510(k) · Cleared
ClearedSpinal Concepts Inc. Coda
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Concepts, Inc. · MQP Spinal Vertebral Body Replacement Device
Cleared on May 27, 2004 as substantially equivalent to K022793 (Signus Medical, LLC, 2003) and 1 other predicate after a 188-day review. Its family tree reaches back 5 generations to 1984. 1 later device descends from it.
- Decided
- May 27, 2004
- Review
- 188 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K841189 (1984). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 4 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 3 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 2 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 1 generation backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- This deviceK033663 Spinal Concepts Inc. CodaSpinal Concepts, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK050997 Expanse Vertebral Body Replacement DeviceFlexuspine, Inc. · 2005
Most influential descendants
Showing 1 of 1 · See all- K050997Expanse Vertebral Body Replacement DeviceFlexuspine, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −4 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −3 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −2 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −1 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| 0 (this device) | K033663 | Spinal Concepts Inc. Coda | Spinal Concepts, Inc. | 2004 | — |
| +1 | K050997 | Expanse Vertebral Body Replacement Device | Flexuspine, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 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? (2)
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 |
|---|---|---|---|
| * | K022793 | Tetris Spinal ImplantSummary page 1…MQP Predicate Devices: Coda® is substantially equivalent to the SIGNUS TETRISTM Spinal Implant, which was cleared for use as a vertebral body replacement device via K022793 (titanium version) and K031757 (PEEK version). Device Description: Coda is manufactured from implantable grade titanium 6AL-4V a… | 2003 |
| * | K031757 | Peek Tetris Spinal ImplantSummary page 1…a® is substantially equivalent to the SIGNUS TETRISTM Spinal Implant, which was cleared for use as a vertebral body replacement device via K022793 (titanium version) and K031757 (PEEK version). Device Description: Coda is manufactured from implantable grade titanium 6AL-4V alloy that conforms to ASTM F-13… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050997 | Expanse Vertebral Body Replacement Device | 2005 | 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 20 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K050997 (Flexuspine, Inc., 2005) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K022793.
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.
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?
Coda is a vertebral body replacement device intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).
Coda is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
Coda is intended to be used with bone graft and supplemental fixation. Additionally, Coda is intended to be implanted in a paired configuration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033663 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033663: Spinal Concepts Inc. Coda.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033663
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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