510(k) · Cleared
ClearedAxis Chena Cervical PEEK Spacer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axis Orthopaedics · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Nov 16, 2018 as substantially equivalent to K120275 (Synthes (Usa), LLC, 2012) after a 200-day review. Its family tree reaches back 14 generations to 2001. 2 later devices descend from it.
- Decided
- Nov 16, 2018
- Review
- 200 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K003155 (2001). 69 ancestors in all, the oldest K792352 (1979). 2 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 10 generations between
- 3 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 2 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 1 generation backK120275 Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC · 2012
- This deviceK181140 Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics · 2018
- Descendant · cites it directly · 0 of its ownK213115 CHENA-C Spacer SystemKahtnu Surgical, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK192208 CORNICE Cervical Spacer SystemLegend Spine Technologies · 2019
Show all 14 generations
- Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 13 generations backK012254 VBROsteotech, Inc. · 2001
- 12 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 11 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 10 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 9 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 8 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 7 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 6 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 5 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 4 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 3 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 2 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- 1 generation backK120275 Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC · 2012
- This deviceK181140 Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics · 2018
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 |
|---|---|---|---|---|---|
| −14 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −13 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −12 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −11 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −10 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −9 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −8 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −7 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −6 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −5 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −4 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −3 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −2 | K100214 | Cornerstone PSR Cervical Interbody Fusion Device | Medtronic Sofamor Danek | 2010 | — |
| −1 | K120275 | Synthes Acis/Vertebral Spacer CR | Synthes (Usa), LLC | 2012 | — |
| 0 (this device) | K181140 | Axis Chena Cervical PEEK Spacer System | Axis Orthopaedics | 2018 | — |
| +1 | K213115 | CHENA-C Spacer System | Kahtnu Surgical, Inc. | 2021 | — |
| +1 | K192208 | CORNICE Cervical Spacer System | Legend Spine Technologies | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2004 | 10 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 7 | 0 |
| 2009 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 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? (1)
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 |
|---|---|---|---|
| * | K120275 | Synthes Acis/Vertebral Spacer CRSummary page 5…evice was performed per the applicable standards referenced above. Legally Marketed Predicate Devices: Primary: DePuy Synthes ACIS – Anterior Cervical Interbody System (K120275) Reference: K2M Cascadia – Cervical Interbody (K162264) Predicate Indications for Use: Primary: DePuy Synthes (K120275)- The Syn… | 2012 |
| † | K162264 | Cascadia Interbody System | 2016 |
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 17 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 6 of the 69 ancestors have a recall of any class.
- Of its descendants, K213115 (Kahtnu Surgical, Inc., 2021) has gone furthest, with 0 descendants of its own.
- 11 other devices also cite its predicate K120275.
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. 2018, 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 Chena Cervical Peek Spacer System is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level or two contiguous levels from C2-TI. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Chena Cervical…
Read the full statement (108 words)
The Chena Cervical Peek Spacer System is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level or two contiguous levels from C2-TI. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Chena Cervical Peek Spacer interior should be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via an anterior approach. The Chena Cervical Peek Spacer is intended to be used with supplemental fixation.
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/K181140 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181140: Axis Chena Cervical PEEK 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/K181140
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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