510(k) · Cleared
ClearedSPIRA-C Integrated Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Camber Spine Technologies · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Apr 24, 2020 as substantially equivalent to K102606 (Stryker Spine, 2011) and 6 other predicates after a 163-day review. Its family tree reaches back 24 generations to 1984. 2 later devices descend from it.
- Decided
- Apr 24, 2020
- Review
- 163 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 24 generations to K841189 (1984). 310 ancestors in all, the oldest K792352 (1979). 2 later devices descend from it, 2 citing it directly.
- Root · 24 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 20 generations between
- 3 generations backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- 2 generations backK173159 Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc. · 2018
- 1 generation backK190870 Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc. · 2019
- This deviceK193153 SPIRA-C Integrated Fixation SystemCamber Spine Technologies · 2020
- Descendant · cites it directly · 0 of its ownK253894 BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o. · 2026
- Descendant · cites it directly · 0 of its ownK223837 SPIRA®-C Integrated Fixation SystemCamber Spine Technologies · 2023
Show all 24 generations
- Root · 24 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 23 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 22 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 21 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 20 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 19 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 18 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 17 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 16 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 15 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 14 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 13 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 12 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 11 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 10 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 9 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 8 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 7 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 6 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 5 generations backK160955 Tritanium® PL CageStryker · 2016
- 4 generations backK162262 Tritanium® PL CageStryker · 2016
- 3 generations backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- 2 generations backK173159 Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc. · 2018
- 1 generation backK190870 Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc. · 2019
- This deviceK193153 SPIRA-C Integrated Fixation SystemCamber Spine Technologies · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −24 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −23 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −22 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −21 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −20 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −19 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −18 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −17 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −16 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −15 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −14 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −13 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −12 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −11 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −10 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −9 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −8 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −7 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −6 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −5 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −4 | K162262 | Tritanium® PL Cage | Stryker | 2016 | — |
| −3 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| −2 | K173159 | Cervical Spinal Truss System (CSTS) Interbody Fusion Device | 4Web, Inc. | 2018 | — |
| −1 | K190870 | Cervical Spinal Truss System-Stand Alone (CSTS-SA) | 4Web, Inc. | 2019 | — |
| 0 (this device) | K193153 | SPIRA-C Integrated Fixation System | Camber Spine Technologies | 2020 | — |
| +1 | K253894 | BMD Titanium Spinal Fusion System | Global Biomedica s.r.o. | 2026 | — |
| +1 | K223837 | SPIRA®-C Integrated Fixation System | Camber Spine Technologies | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1996 | 6 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 12 | 0 |
| 2002 | 10 | 0 |
| 2003 | 15 | 0 |
| 2004 | 26 | 0 |
| 2005 | 17 | 0 |
| 2006 | 11 | 0 |
| 2007 | 15 | 0 |
| 2008 | 40 | 0 |
| 2009 | 27 | 0 |
| 2010 | 18 | 0 |
| 2011 | 24 | 0 |
| 2012 | 14 | 0 |
| 2013 | 14 | 0 |
| 2014 | 14 | 0 |
