091088) from LDR Spine USA, the Synthes Zero-P (K07298 1) from Synthes Spine, and the Novel® Spinal Spacer System (K08 1730) from Alphatec Spine, Inc.… | 2008 |
| * | K081730 | Novel Cervical Spinal Spacer SystemSummary page 2…ices: the LDR Spine Cervical Interbody Fusion System (K091088) from LDR Spine USA, the Synthes Zero-P (K07298 1) from Synthes Spine, and the Novel® Spinal Spacer System (K08 1730) from Alphatec Spine, Inc.… | 2008 |
What descends from it? (346)
See all 3461 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111439 | Chesapeake (Cervical Components) | 2011 | 345 |
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 27 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 5 of the 34 ancestors have a recall of any class.
- Of its descendants, K111439 (K2m, Inc., 2011) has gone furthest, with 345 descendants of its own.
- 50 other devices also cite its predicate K091088.
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. 2011, 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 STCC is intended to be used as an adjunct to spinal fusion procedures at one level (C2-T1) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be implanted via an anterior approach and used with autogenous bone graft and supplemental fixation, such as an anterior plating system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100698 · printed Nov 4, 2026
Cite this page
510(k) Report. “K100698: STCC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100698
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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