510(k) · Cleared
ClearedCalix PC Spinal Implant System
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 Nov 8, 2011 as substantially equivalent to P980048 (Sulzer Spine-Tech, 2001) and 2 other predicates after a 113-day review. Its family tree reaches back 1 generation to 2001. 1 of the 779 devices in its family, counting itself, has a Class I recall. 775 later devices descend from it.
- Decided
- Nov 8, 2011
- Review
- 113 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to P980048 (2001). 3 ancestors in all. 775 later devices descend from it, 12 citing it directly. 1 of the 779 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backP980048 Bak/Cervical (Bak/C) Interbody Fusion SystemSulzer Spine-Tech · 2001
- This deviceK112036 Calix PC Spinal Implant SystemX-Spine Systems, Inc. · 2011
- Descendant · cites it directly · 694 of its ownK110632 Lucent or Lucent MagnumSpinal Elements, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 615 of its ownK122967 LucentSpinal Elements, Inc. · 2013
- Descendant · 2 generations on · 590 of its ownK140319 Coroent TI-C SystemNuvasive, Inc. · 2014
- Descendant · 3 generations on · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- Descendant · 4 generations on · 479 of its ownK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
Showing 5 of 775 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 775 · See all- K110632Lucent or Lucent MagnumSpinal Elements, Inc. · 2012 · cites it directly694descendants
- K122967LucentSpinal Elements, Inc. · 2013 · 2 generations on615descendants
- K140319Coroent TI-C SystemNuvasive, Inc. · 2014 · 2 generations on590descendants
- K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · 3 generations on588descendants
- K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015 · 4 generations on479descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P980048 | Bak/Cervical (Bak/C) Interbody Fusion System | Sulzer Spine-Tech | 2001 | — |
| 0 (this device) | K112036 | Calix PC Spinal Implant System | X-Spine Systems, Inc. | 2011 | — |
| +1 | K110632 | Lucent or Lucent Magnum | Spinal Elements, Inc. | 2012 | 1 |
| +2 | K122967 | Lucent | Spinal Elements, Inc. | 2013 | — |
| +2 | K140319 | Coroent TI-C System | Nuvasive, Inc. | 2014 | — |
| +3 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| +4 | K151472 | NuVasive CoRoent Lumbar System | Nu Vasive, Incorporated | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 12 | 0 |
| 2015 | 22 | 0 |
| 2016 | 34 | 0 |
| 2017 | 58 | 0 |
| 2018 | 49 | 0 |
| 2019 | 60 | 0 |
| 2020 | 82 | 0 |
| 2021 | 63 | 1 |
| 2022 | 71 | 0 |
| 2023 | 86 | 0 |
| 2024 | 89 | 0 |
| 2025 | 80 | 0 |
| 2026 | 65 | 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 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? (3)
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 |
|---|---|---|---|
| * | P980048 | Bak/Cervical (Bak/C) Interbody Fusion SystemSummary page 1…ablishment Registration number is 3005031160. The owner/operator number for X-spine Systems, Inc. is 9063903. PREDICATE DEVICES e BAK/Cervical Interbody Fusion System (P980048/53) o Spinal Elements Crystal (K073351) ¢ (Calix Spinal Implant System K083637) INTENDED USE When used as a vertebral body repl… | 2001 |
| * | K073351 | CrystalSummary page 1…31160. The owner/operator number for X-spine Systems, Inc. is 9063903. PREDICATE DEVICES e BAK/Cervical Interbody Fusion System (P980048/53) o Spinal Elements Crystal (K073351) ¢ (Calix Spinal Implant System K083637) INTENDED USE When used as a vertebral body replacement, the X-spine Calix PC System is… | 2008 |
| * | K083637 | Calix Spinal Implant SystemSummary page 1…pine Systems, Inc. is 9063903. PREDICATE DEVICES e BAK/Cervical Interbody Fusion System (P980048/53) o Spinal Elements Crystal (K073351) ¢ (Calix Spinal Implant System K083637) INTENDED USE When used as a vertebral body replacement, the X-spine Calix PC System is intended for use in the thoracic and/or… | 2009 |
What descends from it? (775)
See all 77512 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110632 | Lucent or Lucent Magnum | 2012 | 694 |
| K133653 | Anatomic Peek PTC Cervical Fusion System | 2014 | 286 |
| K130573 | Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, Dlif | 2013 | 251 |
| K133218 | Crystal ®; Mosaic ®; Vertu ® | 2014 | 130 |
| K133192 | Mectalif Tipeek | 2014 | 16 |
| K171075 | Calix-C Cervical Interbody Spacer | 2017 | 15 |
| K131951 | Irix-C Cervical Integrated Fusion System | 2013 | 12 |
| K161809 | ShurFit CpTi-HA ACIF Interbody Fusion System | 2016 | 5 |
| K132596 | Proposed Optimus | 2014 | 5 |
| K161649 | Virtu C Spinal Implant System | 2016 | 2 |
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.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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. 2011, 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?
When used as a vertebral body replacement, the X-spine Calix PC System is intended for use in the thoracic and/or thoracolumbar spine {T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). The Calix device, when used as a vertebral body replacement, can be packed with either allograft or autograft. When used as an intervertebral…
Read the full statement (195 words)
When used as a vertebral body replacement, the X-spine Calix PC System is intended for use in the thoracic and/or thoracolumbar spine {T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). The Calix device, when used as a vertebral body replacement, can be packed with either allograft or autograft.
When used as an intervertebral body fusion device, the X-spine Calix PC System is intended for spinal fusion procedures at one level (C3-C7) 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 autogenous bone. Patients should receive 6 weeks non-operative treatment prior to treatment with the Calix intervertebral body fusion device.
For all indications, this device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical, thoracic or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).
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/K112036 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112036: Calix PC Spinal Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112036
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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