510(k) · Cleared
Recalled · Class II · 2016Calix Lumbar Spinal Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
X-Spine Systems, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Oct 23, 2013 as substantially equivalent to K073291 (Medtronic Sofamor Danek USA, Inc., 2008) and 4 other predicates after a 166-day review. Its family tree reaches back 12 generations to 1984. 21 later devices descend from it. It has been recalled 4 times.
- Decided
- Oct 23, 2013
- Review
- 166 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 4
- Predicates
- 5
Its longest line of descent runs back 12 generations to K841189 (1984). 62 ancestors in all. 21 later devices descend from it, 3 citing it directly.
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations between
- 3 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 2 generations backK102293 Caliber SpacerGlobus Medical, Inc. · 2011
- 1 generation backK130478 Sustain and Sustain Radiolucent SpacersGlobus Medical, Inc. · 2013
- This deviceK131350 Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc. · 2013
- Descendant · cites it directly · 12 of its ownK160959 Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc. · 2016
- Descendant · 2 generations on · 11 of its ownK211873 PSX Interbody SystemAlphatec Spine, Inc. · 2021
- Descendant · 3 generations on · 8 of its ownK222455 Calibrate LTX Interbody SystemAlphatec Spine, Inc. · 2022
- Descendant · 3 generations on · 7 of its ownK231438 Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc. · 2023
- Descendant · 4 generations on · 7 of its ownK223611 Calibrate LTX Interbody SystemAlphatec Spine, Inc. · 2023
Show all 12 generations
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 10 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 9 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 8 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 7 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 6 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 5 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 4 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- 3 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 2 generations backK102293 Caliber SpacerGlobus Medical, Inc. · 2011
- 1 generation backK130478 Sustain and Sustain Radiolucent SpacersGlobus Medical, Inc. · 2013
- This deviceK131350 Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc. · 2013
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc. · 2016 · cites it directly12descendants
- K211873PSX Interbody SystemAlphatec Spine, Inc. · 2021 · 2 generations on11descendants
- K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc. · 2022 · 3 generations on8descendants
- K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc. · 2023 · 3 generations on7descendants
- K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc. · 2023 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −11 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −10 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −9 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −8 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −7 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −6 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −5 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| −4 | K090899 | Depuy Spine Lateral System | Depuy Spine, Inc. | 2009 | — |
| −3 | K093242 | Patriot Transcontinental Llif Spacer | Globus Medical, Inc. | 2009 | — |
| −2 | K102293 | Caliber Spacer | Globus Medical, Inc. | 2011 | — |
| −1 | K130478 | Sustain and Sustain Radiolucent Spacers | Globus Medical, Inc. | 2013 | — |
| 0 (this device) | K131350 | Calix Lumbar Spinal Implant System | X-Spine Systems, Inc. | 2013 | — |
| +1 | K160959 | Xsert Lumbar Expandable Interbody System | X-Spine Systems, Inc. | 2016 | — |
| +2 | K211873 | PSX Interbody System | Alphatec Spine, Inc. | 2021 | — |
| +3 | K222455 | Calibrate LTX Interbody System | Alphatec Spine, Inc. | 2022 | — |
| +3 | K231438 | Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System | Alphatec Spine, Inc. | 2023 | — |
| +4 | K223611 | Calibrate LTX Interbody System | Alphatec Spine, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 5 | 0 |
| 2003 | 8 | 0 |
| 2004 | 9 | 0 |
| 2005 | 3 | 0 |
| 2007 | 5 | 0 |
| 2008 | 7 | 0 |
| 2009 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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 MAX? 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 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 |
|---|---|---|---|
| * | K073291 | Capstone Spinal SystemSummary page 2…t System is substantially equivalent in indications and design principles to predicate devices. PREDICATE DEVICE(S) " Medtronic Sofamor Danek - CAPSTONE Spinal System (K073291) " Globus Medical, Inc. - Patriot Spacer System (K072970) * Globus Medical, Inc. - Sustain & Sustain Radiolucent Spacers (K1… | 2008 |
| * | K072970 | Patriot SpacersSummary page 2…ign principles to predicate devices. PREDICATE DEVICE(S) " Medtronic Sofamor Danek - CAPSTONE Spinal System (K073291) " Globus Medical, Inc. - Patriot Spacer System (K072970) * Globus Medical, Inc. - Sustain & Sustain Radiolucent Spacers (K1 30478) " K2M, Inc. - Aleutian Spinal System (K082698) *… | 2008 |
| * | K130478 | Sustain and Sustain Radiolucent Spacers Cleared while this submission was under review Summary page 2…mor Danek - CAPSTONE Spinal System (K073291) " Globus Medical, Inc. - Patriot Spacer System (K072970) * Globus Medical, Inc. - Sustain & Sustain Radiolucent Spacers (K1 30478) " K2M, Inc. - Aleutian Spinal System (K082698) * Depuy Spine, Inc. - CONCORDE System (K081917) PERFORMANCE DATA To establish… | 2013 |
| * | K082698 | Aleutian Ibf SystemSummary page 2…lobus Medical, Inc. - Patriot Spacer System (K072970) * Globus Medical, Inc. - Sustain & Sustain Radiolucent Spacers (K1 30478) " K2M, Inc. - Aleutian Spinal System (K082698) * Depuy Spine, Inc. - CONCORDE System (K081917) PERFORMANCE DATA To establish device performance, the following standardized t… | 2009 |
| * | K081917 | Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsSummary page 2…70) * Globus Medical, Inc. - Sustain & Sustain Radiolucent Spacers (K1 30478) " K2M, Inc. - Aleutian Spinal System (K082698) * Depuy Spine, Inc. - CONCORDE System (K081917) PERFORMANCE DATA To establish device performance, the following standardized tests were conducted on full device constructs:… | 2009 |
What descends from it? (21)
See all 213 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 17, 2016 | Class II | Z-0125-2017 | Component design/selection | The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in the intervertebral space. |
| May 17, 2016 | Class II | Z-0127-2017 | Component design/selection | The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in the intervertebral space. |
| May 17, 2016 | Class II | Z-0124-2017 | Component design/selection | The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in the intervertebral space. |
| May 17, 2016 | Class II | Z-0126-2017 | Component design/selection | The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in the intervertebral space. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 6 of the 62 ancestors have a recall of any class.
- Of its descendants, K160959 (X-Spine Systems, Inc., 2016) has gone furthest, with 12 descendants of its own.
- 40 other devices also cite its predicate K073291.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
The X-spine Calix Lumbar Spinal Implant System is intended for spinal fusion procedures at one or two contiguous levels (L2 - S1 inclusive) in skeletally mature patients with degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the lumbosacral spine. DDOD patients may also have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).…
Read the full statement (162 words)
The X-spine Calix Lumbar Spinal Implant System is intended for spinal fusion procedures at one or two contiguous levels (L2 - S1 inclusive) in skeletally mature patients with degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the lumbosacral spine. DDOD patients may also have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved level(s). These implants are to be packed with autogenous bone graft and implanted via an anterior, posterior, and/or transforaminal approach. Patients should receive at least six (6) months of non-operative treatment prior to treatment with a lumbosacral intervertebral fusion device.
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131350 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131350: Calix Lumbar 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/K131350
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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