510(k) · Cleared
ClearedCHENA-C Spacer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kahtnu Surgical, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Dec 6, 2021 as substantially equivalent to K181140 (Axis Orthopaedics, 2018) and 1 other predicate after a 70-day review. Its family tree reaches back 15 generations to 2001.
- Decided
- Dec 6, 2021
- Review
- 70 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K003155 (2001). 142 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet.
- Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 11 generations between
- 3 generations backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- 2 generations backK161127 The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. · 2016
- 1 generation backK173128 Alamo® CAlliance Partners, LLC · 2018
- This deviceK213115 CHENA-C Spacer SystemKahtnu Surgical, Inc. · 2021
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 backK161127 The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. · 2016
- 1 generation backK173128 Alamo® CAlliance Partners, LLC · 2018
- This deviceK213115 CHENA-C Spacer SystemKahtnu Surgical, Inc. · 2021
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 | K161127 | The Small PLATEAU (PLATEAU-C) Spacer System | Life Spine, Inc. | 2016 | — |
| −1 | K173128 | Alamo® C | Alliance Partners, LLC | 2018 | — |
| 0 (this device) | K213115 | CHENA-C Spacer System | Kahtnu Surgical, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 7 | 0 |
| 2000 | 2 | 0 |
| 2001 | 8 | 0 |
| 2002 | 7 | 0 |
| 2003 | 11 | 0 |
| 2004 | 22 | 0 |
| 2005 | 9 | 0 |
| 2006 | 5 | 0 |
| 2007 | 9 | 0 |
| 2008 | 15 | 0 |
| 2009 | 7 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 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? (2)
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 |
|---|---|---|---|
| * | K181140 | Axis Chena Cervical PEEK Spacer SystemSummary page 4…f a variety of footprints and heights of cervical interbody spacer implants to assist in interbody fusion. The previously cleared Axis Chena Cervical PEEK Spacer System (K181140) implant components are fabricated from medical implant grade Polyetheretherketone and tantalum per ASTM F2026-17 and ASTM F560-1… | 2018 |
| * | K173128 | Alamo® CSummary page 5…Primary Predicate: Axis Orthopedics – Chena Cervical PEEK Spacer System (K181140; S.E. 11/16/2018) Secondary Predicate: Alliance Spine, Alamo® C – K173128 (S.E. 3/22/2018) Reference Devices: Axis 5.5 Lumbar Pedicle Screw System (Now Axis Talkeetna) – K180301 (S.E. 4/10… | 2018 |
| † | K180301 | AXIS 5.5 Lumbar Pedicle Screw System | 2018 |
| † | K120275 | Synthes Acis/Vertebral Spacer CR | 2012 |
| † | K133784 | Vista-S Device, Associated Instrumentation | 2014 |
| † | K142251 | AVS AS PEEK Spacer | 2014 |
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 20 years and passes through 9 companies; a new generation was cleared every 10 months on median.
- 11 of the 142 ancestors have a recall of any class.
- 1 other device also cites its predicate K181140.
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. 2021, 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-C 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-C 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-C 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/K213115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213115: CHENA-C 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/K213115
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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