510(k) · Cleared
ClearedArdis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE)
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 Feb 12, 2015 as substantially equivalent to K132790 (Zimmer Spine, Inc., 2013) and 10 other predicates after an 87-day review. Its family tree reaches back 10 generations to 2001. 1 of the 72 devices in its family, counting itself, has a Class I recall. 19 later devices descend from it.
- Decided
- Feb 12, 2015
- Review
- 87 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 11
Its longest line of descent runs back 10 generations to K010530 (2001). 52 ancestors in all, the oldest P950002 (1996). 19 later devices descend from it, 3 citing it directly. 1 of the 72 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 6 generations between
- 3 generations backK092336 C-Thru Spinal SystemEbi, L.P. · 2009
- 2 generations backK111983 Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-XxxxxxZimmer Trabecular Metal Technology · 2011
- 1 generation backK133784 Vista-S Device, Associated InstrumentationZimmer Trabecular Metal Technology · 2014
- This deviceK143297 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 ownK172424 Velofix™ SA Cervical CageU&I Corporation · 2017 · Recalled
- Descendant · 3 generations on · 3 of its ownK210595 SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar…Camber Spine Technologies, LLC · 2021
Show all 10 generations
- Root · 10 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 9 generations backK062083 Synfix -LRSynthes Spine Co.Lp · 2007
- 8 generations backK072253 Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · Recalled
- 7 generations backK073470 Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine · 2008
- 6 generations backK080758 Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp. · 2008
- 5 generations backK081636 Peek-Optima Alif SpacerBiomet Spine · 2008
- 4 generations backK082406 Expandable Peek-Optima ImplantEbi, L.P. · 2009
- 3 generations backK092336 C-Thru Spinal SystemEbi, L.P. · 2009
- 2 generations backK111983 Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-XxxxxxZimmer Trabecular Metal Technology · 2011
- 1 generation backK133784 Vista-S Device, Associated InstrumentationZimmer Trabecular Metal Technology · 2014
- This deviceK143297 Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior…Zimmer Spine, Inc. · 2015
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer2 generations back · 2008
Most influential descendants
Showing 5 of 19 · See all- 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
- K172424Velofix™ SA Cervical CageU&I Corporation · 2017 · cites it directly5descendants
- K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC · 2021 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −9 | K062083 | Synfix -LR | Synthes Spine Co.Lp | 2007 | — |
| −8 | K072253 | Synfix-LR Spacer | Synthes Spine Co.Lp | 2007 | 1 |
| −7 | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXX | Stryker Spine | 2008 | — |
| −6 | K080758 | Avs PL Peek Spacers, Models 48351 and 48353 | Stryker Corp. | 2008 | — |
| −5 | K081636 | Peek-Optima Alif Spacer | Biomet Spine | 2008 | — |
| −4 | K082406 | Expandable Peek-Optima Implant | Ebi, L.P. | 2009 | — |
| −3 | K092336 | C-Thru Spinal System | Ebi, L.P. | 2009 | — |
| −2 | K111983 | Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-Xxxxxx | Zimmer Trabecular Metal Technology | 2011 | — |
| −1 | K133784 | Vista-S Device, Associated Instrumentation | Zimmer Trabecular Metal Technology | 2014 | — |
| 0 (this device) | 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 | K172424 | Velofix™ SA Cervical Cage | U&I Corporation | 2017 | 1 |
| +3 | K210595 | SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers | Camber Spine Technologies, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 7 | 0 |
| 2003 | 5 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 6 | 0 |
| 2008 | 4 | 1 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 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? (11)
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 |
|---|---|---|---|
| * | K132790 | Infix Anterior Lumbar SystemSummary page 9…MAX InFix Anterior Lumbar 21 CFR § 888.3080 K132790 Class II System MQP… | 2013 |
| * | K133184 | Ardis Interbody SystemSummary page 9…PMA Numbers MAX Ardis Interbody K133184 Class II 21 CFR § 888.3080… | 2014 |
| * | P950002 | Bak Interbody Fusion SystemSummary page 9…21 CFR § 888.3080 Class II MAX BAK Interbody P950002 Re-classified 2007 21 CFR § 888.3080… | 1996 |
| * | P980048 | Bak/Cervical (Bak/C) Interbody Fusion SystemSummary page 9…classified 2007 21 CFR § 888.3080 Class II MAX BAK / C Interbody P980048 Re-classified 2007 21 CFR § 888.3080… | 2001 |
| * | K031672 | Spinal Concepts, Inc. Infix SystemSummary page 9…classified 2007 21 CFR § 888.3080 MQP InFix K031672 Class II 21 CFR § 888.3060… | 2003 |
| * | K033517 | Spinal Concepts Inc. Cadence and TraxisSummary page 9…21 CFR § 888.3060 MQP TraXis Ti K033517 Class II 21 CFR § 888.3060… | 2004 |
| * | K070754 | Trabecular Metal Vertebral Body Replacement (VBR), Model# 06-115, 06-155Summary page 9…21 CFR § 888.3060 Zimmer TMT MQP K070754 Class II VBR-L 21 CFR § 888.3060 Zim… | 2007 |
| * | K113561 | TM Ardis Interbody System TM Ardis Interbody System InstrumenationSummary page 9…21 CFR § 888.3060 Zimmer TMT MAX K113561 Class II TM Ardis 21 CFR § 888.3080 Zim… | 2012 |
| * | K133784 | Vista-S Device, Associated InstrumentationSummary page 9…21 CFR § 888.3080 Zimmer TMT ODP K133784, K111983 Class II Vista-S 21 CFR § 888.3060… | 2014 |
| * | K111983 | Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-XxxxxxSummary page 9…21 CFR § 888.3080 Zimmer TMT ODP K133784, K111983 Class II Vista-S 21 CFR § 888.3060… | 2011 |
| * | K120203 | TM-400 DeviceSummary page 9…MAX Zimmer TMT 21 CFR § 888.3080 K120203 Class II TM-400* MQP… | 2012 |
What descends from it? (19)
See all 193 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 2 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 8 companies; a new generation was cleared every 7 months on median.
- 5 of the 52 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K162986 (Camber Spine Technologies, 2017) has gone furthest, with 11 descendants of its own.
- 4 other devices also cite its predicate K132790.
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. 2015, 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.c., partial vertebrectomy procedures) due to tumor or trauma (i.e., fracture). The InFix System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged…
Read the full statement (632 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.c., partial vertebrectomy procedures) due to tumor or trauma (i.e., fracture). The InFix System is designed to restore the biomechanical integrity of the anterior, middle and posterior 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 (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD 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.
The Ardis Interbody System is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD 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.
The Ardis Interbody System is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation.
The BAK/C implant is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. BAK/C implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone.
The BAK device is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels form L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels(s). BAK devices are to be implanted via an open anterior or posterior approach. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
Standard BAK devices and BAK/Proximity devices are to be implanted via an open anterior or posterior approach. BP/Lordotic devices are to be implanted via an open anterior approach.
All BAK devices are also indicated for laparoscopic implantation at the L4-L5 and L5-S1 levels for the same clinical indications described above.
Cadence and TraXis are vertebral body replacement devices that are intended for use in the thoracic and/or thoracolumbar spine (T3-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). These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with bone graft.
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/K143297 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143297: Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143297
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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