510(k) · Cleared
ClearedCAVUX CervicalCage-L SA System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Providence Medical Technology, Inc. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Mar 10, 2017 as substantially equivalent to K150053 (Centinel Spine, Inc., 2015) and 7 other predicates after an 88-day review. Its family tree reaches back 12 generations to 1984.
- Decided
- Mar 10, 2017
- Review
- 88 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 12 generations to K841189 (1984). 75 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations between
- 3 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 2 generations backK102606 Avs Anchor-C Cervical Cage SystemStryker Spine · 2011 · Recalled
- 1 generation backK120819 Stalif CCentinel Spine, Inc. · 2012
- This deviceK163474 CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc. · 2017
Show all 12 generations
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 10 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 9 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 6 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 5 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 4 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 3 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 2 generations backK102606 Avs Anchor-C Cervical Cage SystemStryker Spine · 2011 · Recalled
- 1 generation backK120819 Stalif CCentinel Spine, Inc. · 2012
- This deviceK163474 CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −11 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −10 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −9 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −6 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −5 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −4 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| −3 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| −2 | K102606 | Avs Anchor-C Cervical Cage System | Stryker Spine | 2011 | 1 |
| −1 | K120819 | Stalif C | Centinel Spine, Inc. | 2012 | — |
| 0 (this device) | K163474 | CAVUX CervicalCage-L SA System | Providence Medical Technology, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 6 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 8 | 0 |
| 2009 | 6 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 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? (8)
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 |
|---|---|---|---|
| * | K150053 | STALIF C; STALIF C-TiSummary page 5…Predicate 510k Number Manufacturer or Model Name Type K150053 K142079, STALIF C® Centinel Spine Primary K120819… | 2015 |
| * | K142079 | Stalif Cti, Stalif CSummary page 5…Predicate 510k Number Manufacturer or Model Name Type K150053 K142079, STALIF C® Centinel Spine Primary K120819… | 2014 |
| * | K120819 | Stalif CSummary page 5…or Model Name Type K150053 K142079, STALIF C® Centinel Spine Primary K120819 AVS® Anchor-C K102606 Stryker Spine Additional… | 2012 |
| * | K102606 | Avs Anchor-C Cervical Cage SystemSummary page 5…K150053 K142079, STALIF C® Centinel Spine Primary K120819 AVS® Anchor-C K102606 Stryker Spine Additional Cervical Cage System… | 2011 |
| * | K152515 | TOMCAT Cervical Spinal SystemSummary page 5…Stryker Spine Additional Cervical Cage System TOMCAT™ Cervical K152515 Choice Spine Additional Spinal System K150765, K121… | 2015 |
| * | K150765 | LDR Spine ROI-C Cervical Cage SystemSummary page 5…TOMCAT™ Cervical K152515 Choice Spine Additional Spinal System K150765, K121103, ROI-C LDR Additional K113559, K113559 PERFORMANCE DATA… | 2015 |
| * | K121103 | LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal…Summary page 5…TOMCAT™ Cervical K152515 Choice Spine Additional Spinal System K150765, K121103, ROI-C LDR Additional K113559, K113559 PERFORMANCE DATA The CAVU… | 2012 |
| * | K113559 | LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsSummary page 5…Additional Spinal System K150765, K121103, ROI-C LDR Additional K113559, K113559 PERFORMANCE DATA The CAVUX™ Cervical Cage-L SA System has been tested in the following test modes: • ASTM F2077-1… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 33 years and passes through 9 companies; a new generation was cleared every 1.7 years on median.
- 11 of the 75 ancestors have a recall of any class.
- 8 other devices also cite its predicate K150053.
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. 2017, 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?
CAVUX™ Cervical Cage-L SA System is indicated for standalone use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. CAVUX™…
Read the full statement (113 words)
CAVUX™ Cervical Cage-L SA System is indicated for standalone use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device.
CAVUX™ Cervical Cage-L is to be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.
CAVUX™ Cervical Cage-L must be used with ALLY™ Bone Screw-L while serving as a standalone system, and as such requires no additional supplementary fixation systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163474 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163474: CAVUX CervicalCage-L SA System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163474
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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