| 2015 | 8 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 OVE? 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 OVE device
- #1 K241846 E3D™-C Interbody Systemscore 32.1 · 32 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K102606 | Avs Anchor-C Cervical Cage SystemSummary page 4…3080, Intervertebral body fusion device Class: II Product Code: OVE Primary Predicate: Stryker Spine Anchor C (K102606) Additional Predicate(s): Centinel Spine STALIF C (K120819, K072415), Spinal Elements Mosaic-C… | 2011 |
| * | K120819 | Stalif CSummary page 4…II Product Code: OVE Primary Predicate: Stryker Spine Anchor C (K102606) Additional Predicate(s): Centinel Spine STALIF C (K120819, K072415), Spinal Elements Mosaic-C (K133218, K071833), and 4WEB Cervical Spinal Truss System-Sta… | 2012 |
| * | K072415 | Stalif (TM) CSummary page 4…Product Code: OVE Primary Predicate: Stryker Spine Anchor C (K102606) Additional Predicate(s): Centinel Spine STALIF C (K120819, K072415), Spinal Elements Mosaic-C (K133218, K071833), and 4WEB Cervical Spinal Truss System-Stand Alone… | 2008 |
| * | K133218 | Crystal ®; Mosaic ®; Vertu ®Summary page 4…Stryker Spine Anchor C (K102606) Additional Predicate(s): Centinel Spine STALIF C (K120819, K072415), Spinal Elements Mosaic-C (K133218, K071833), and 4WEB Cervical Spinal Truss System-Stand Alone (K190870) Reference Devices:… | 2014 |
| * | K071833 | Mosaic DevicesSummary page 4…Spine Anchor C (K102606) Additional Predicate(s): Centinel Spine STALIF C (K120819, K072415), Spinal Elements Mosaic-C (K133218, K071833), and 4WEB Cervical Spinal Truss System-Stand Alone (K190870) Reference Devices: Ca… | 2007 |
| * | K190870 | Cervical Spinal Truss System-Stand Alone (CSTS-SA)Summary page 4…K072415), Spinal Elements Mosaic-C (K133218, K071833), and 4WEB Cervical Spinal Truss System-Stand Alone (K190870) Reference Devices: Camber Spine Technologies SPIRA-C Open Matrix Cervical Interbody… | 2019 |
| * | K172446 | SPIRA-C Open Matrix Cervical InterbodySummary page 4…(K190870) Reference Devices: Camber Spine Technologies SPIRA-C Open Matrix Cervical Interbody (K172446), Camber Spine Technologies Coveris Cervical Cage (K170050), Fortico Anterior Cervical Fixation S… | 2017 |
| † | K170050 | Z-CAD smile | 2018 |
| † | K191584 | FORTICO Anterior Cervical Fixation System | 2019 |
| † | K180980 | ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System | 2018 |
What descends from it? (2)
2 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 36 years and passes through 15 companies; a new generation was cleared every 9 months on median.
- 36 of the 310 ancestors have a recall of any class.
- Of its descendants, K253894 (Global Biomedica s.r.o., 2026) has gone furthest, with 0 descendants of its own.
- 16 other devices also cite its predicate K102606.
How does its category compare?
All OVE devicesOVE Intervertebral Fusion Device With Integrated Fixation, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · OVE
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVE
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVE
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVE
132in 2025
MAUDE reports naming product code OVE, 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 | 1 | — | 0 | 0 |
| 2008 | 4 | 131 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 210 | 0 | 2 |
| 2011 | 8 | 139 | 0 | 19 |
| 2012 | 7 | 125 | 0 | 59 |
| 2013 | 5 | 71 | 1 | 250 |
| 2014 | 11 | 168 | 1 | 150 |
| 2015 | 12 | 113 | 1 | 173 |
| 2016 | 15 | 149 | 1 | 145 |
| 2017 | 9 | 100 | 1 | 134 |
| 2018 | 7 | 105 | 0 | 210 |
| 2019 | 7 | 87 | 0 | 169 |
| 2020 | 13 | 149 | 0 | 162 |
| 2021 | 10 | 93 | 2 | 186 |
| 2022 | 10 | 144 | 0 | 200 |
| 2023 | 16 | 97 | 0 | 148 |
| 2024 | 6 | 56 | 0 | 142 |
| 2025 | 10 | 105 | 0 | 132 |
| 2026 | 13 | 66 | 0 | — |
What is it indicated for?
The Camber Spine Technologies SPIRA-C Integrated Fixation System consists of a stand-alone interbody device indicated for use at one or two contiguous levels in the cervical spine, from C2-C3 disc to the C7-T1 disc, in skeletally mature patients who have had six weeks of non-operative treatment for the cervical disk disease. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on…
Read the full statement (131 words)
The Camber Spine Technologies SPIRA-C Integrated Fixation System consists of a stand-alone interbody device indicated for use at one or two contiguous levels in the cervical spine, from C2-C3 disc to the C7-T1 disc, in skeletally mature patients who have had six weeks of non-operative treatment for the cervical disk disease. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The SPIRA-C Integrated Fixation System must be used with internal screw fixation. The Camber Spine Technologies SPIRA-C Integrated Fixation System must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193153: SPIRA-C Integrated Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193153
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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