510(k) · Cleared
ClearedInfix Anterior Lumbar System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Spine, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Dec 20, 2013 as substantially equivalent to K031672 (Spinal Concepts, Inc., 2003) and 1 other predicate after a 105-day review. Its family tree reaches back 3 generations to 2001. 1 of the 35 devices in its family, counting itself, has a Class I recall. 28 later devices descend from it.
- Decided
- Dec 20, 2013
- Review
- 105 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K010530 (2001). 6 ancestors in all, the oldest P950002 (1996). 28 later devices descend from it, 5 citing it directly. 1 of the 35 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 2 generations backK020048 Modification to Geo StructureInterpore Cross Intl. · 2002
- 1 generation backK031672 Spinal Concepts, Inc. Infix SystemSpinal Concepts, Inc. · 2003
- This deviceK132790 Infix Anterior Lumbar SystemZimmer Spine, Inc. · 2013
- Descendant · cites it directly · 19 of its ownK143297 Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior…Zimmer Spine, Inc. · 2015
- Descendant · cites it directly · 11 of its ownK162986 SPIRA Open Matrix ALIFCamber Spine Technologies · 2017
- Descendant · 2 generations on · 10 of its ownK180724 SPIRA Open Matrix LLIFCamber Spine Technologies, LLC · 2018
- Descendant · 2 generations on · 9 of its ownK190483 SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies · 2019
- Descendant · cites it directly · 5 of its ownK231199 Solar Lumbar Interbody Fusion SystemDegen Medical · 2023
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacerdirect predicate · 2008
Most influential descendants
Showing 5 of 28 · See all- K143297Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…Zimmer Spine, Inc. · 2015 · cites it directly19descendants
- K162986SPIRA Open Matrix ALIFCamber Spine Technologies · 2017 · cites it directly11descendants
- K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC · 2018 · 2 generations on10descendants
- K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies · 2019 · 2 generations on9descendants
- K231199Solar Lumbar Interbody Fusion SystemDegen Medical · 2023 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −2 | K020048 | Modification to Geo Structure | Interpore Cross Intl. | 2002 | — |
| −1 | K031672 | Spinal Concepts, Inc. Infix System | Spinal Concepts, Inc. | 2003 | — |
| 0 (this device) | K132790 | Infix Anterior Lumbar System | Zimmer Spine, Inc. | 2013 | — |
| +1 | K143297 | Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical… | Zimmer Spine, Inc. | 2015 | — |
| +1 | K162986 | SPIRA Open Matrix ALIF | Camber Spine Technologies | 2017 | — |
| +2 | K180724 | SPIRA Open Matrix LLIF | Camber Spine Technologies, LLC | 2018 | — |
| +2 | K190483 | SPIRA Open Matrix ALIF and LLIF | Camber Spine Technologies | 2019 | — |
| +1 | K231199 | Solar Lumbar Interbody Fusion System | Degen Medical | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 5 | 0 |
| 2025 | 6 | 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.
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 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? (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 |
|---|---|---|---|
| * | K031672 | Spinal Concepts, Inc. Infix SystemSummary page 2…Names Number _ _______ lnFix)' Anterior Lumbar Device (System) Original/Applicant Spinal Concepts K031672 August 07, 2003 Product Code: MOP Ardis Spacer Original Applicant Abbott Spine… | 2003 |
| * | K073202 | Ardis SpacerSummary page 2…inal Concepts K031672 August 07, 2003 Product Code: MOP Ardis Spacer Original Applicant Abbott Spine K073202 January 30, 2008 Product Code: MAX General Device Description: The InFix System is comprised of impla… | 2008 |
What descends from it? (28)
See all 285 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143297 | Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody… | 2015 | 19 |
| K162986 | SPIRA Open Matrix ALIF | 2017 | 11 |
| K231199 | Solar Lumbar Interbody Fusion System | 2023 | 5 |
| K200958 | MODULIF-A Anterior Lumbar Interbody Fusion System | 2020 | 0 |
| K180695 | FBC 921 (Alif) | 2018 | 0 |
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.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · Direct predicate · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 6 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K143297 (Zimmer Spine, Inc., 2015) has gone furthest, with 19 descendants of its own.
- 5 other devices also cite its predicate K031672.
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?
When used as a vertebral body replacement device, the InFix® System is intended for use in the thoracic and/or lumbar spine (T3-L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e.. partial verlebrectomy procedures) due to tumor or trauma (i.e., fracture). The InFix is designed to restore the biomnechanical integrity of the anterior and middle spinal column even in the absence of fusion for a prolonged period. the…
Read the full statement (217 words)
When used as a vertebral body replacement device, the InFix® System is intended for use in the thoracic and/or lumbar spine (T3-L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e.. partial verlebrectomy procedures) due to tumor or trauma (i.e., fracture). The InFix is designed to restore the biomnechanical integrity of the anterior and middle spinal column even in the absence of fusion for a prolonged period. the InFix implant is intended to be used with bone graft.
When used as an intervertebral body fusion device the InFix System is indicated for use with autogenous bone graft at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (ODD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DOD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non-operative treatment. When used as an intervertebral body fusion device, the InFix implant is intended to be used with supplemental fixation.
For both of the indications listed above, the InFix implant is intended to be implanted via an open anterior approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132790 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132790: Infix Anterior Lumbar System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132790
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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