510(k) · Cleared
Recalled · Class II · 2018Calix 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 Sep 29, 2017 as substantially equivalent to K131350 (X-Spine Systems, Inc., 2013) and 2 other predicates after a 259-day review. Its family tree reaches back 19 generations to 1984. 1 later device descends from it. It has been recalled once.
- Decided
- Sep 29, 2017
- Review
- 259 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 19 generations to K841189 (1984). 199 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations between
- 3 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 2 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 1 generation backK160916 CoRoent® Ti-C SystemNu Vasive, Incorporated · 2016
- This deviceK170119 Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK203520 Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC · 2021
Show all 19 generations
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 17 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 16 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 13 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 12 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 9 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 8 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 7 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 6 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 5 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 4 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 3 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 2 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 1 generation backK160916 CoRoent® Ti-C SystemNu Vasive, Incorporated · 2016
- This deviceK170119 Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −18 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −17 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −16 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −13 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −12 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −9 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −8 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −7 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −6 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −5 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −4 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −3 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −2 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −1 | K160916 | CoRoent® Ti-C System | Nu Vasive, Incorporated | 2016 | — |
| 0 (this device) | K170119 | Calix Lumbar Spinal Implant System | X-Spine Systems, Inc. | 2017 | — |
| +1 | K203520 | Blustone Synergy Interbody Fusion System | Blustone Synergy, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 10 | 0 |
| 2002 | 9 | 0 |
| 2003 | 13 | 0 |
| 2004 | 17 | 0 |
| 2005 | 13 | 0 |
| 2006 | 6 | 0 |
| 2007 | 13 | 0 |
| 2008 | 30 | 0 |
| 2009 | 18 | 0 |
| 2010 | 13 | 0 |
| 2011 | 11 | 0 |
| 2012 | 5 | 0 |
| 2013 | 10 | 0 |
| 2014 | 5 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (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 |
|---|---|---|---|
| * | K131350 | Calix Lumbar Spinal Implant SystemSummary page 5…K170119 - Page 2 of 5 IV. PREDICATE DEVICES Primary: X‐spine, Inc.: Calix® Lumbar Spinal Implant System (K131350) Additional: o Biomet: Zyston Straight Interbody Spacer System (K112014) o NuVasi… | 2013 |
| * | K112014 | Zyston Straight Spacer SystemSummary page 5… Primary: X‐spine, Inc.: Calix® Lumbar Spinal Implant System (K131350) Additional: o Biomet: Zyston Straight Interbody Spacer System (K112014) o NuVasive: CoRoent Ti‐C System (K160916) V. REFERENCE DEVICES NuVasive Lumbar Interbody… | 2011 |
| * | K160916 | CoRoent® Ti-C SystemSummary page 5…System (K131350) Additional: o Biomet: Zyston Straight Interbody Spacer System (K112014) o NuVasive: CoRoent Ti‐C System (K160916) V. REFERENCE DEVICES NuVasive Lumbar Interbody Implants (K161230) Alphatec Spine: Battalion… | 2016 |
| † | K161230 | NuVasive Lumbar Interbody Implants | 2016 |
| † | K160958 | Battalion Universal Spacer System | 2016 |
| † | K160597 | INDEPENDENCE MIS Spacers | 2016 |
| † | K153782 | NuVasive® Lumbar Interbody Implants | 2016 |
| † | K112036 | Calix PC Spinal Implant System | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203520 | Blustone Synergy Interbody Fusion System | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 19, 2018 | Class II | Z-0790-2019 | Labeling Change Control | This recall has been initiated due to a change in packaging and sterilization method to address potential risks of compromised sterilization presented by the existing configuration. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 33 years and passes through 13 companies; a new generation was cleared every 11 months on median.
- 24 of the 199 ancestors have a recall of any class.
- Of its descendants, K203520 (Blustone Synergy, LLC, 2021) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K131350.
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. 2017, 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 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. DDD patients may also have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These…
Read the full statement (168 words)
The 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. DDD 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 autograft and/or allograft comprised of cancellous and/or corticocancellous 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/K170119 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170119: 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/K170119
Report an extraction error
Are you the manufacturer?
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