510(k) · Cleared
ClearedSPIRA-C Open Matrix Cervical Interbody
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Camber Spine Technologies · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Nov 7, 2017 as substantially equivalent to K133529 (Camber Spine, 2014) and 2 other predicates after an 85-day review. Its family tree reaches back 15 generations to 2001. 6 later devices descend from it.
- Decided
- Nov 7, 2017
- Review
- 85 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K003155 (2001). 83 ancestors in all, the oldest K841189 (1984). 6 later devices descend from it, 4 citing it directly.
- Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 11 generations between
- 3 generations backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- 2 generations backK121741 4-Web Cervical STS (Spinal Truss System)4-Web, Inc. · 2012
- 1 generation backK142112 4WEB Spinal Implant Products4Web, Inc. · 2014
- This deviceK172446 SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies · 2017
- Descendant · cites it directly · 2 of its ownK193153 SPIRA-C Integrated Fixation SystemCamber Spine Technologies · 2020
- Descendant · cites it directly · 1 of its ownK222806 Kodiak C Spinal Implant SystemMet One Technologies, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK253894 BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o. · 2026
- Descendant · cites it directly · 0 of its ownK250335 IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting · 2025
- Descendant · 2 generations on · 0 of its ownK230851 Kodiak Lumbar Spacer SystemMet One Technologies, LLC · 2023
Show all 15 generations
- Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 14 generations backK012254 VBROsteotech, Inc. · 2001
- 13 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 12 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 11 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 10 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 9 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 8 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 7 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 6 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 5 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 4 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 3 generations backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- 2 generations backK121741 4-Web Cervical STS (Spinal Truss System)4-Web, Inc. · 2012
- 1 generation backK142112 4WEB Spinal Implant Products4Web, Inc. · 2014
- This deviceK172446 SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies · 2020 · cites it directly2descendants
- K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC · 2022 · cites it directly1descendant
- K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o. · 2026 · 2 generations on0descendants
- K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting · 2025 · cites it directly0descendants
- K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −14 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −13 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −12 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −11 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −10 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −9 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −8 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −7 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −6 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −5 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −4 | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
| −3 | K100889 | Endoskeleton TC | Titan Spine, LLC | 2010 | — |
| −2 | K121741 | 4-Web Cervical STS (Spinal Truss System) | 4-Web, Inc. | 2012 | — |
| −1 | K142112 | 4WEB Spinal Implant Products | 4Web, Inc. | 2014 | — |
| 0 (this device) | K172446 | SPIRA-C Open Matrix Cervical Interbody | Camber Spine Technologies | 2017 | — |
| +1 | K193153 | SPIRA-C Integrated Fixation System | Camber Spine Technologies | 2020 | — |
| +1 | K222806 | Kodiak C Spinal Implant System | Met One Technologies, LLC | 2022 | — |
| +2 | K253894 | BMD Titanium Spinal Fusion System | Global Biomedica s.r.o. | 2026 | — |
| +1 | K250335 | IVA & AEON Cervical and Lumbar Cage System | K&J Consulting | 2025 | — |
| +2 | K230851 | Kodiak Lumbar Spacer System | Met One Technologies, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 4 | 0 |
| 2003 | 8 | 0 |
| 2004 | 11 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
| 2007 | 7 | 0 |
| 2008 | 10 | 0 |
| 2009 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 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 |
|---|---|---|---|
| * | K133529 | Camber Spine Coveris Cervical CageSummary page 4…1 CFR §888.3080, Intervertebral body fusion device Class: II Product Codes: ODP Primary Predicate: Camber Spine Coveris (K133529) Additional Predicate(s): 4WEB Medical CERVICAL CAGE Spinal Truss System (K142112, K121741) Re… | 2014 |
| * | K142112 | 4WEB Spinal Implant ProductsSummary page 4…P Primary Predicate: Camber Spine Coveris (K133529) Additional Predicate(s): 4WEB Medical CERVICAL CAGE Spinal Truss System (K142112, K121741) Reference Device: Camber Spine Technologies SPIRA Open Matrix ALIF (K162986) Indications For Use: The Camb… | 2014 |
| * | K121741 | 4-Web Cervical STS (Spinal Truss System)Summary page 4…y Predicate: Camber Spine Coveris (K133529) Additional Predicate(s): 4WEB Medical CERVICAL CAGE Spinal Truss System (K142112, K121741) Reference Device: Camber Spine Technologies SPIRA Open Matrix ALIF (K162986) Indications For Use: The Camber Spine… | 2012 |
| † | K162986 | SPIRA Open Matrix ALIF | 2017 |
What descends from it? (6)
4 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 16 years and passes through 9 companies; a new generation was cleared every 10 months on median.
- 7 of the 83 ancestors have a recall of any class.
- Of its descendants, K193153 (Camber Spine Technologies, 2020) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K133529.
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. 2017, 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 Camber Spine Technologies SPIRA-C Open Matrix Cervical Interbody is indicated for use at one or two contiguous levels in the cervical spine, from C3-C7, in skeletally mature patients who have had six weeks of non-operative treatment for the degenerative disk disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. The Camber…
Read the full statement (118 words)
The Camber Spine Technologies SPIRA-C Open Matrix Cervical Interbody is indicated for use at one or two contiguous levels in the cervical spine, from C3-C7, in skeletally mature patients who have had six weeks of non-operative treatment for the degenerative disk disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. The Camber Spine Technologies SPIRA-C Open Matrix Cervical Interbody is intended to be used with additional FDA-cleared supplementary fixation systems.
The Camber Spine Technologies SPIRA-C Open Matrix Cervical Interbody system must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172446 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172446: SPIRA-C Open Matrix Cervical Interbody.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172446
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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