510(k) · Cleared
ClearedCONDUIT™ ZERO-P™ VA Secured Spacer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avalign Technologies, Inc. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Jun 18, 2026 as substantially equivalent to K112068 (Synthes Spine Co.Lp, 2011) and 4 other predicates after a 274-day review. Its family tree reaches back 25 generations to 1984. 1 of the 510 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 18, 2026
- Review
- 274 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 25 generations to K841189 (1984). 509 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet. 1 of the 510 devices in this family, counting this one, has a Class I recall.
- Root · 25 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations between
- 3 generations backK200613 Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation · 2020
- 2 generations backK201585 Monterey AL Interbody SystemStryker Corporation · 2020 · Recalled
- 1 generation backK250072 CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc. · 2025
- This deviceK252982 CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc. · 2026
Show all 25 generations
- Root · 25 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 24 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 23 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 22 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 21 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 20 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 19 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 18 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 17 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 16 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 15 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 14 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 13 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 12 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 11 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 10 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 9 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 8 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 7 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 6 generations backK160955 Tritanium® PL CageStryker · 2016
- 5 generations backK181014 Tritanium PL CageStryker Spine · 2018
- 4 generations backK183249 Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL…Stryker Spine · 2019
- 3 generations backK200613 Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation · 2020
- 2 generations backK201585 Monterey AL Interbody SystemStryker Corporation · 2020 · Recalled
- 1 generation backK250072 CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc. · 2025
- This deviceK252982 CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc. · 2026
Class I recalls in this family
- K073202 Ardis Spacer3 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −25 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −24 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −23 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −22 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −21 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −20 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −19 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −18 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −17 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −16 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −15 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −14 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −13 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −12 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −11 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −10 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −9 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −8 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −7 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −6 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −5 | K181014 | Tritanium PL Cage | Stryker Spine | 2018 | — |
| −4 | K183249 | Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable… | Stryker Spine | 2019 | — |
| −3 | K200613 | Tritanium® X TL Expandable Curved Posterior Lumbar Cage | Stryker Corporation | 2020 | — |
| −2 | K201585 | Monterey AL Interbody System | Stryker Corporation | 2020 | 4 |
| −1 | K250072 | CONDUIT™ SYNFIX™ Evolution Secured Spacer System | Avalign Technologies, Inc. | 2025 | — |
| 0 (this device) | K252982 | CONDUIT™ ZERO-P™ VA Secured Spacer System | Avalign Technologies, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 8 | 0 |
| 2000 | 7 | 0 |
| 2001 | 12 | 0 |
| 2002 | 14 | 0 |
| 2003 | 23 | 0 |
| 2004 | 43 | 0 |
| 2005 | 31 | 0 |
| 2006 | 16 | 0 |
| 2007 | 21 | 0 |
| 2008 | 52 | 1 |
| 2009 | 42 | 0 |
| 2010 | 31 | 0 |
| 2011 | 40 | 0 |
| 2012 | 23 | 0 |
| 2013 | 28 | 0 |
| 2014 | 26 | 0 |
| 2015 | 21 | 0 |
| 2016 | 14 | 0 |
| 2017 | 9 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 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.
1 device in this family has a Class I recall. 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? (5)
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 |
|---|---|---|---|
| * | K112068 | Synthes Zero-P Variable Angle (VA)Summary page 5…n Number: 21 CFR 888.3080 Classification Panel: Orthopaedic and Rehabilitation Devices Panel (87) Primary Predicate: Synthes Zero-P Variable Angle (K112068) Additional Predicates: EIT Cellular Titanium® Cervical Cage (K170503) EIT Cellular Titanium® C… | 2011 |
| * | K170503 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Summary page 5…Rehabilitation Devices Panel (87) Primary Predicate: Synthes Zero-P Variable Angle (K112068) Additional Predicates: EIT Cellular Titanium® Cervical Cage (K170503) EIT Cellular Titanium® Cervical Cage (K201605) Globus Medical Inc. HEDRO… | 2017 |
| * | K201605 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Summary page 5…-P Variable Angle (K112068) Additional Predicates: EIT Cellular Titanium® Cervical Cage (K170503) EIT Cellular Titanium® Cervical Cage (K201605) Globus Medical Inc. HEDRON™ Cervical Spacers (K191243) CONDUITTM SYNFIXT… | 2020 |
| * | K191243 | HEDRON Cervical SpacersSummary page 5…vical Cage (K170503) EIT Cellular Titanium® Cervical Cage (K201605) Globus Medical Inc. HEDRON™ Cervical Spacers (K191243) CONDUITTM SYNFIXTM Evolution Secured Spacer System (K250072) Device Description: The CONDUI… | 2019 |
| * | K250072 | CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemSummary page 5…01605) Globus Medical Inc. HEDRON™ Cervical Spacers (K191243) CONDUITTM SYNFIXTM Evolution Secured Spacer System (K250072) Device Description: The CONDUIT ZERO-P VA Secured Spacers are intervertebral body fusion de… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 42 years and passes through 14 companies; a new generation was cleared every 10 months on median.
- 58 of the 509 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K112068.
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. 2026, 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 CONDUIT ZERO-P VA Spacer is a stand-alone anterior cervical interbody fusion device with a microscopic roughened surface and micro and nano-scale features indicated for use at one or two levels of the cervical spine (C2-T1) in skeletally mature patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous…
Read the full statement (141 words)
The CONDUIT ZERO-P VA Spacer is a stand-alone anterior cervical interbody fusion device with a microscopic roughened surface and micro and nano-scale features indicated for use at one or two levels of the cervical spine (C2-T1) in skeletally mature patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion.
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. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment.
The interior of the spacer component should be packed with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft and implanted via an anterior approach.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K252982 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252982: CONDUIT™ ZERO-P™ VA Secured Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252982
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026