510(k) · Cleared
ClearedCalix-C Cervical Interbody Spacer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
X-Spine Systems, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Aug 1, 2017 as substantially equivalent to K112036 (X-Spine Systems, Inc., 2011) and 4 other predicates after a 112-day review. Its family tree reaches back 16 generations to 2001. 15 later devices descend from it.
- Decided
- Aug 1, 2017
- Review
- 112 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 16 generations to K003155 (2001). 196 ancestors in all, the oldest K792352 (1979). 15 later devices descend from it, 5 citing it directly.
- Root · 16 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 12 generations between
- 3 generations backK121649 Construx Mini Peek TI Spacer SystemOrthofix · 2012
- 2 generations backK142152 Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand…Orthofix, Inc. · 2015
- 1 generation backK151064 Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System…Biomet Spine · 2015
- This deviceK171075 Calix-C Cervical Interbody SpacerX-Spine Systems, Inc. · 2017
- Descendant · cites it directly · 9 of its ownK202398 Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2021
- Descendant · cites it directly · 9 of its ownK202305 Zavation IBF SystemZavation Medical Products, LLC · 2020
- Descendant · 2 generations on · 6 of its ownK221049 Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC · 2022
- Descendant · 3 generations on · 3 of its ownK231766 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2023
- Descendant · 2 generations on · 3 of its ownK212811 Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC · 2022
Show all 16 generations
- Root · 16 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 15 generations backK012254 VBROsteotech, Inc. · 2001
- 14 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 13 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 12 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 11 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 10 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 9 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 8 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 7 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 6 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 5 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 4 generations backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- 3 generations backK121649 Construx Mini Peek TI Spacer SystemOrthofix · 2012
- 2 generations backK142152 Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand…Orthofix, Inc. · 2015
- 1 generation backK151064 Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System…Biomet Spine · 2015
- This deviceK171075 Calix-C Cervical Interbody SpacerX-Spine Systems, Inc. · 2017
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2021 · cites it directly9descendants
- K202305Zavation IBF SystemZavation Medical Products, LLC · 2020 · cites it directly9descendants
- K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC · 2022 · 2 generations on6descendants
- K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2023 · 3 generations on3descendants
- K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC · 2022 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −15 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −14 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −13 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −12 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −11 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −10 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −9 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −8 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −7 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −6 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −5 | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
| −4 | K100889 | Endoskeleton TC | Titan Spine, LLC | 2010 | — |
| −3 | K121649 | Construx Mini Peek TI Spacer System | Orthofix | 2012 | — |
| −2 | K142152 | Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System | Orthofix, Inc. | 2015 | — |
| −1 | K151064 | Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System… | Biomet Spine | 2015 | — |
| 0 (this device) | K171075 | Calix-C Cervical Interbody Spacer | X-Spine Systems, Inc. | 2017 | — |
| +1 | K202398 | Ti3Z Cervical Interbody System | Zavation Medical Products, LLC | 2021 | — |
| +1 | K202305 | Zavation IBF System | Zavation Medical Products, LLC | 2020 | — |
| +2 | K221049 | Zavation VariSync Plate System and VariSync Spacer System | Zavation Medical Products, LLC | 2022 | — |
| +3 | K231766 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | 2023 | — |
| +2 | K212811 | Ti3Z Lumbar Interbody System | Zavation Medical Products, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1996 | 6 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 11 | 0 |
| 2002 | 8 | 0 |
| 2003 | 13 | 0 |
| 2004 | 24 | 0 |
| 2005 | 12 | 0 |
| 2006 | 8 | 0 |
| 2007 | 14 | 0 |
| 2008 | 22 | 0 |
| 2009 | 15 | 0 |
| 2010 | 5 | 0 |
| 2011 | 8 | 0 |
| 2012 | 8 | 0 |
| 2013 | 5 | 0 |
| 2014 | 6 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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.
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? (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 |
|---|---|---|---|
| * | K112036 | Calix PC Spinal Implant SystemSummary page 5…™ Cervical Interbody Spacer and to expand the Indications for Use. VI. PREDICATE DEVICES Primary: X‐spine, Inc.: Calix PC™ Spinal Implant System ‐‐ K112036 Additional: Globus Medical, Inc.: PATRIOT® Cervical Spacers, (including COLONIAL® and COLONIAL® TPS)… | 2011 |
| * | K143578 | SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Summary page 5…PC™ Spinal Implant System ‐‐ K112036 Additional: Globus Medical, Inc.: PATRIOT® Cervical Spacers, (including COLONIAL® and COLONIAL® TPS) ‐‐ K143578 Medtronic Sofamor Danek USA, Inc.: ANATOMIC PEEK PTC Cervical Fusion System – K160528 S… | 2016 |
| * | K160528 | ANATOMIC PEEK PTC Cervical Fusion SystemSummary page 5…including COLONIAL® and COLONIAL® TPS) ‐‐ K143578 Medtronic Sofamor Danek USA, Inc.: ANATOMIC PEEK PTC Cervical Fusion System – K160528 Stryker Spine: AERO®‐C Cervical Cage System – K152532 Biomet Spine: C‐Thru™ Anterior Spinal System –… | 2016 |
| * | K152532 | AERO -C Cervical Cage SystemSummary page 5… Medtronic Sofamor Danek USA, Inc.: ANATOMIC PEEK PTC Cervical Fusion System – K160528 Stryker Spine: AERO®‐C Cervical Cage System – K152532 Biomet Spine: C‐Thru™ Anterior Spinal System – K151064 VII. INDICATIONS FOR USE The Calix‐C™ Cervic… | 2015 |
| * | K151064 | Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Summary page 5…al Fusion System – K160528 Stryker Spine: AERO®‐C Cervical Cage System – K152532 Biomet Spine: C‐Thru™ Anterior Spinal System – K151064 VII. INDICATIONS FOR USE The Calix‐C™ Cervical Interbody Spacer is intended for spinal fusion procedures at one… | 2015 |
What descends from it? (15)
See all 155 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 16 years and passes through 10 companies; a new generation was cleared every 10 months on median.
- 22 of the 196 ancestors have a recall of any class.
- Of its descendants, K202398 (Zavation Medical Products, LLC, 2021) has gone furthest, with 9 descendants of its own.
- 11 other devices also cite its predicate K112036.
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. 2017, 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 Calix-C™ Cervical Interbody Spacer is intended for spinal fusion procedures at one level (C2 – T1 inclusive) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autograft and/or allograft comprised of cancellous and/or…
Read the full statement (125 words)
The Calix-C™ Cervical Interbody Spacer is intended for spinal fusion procedures at one level (C2 – T1 inclusive) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Patients should receive at least six (6) weeks of non-operative treatment prior to treatment with the Calix-C™ Cervical Interbody Spacer.
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine (i.e., posterior cervical screw and rod systems and anterior cervical plate systems).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171075 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171075: Calix-C Cervical Interbody Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171075
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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